Janice Eng, PhD, Robert Teasell, MD, William Miller, PhD, Dalton Wolfe, PhD, Andrea Townson, MD, Jo-Anne Aubut, BA, Caroline Abramson, MA, Jane Hsieh, MSc, Sandra Connolly, BHScOT, and the SCIRE Research Team

Editors:Janice J. Eng, PhD, BSc (PT/OT), Robert Teasell, MD, FRCPC, William C. Miller, PhD, OT, Dalton Wolfe, PhD, Andrea F. Townson, MD, FRCPC, Jo-Anne Aubut, BA, Caroline Abramson, MA, Jane Hsieh, MSc, Sandra Connolly, BHScOT(C), OTReg. (Ont.)

This review has been prepared based on the scientific and professional information available in 2005. The SCIRE information (print, CD or web site www.icord.org/scire) is provided for informational and educational purposes only. Please feel free to use this information, as seen fit, without alteration. If you have or suspect you have a health problem, you should consult your health care provider. The SCIRE editors, contributors and supporting partners shall not be liable for any damages, claims, liabilities, costs or obligations arising from the use or misuse of this material.

Table of Contents

Start Page Forward ....................................................................................................................i Acknowledgements ................................................................................................ii Executive Summary ................................................................................................iii Editors ......................................................................................................................ix Contributors ............................................................................................................x

End Page i ii viii ix xi

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9

Rehabilitation: From Bedside to Community Following Spinal Cord Injury (SCI) .................................................................... 1-1 Methods of the Systematic Reviews ................................................ 2-1 Rehabilitation Practice and Associated Outcomes Following Spinal Cord Injury ............................................................................. 3-1 Community Reintegration Following Spinal Cord Injury .................... 4-1 Upper Limb Rehabilitation Following Spinal Cord Injury ................... 5-1 Lower Limb Rehabilitation Following Spinal Cord Injury ................... 6-1 Cardiovascular Health and Exercise Following Spinal Cord Injury.... 7-1 Respiratory Management Following Spinal Cord Injury .................... 8-1 Bone Health Following Spinal Cord Injury ......................................... 9-1

1-11 2-11 3-44 4-37 5-58 6-34 7-28 8-30 9-18 10-19 11-40 12-17 13-77 14-32 15-25 16-17

Chapter 10 Depression Following Spinal Cord Injury .......................................... 10-1 Chapter 11 Sexual Health Following Spinal Cord Injury ...................................... 11-1 Chapter 12 Neurogenic Bowel Following Spinal Cord Injury ............................... 12-1 Chapter 13 Bladder Health and Function Following Spinal Cord Injury .............. 13-1 Chapter 14 Pain Following Spinal Cord Injury .................................................... 14-1 Chapter 15 Venous Thromboembolism Following Spinal Cord Injury ................. 15-1 Chapter 16 Orthostatic Hypotension Following Spinal Cord Injury ...................... 16-1

Table of Contents (Cont.)Start Page Chapter 17 Autonomic Dysreflexia Following Spinal Cord Injury ......................... 17-1 Chapter 18 Heterotopic Ossification Following Spinal Cord ................................ 18-1 Chapter 19 Nutrition Issues Following Spinal Cord Injury .................................... 19-1 End Page 17-27 18-8 19-13

Chapter 20 Pressure Ulcers Following Spinal Cord Injury ................................... 20-1 20-26 Chapter 21 Spasticity Following Spinal Cord Injury ............................................. 21-1 21-56 Chapter 22 Outcome Measures .......................................................................... 22- 1 22-89

Eng JJ, Teasell RW, Miller WC, Wolfe DL, Townson AF, Aubut J, Abramson C, Hsieh JTC, Connolly S, editors. Spinal Cord Injury Rehabilitation Evidence. 2006: Vancouver. www.icord.org/scire

FORWARD Over the past few years, the volume of publications encompassing a broad definition of rehabilitation after spinal cord injury (SCI) has expanded exponentially. As in all rapidly expanding research fields, it is helpful, from time to time, to review what has been published and assess the quality of the data and conclusions of these reports. Thus was born the SCIRE project. This manual represents the first comprehensive synthesis of the published evidence on rehabilitation strategies and community-based programs designed to improve the functional outcomes and quality of life for people living with a SCI. It is primarily intended as a guide for professionals in the areas of SCI health care and community care. It should also prove useful to SCI researchers, public policy makers, and people with SCI and their families. The goal is to provide everyone with the necessary objective information to make better-informed decisions as to the strength and validity of current rehabilitation programs and emerging strategies, as well as to identify gaps in our knowledge and possible research priorities. A knowledge translation project as large as SCIRE requires clearly identified validation criteria and the coordinated efforts of a large number of individuals. The more than 40 invited reviewers from across Canada have long-standing expertise on the topics they reviewed. Drs. Janice Eng, Robert Teasell and William Miller provided the vision, framework and critical leadership for SCIRE and the ensuing team work between the Vancouver and London sites. Their tireless efforts ensured the timely release of this first version. Version 1 is just the beginning of SCIRE activities. In the years to come, we can anticipate revised versions of SCIRE, as new SCI research evidence comes to light and future best practices in SCI rehabilitation are validated. In addition, this compilation can form a basis for activities such as the development of clinical practice guidelines and identification of disparities between current practice and best practice. On behalf of ICORD, The Ontario Neurotrauma Foundation, and The Rick Hansen Foundation, we offer thanks and congratulations to everyone who contributed to the successful launch of SCIRE.

John D. Steeves John and Penny Ryan BC Leadership Professor Director of ICORD Vancouver, Canada

September 2006

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ACKNOWLEDGEMENTS This large-scale project represents the collaborations and tremendous efforts of so many dedicated people. We would like to thank the funding agencies that provided financial support the Rick Hansen Man in Motion Foundation and the Ontario Neurotrauma Foundation. The SCIRE Advisory Committee met regularly to provide feedback on the process and translation methods for the SCIRE project and their input was invaluable. The SCIRE Advisory Committee members: Caroline Abramson, Research Coordinator, GF Strong Rehab Centre/University of BC Jo-Anne Aubut, Research Coordinator (Parkwood, London) Karen Anzai, Rehab Consultant, SCI Program, GF Strong Rehab Centre Sandra Connolly, OT, Spinal Cord Program (Parkwood, London) Armin Curt, MD, Research Chair, ICORD Chris Fraser, Reg. Dietician, SCI & ABI Programs, SCI consumer (Parkwood, London) Chris McBride, PhD, Managing Director, ICORD Dave Metcalf, Vocational Counselor, SCI consumer (GF Strong Rehab Centre) Kelly Moore, Educator, SCI Program, GF Strong Rehab Centre Steve Orenczuk, PsyD, SCI program (Parkwood, London) Andrea Townson, MD, FRCPC, GF Strong Rehab Centre, Co-PI, SCIRE Project Dalton Wolfe, PhD, SCI (Parkwood, London) Daryl Rock, Associate Director, Knowledge Exchange Canadian Council on Learning In addition to the editors and contributors already recognized, several individuals made significant contributions to assessing and extracting data from Vancouver: Jennifer Cumal, Nicole Elfring, Marcia Fukunaga, Chihya Hung, Emily Procter, and Jeff Tan and from London: Joan Conlon and Dr. Jeff Jutai. We are grateful to the GF Strong Rehab Centre (Vancouver Coastal Health), Parkwood Hospital (St. Josephs Health Care) and Lawson Health Research Institute which provided the space and infrastructure support for undertaking the project. Wed also like to recognize the support from ICORD, in particular, Cheryl Niamath for her graphic designs and endless patience, Dave Pataky for his web and CD development and Dr. John Steeves for his guidance. Lastly, wed like to express our gratitude to the many SCI rehabilitation scientists and clinicians who spent endless hours putting the chapters together and made this project possible.

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EXECUTIVE SUMMARY 1. SCIRE Project overview The Spinal Cord Injury Rehabilitation Evidence (SCIRE) is a synthesis of the research evidence underlying rehabilitation interventions to improve the health of people living with SCI. SCIRE covers a comprehensive set of topics relevant to SCI rehabilitation and community re-integration. This project is intended to translate existing knowledge to health professionals to inform them of best practice. This research synthesis will also enable relevant decision-making in public policy and practice settings applicable to SCI rehabilitation. In addition, transparent evidence-based reviews can guide the research community and funding organizations to strategically focus their time and resources on the gaps in knowledge and identify research priorities. People with SCI and their families may also find the information useful to understanding their health care. The Spinal Cord Injury Rehabilitation Evidence developed from a research collaboration between Vancouver and London (Ontario) and involved their respective health centres (GF Strong Rehab Centre, St. Josephs Health Care), research institutions (International Collaboration on Repair Discoveries, Lawson Health Research Institute) and universities (University of BC, University of Western Ontario). 2. Methods Systematic Review An exhaustive search (keyword literature search, previous practice guidelines and systematic reviews, review articles) was used to identify published literature evaluating the effectiveness of any treatment or therapy related to SCI rehabilitation. Topics relevant to rehabilitation were selected with input from scientists and clinicians in the field of SCI rehabilitation, in addition to the SCIRE Advisory Committee (which included consumers with SCI and policy-makers). This search involved the review of over 17,000 titles and 8400 abstracts, and a final extraction and synthesis of almost 700 articles. A variety of study designs were included (from randomized controlled trials to case reports), however, controlled trials were given priority in generating conclusions. In order to provide transparent and unbiased evidence-based reviews, the rigor and quality of each study was scored on standardized scales by two independent reviewers (Physiotherapy Evidence Database Scale for randomized controlled trials and the Downs and Black Tool for all other studies). Following this individual study assessment, conclusions were drawn about the accumulated studies for each topic of interest (e.g., pressure ulcers) using a modified version of Sacketts description of levels of evidence. In this 5 point scale, the strongest evidence, level 1, was assigned if the intervention was supported by at least one randomized controlled trial, while a level 5 was assigned if no critical appraisal existed, but perhaps was supported by clinical consensus. Conclusions were based on the levels, quality and concurring evidence. When conflicting data was present, an explanation was provided as to how the conclusions were derived. Outcome measure assessment Outcome measures used in spinal cord injury evaluation were identified by keyword search of the major electronic databases and through hand searches of noted spinal cord journals. Only measures with published studies of the psychometric (reliability and validity) properties within the spinal cord population were identified for review. The measures were categorized into the

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domains of the World Health Organizations International Classification of Functioning, Disability and Health (body function/structure, activity and participation). A fourth category was created for quality of life measures. Approximately 160 measures were identified of which 63 were selected for review based on clinician interest. The measures were evaluated using elements of the Health Technology Assessment to assess the psychometric properties, interpretability, acceptability, and feasibility. Summary tables identifying the rigor and quality of the psychometric properties were constructed. A clinical conclusion is offered based on the synthesis of the review. 3. Findings from the Systematic Review of SCI Rehabilitation Given that the SCIRE consists of over 800 pages of evidence, we cannot represent all the findings here. What follows are selected findings which demonstrate the scope of the research and the value of the results. Rehabilitation Practice Earlier admission to specialized, interdisciplinary SCI care is associated with reduced length of total hospital stay and greater and faster rehabilitation gains with fewer medical secondary complications (especially pressure sores). Community Re-integration The average level of quality of life after SCI is slightly lower than in people without disability but a substantial number of people with SCI report good or excellent levels of quality of life. The severity of injury and other diagnostic factors do not significantly impact quality of life. Their influence may become significant through restrictions in community integration or social participation. Upper Limb Rehabilitation Upper limb muscle strength is identified as an important contributor to functional independence. Neuromuscular stimulation-assisted exercise (e.g., during arm ergometry) following a spinal cord injury is effective in improving muscle strength, preventing injury and increasing independence in all phases of rehabilitation. Practice of repetitive movements in conjunction with low intensity peripheral nerve stimulation may induce beneficial brain cortical changes, in addition to improved arm and hand function. Lower Limb Rehabilitation Body-weight supported treadmill exercise using a suspended harness is a relatively new treatment of interest. For patients less than 6 months post-SCI, body weight supported treadmill training has equivalent effects on gait outcomes to conventional rehabilitation consisting of overground mobility practice. Body weight-support gait training strategies can improve gait outcomes in chronic, incomplete SCI, but no single specific body weight-support strategy (overground, treadmill, with functional electrical stimulation) is more effective. Cardiovascular Health and Exercise There appears to be an earlier onset and increased prevalence of cardiovascular disease in individuals with SCI in comparison to the general population. Tetraplegics and paraplegics can improve their cardiovascular fitness and physical work capacity through aerobic exercise training (e.g., arm cycle or wheelchair ergometry), which are of moderate intensity, performed 20-60 min day, at least three times per week for a minimum of six to eight weeks.

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Respiratory Management Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Unlike the cardiovascular system, the lungs and airways do not change appreciably in response to exercise training. For exercise training to improve respiratory function, the training intensity must be relatively high (70-80% of maximum heart rate) performed three times per week for six weeks. Bone Health There is a significant risk for lower extremity fragility fractures after SCI. Early assessment and ongoing monitoring of bone health is an essential element of SCI care. There is strong evidence from randomized controlled trials that support the use of medications for the prevention and treatment of bone loss following SCI. Non-pharmacological treatments have not been found to prevent bone loss in the first year, however, electrical stimulation can increase bone density over the area stimulated in people with SCI more than 1 year post-injury. Depression Depression is a common consequence of SCI. Cognitive behavioural interventions provided in a group setting appear helpful in reducing post-SCI depression. The benefits of drug treatment (including selective serotonin reuptake inhibitors and tricyclic antidepressants) in combination with psychotherapy may alleviate depression. However, pharmacological management for postSCI depression is largely extrapolated from studies in non-SCI populations. Programs to encourage regular exercise, reduce stress, and improve or maintain health are beneficial in reducing reports of depressive symptoms in persons with SCI. Sexual Health In men with SCI, erections are often not reliable or adequate for sexual intercourse since there may be difficulties with maintenance of the erection. The pharmacological agent, Phosphodiesterase Type 5 Inhibitors (PDE5i, Viagra) can be used safely and effectively for treatment of erectile dysfunction in men with SCI and are recommended as first line treatment for erectile dysfunction after SCI. Bowel Management Multifaceted programs incorporating intereventions such as, nutrition, fluid consumption, routine bowel evacuation, may improve movement of substances through the colon as well as decrease the incidences of difficult bowel evacuations. Pharmacological agents such as cisapride, prucalopride, and metoclopramide are effective for the treatment of chronic constipation in persons with SCI. Bladder Management Disruption of the signals from the brain resulting from a SCI prevents normal voluntary voiding without assistance. Intermittent catheterization and spontaneous triggered voiding are associated with the lower complications compared to indwelling catheters. Intermittent catheterization may be difficult to continue at home for those with tetraplegia and complete injuries. Assistive devices may enhance compliance with intermittent catheterization for those with impaired hand function. Pain Management Pain following a SCI is common, often severe and has a significant effect on quality of life. A shoulder exercise protocol (consisting of shoulder stretching and strengthening) reduces the intensity of shoulder pain post-SCI. Reduce pain may be achieved from massage, heat, v

acupuncture or hypnosis. A number of pharmacological agents can provide pain relief, including the anticonvulsant Gabapentin, Intrathecal Baclofen, and Lidocaine through a subarachnoid lumbar catheter. Tricyclic antidepressants and Intrathecal Clonidine have not been shown to reduce post-SCI pain. Venous Thromboembolism Venous thromboembolism (blood clot) is very common in untreated spinal cord-injured patients. The pharmacological agent low molecular weight heparin is more effective than standard heparin in reducing the risk of venous thromboembolism post-SCI with less bleeding complications. Physical interventions such as pneumatic compression or pressure stockings may have some additional benefits when used in combination with pharmacological agents. Orthostatic Hypotension Orthostatic hypotension is an excessive reduction in blood pressure with changes in body position and can result in lightheadedness or dizziness. It is commonly experienced following SCI due to the loss of muscle activation. Although a wide array of physical and pharmacological measures are recommended for the general management of orthostatic hypotension, very few have been evaluated for use in SCI. Of the pharmacological interventions, only midodrine was found to be effective, while functional electrical stimulation is one of the only nonpharmacological interventions which demonstrates some evidence to support its use. Autonomic Dysreflexia Autonomic dysreflexia is a potentially life-threatening acute elevation of blood pressure commonly experienced post-SCI. The identification of the possible trigger and decrease of sensory stimulation to the spinal cord is the most effective prevention strategy. Urinary bladder irritation is one of the major triggers of autonomic dysreflexia following SCI. The pharmacological agents, nifedipine or captopril are commonly used and can prevent or control autonomic dysreflexia in SCI individuals. Heterotopic Ossification Heterotopic ossification, the formation of pathological bone in muscle or soft tissue, occurs frequently in the first two months following SCI. Anti-inflammatory medications or warfarin (anticoagulant) can reduce the risk of heterotopic ossification post-SCI. Once ossification is identified, the pharmacological agent, etidronate or radiation therapy can reduce the progression of heterotopic ossification. Nutrition There is an increased risk for obesity, abnormal lipid metabolism, cardiovascular disease, impaired glucose regulation and diabetes mellitus post-SCI. Standard dietary counseling (daily total fat 1yr. Treatment: Information and social meetings between female students and individuals with SCI. The comparison group had information alone. After the activity the students had posttest measurements, and patients had a verbal posttest Outcome Measures: Attitude Toward Disabled Person (ATDP) scale, Student Comfort Level Scale (SCLS), Patient Comfort Level Scale (PCLS), Student Satisfaction Measurement Form (SSMF), Patient Satisfaction Measurement Form (PSMF), Patient Post-Measurement (PPM) form. Population: all female, age range 2561yrs, traumatic or non-traumatic, 4 cervical (tetraplegia) and 9 thoracic (paraplegia), DOI 2-11yrs. Treatment: Two interviews obtaining etiology info and current situation regarding social network and their ability to participate in occupation. Outcome Measures: perceptions of change in social network and participation. Outcome 1. There was a significant difference between the groups on their pre- and post-scores for the Attitude Toward Disabled Persons scale (F=7.36, p=.001) (treatment group (t=5.6, pcortical bone). Specifically, the decreased systemic calcium and vitamin D (with subsequent increase in parathyroid hormone) that results from SCI can be accentuated by inadequate dietary calcium intake, decreased sunlight exposure and the potential for hyperparathyroidism (Bauman et al. 1995). Further evidence suggests that women with a complete SCI experience bone loss around the hip and knee during menopause that is greater than age-matched able-bodied women (Garland et al. 2001). These factors all contribute to the increased risk for low-trauma or fragility fractures in people who sustain a SCI. 9.2 Fracture Risk following a SCI There is overwhelming evidence that supports the importance of addressing bone health issues early after a SCI. A high incidence of lower extremity fragility fractures (1-46%) exist in people who sustain a SCI (Table 9.1); the majority of fragility fractures occur following transfers or activities that involve minimal or no trauma (Ragnarsson & Sell, 1981). The distal femur and proximal tibia are most at risk, consistent with site-specific decreases in bone mineral density around the knee such that fractures of the distal femur are referred to as the paraplegic fracture (Comarr et al. 1962). There are many notable risk factors for fragility fracture after SCI. There is a greater risk for women compared with men (Vestergaard et al. 1998; Garland et al. 2004), also with increasing age and longer time since injury. Further, paraplegics have more fractures compared with tetraplegics and those with complete injuries have greater bone loss compared with incomplete injuries (Garland et al. 2004). In the general population, individuals with a prior history of fragility fracture or a maternal history of fracture have a greater risk for future fracture, and these risk factors should also be considered in people with SCI.

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Table 9.1 Fracture Incidence and risk factors for Fragility fractures after SCIFirst Author /Year Comarr et al. 1962 Ragnarsson & Sell 1981 Freehafer 1995 Frisbie 1997 Vestergaard et al. 1998 McKinley et al. 1999 Lazo et al. 2001 Nelson et al. 2003 Zehnder et al. 2004 41 45 100 0.4-30 yrs 60 27-83 >10 months 2112 yrs > 1 yr Men; Family history of fractures Women >Men; Time since injury Time since injury; tibia BMD Age Age Time to 1st Fracture Fracture incidence 6% 4% Risk Factors A complete injury > risk than incomplete injury.

Women >Men; Family history of fractures; Time since SCI > 3 years

Garland et al. 2004

28

Fracture BMD threshold < 0.86 gm/cm2; breakpoint BMD at 0.49 gm/cm2; Women >Men Age; low BMI; Completeness of injury post SCI

Fragility fractures, especially around the knee, are very common in people with SCI. 9.3 Bone Outcome Measures Evaluation of bone occurs in many ways depending on the tools used for investigation. Common methods of bone evaluation include urine and blood (serum) analyses yielding biochemical markers to quantify rates of bone turnover. The most commonly used biochemical markers of bone turnover include osteocalcin, n-telopeptide and hydroxyproline. Areal bone mineral density is quantified non-invasively with imaging technologies such as dual energy X-ray absorptiometry (DXA) and previously with dual energy photon absorptiometry (DPA). Dual energy X-ray absorptiometry is considered by the World Health Organisation as the gold or criterion standard to diagnose osteoporosis and is the most widely used assessment technique for osteoporosis. DXA can measure BMD for the spine, hip or the limbs at relatively low cost and minimal risks to the patient. Volumetric bone mineral density is assessed using peripheral quantitative computed tomography (pQCT). Peripheral quantitative computed tomography (pQCT) is a safe and precise technique to differentiate cortical from trabecular bone and assess both bone geometry and volumetric density. Histomorphometry are measurements from bone biopsies and analyzed at the tissue and cellular level to provide an in-depth understanding of bone. There are two types of bone histomorphometry, dynamic and static. Dynamic histomorphometry involves using substances

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such as tetracycline to measure tissue growth. Static histomorphometry involves determining the size and types of cells; measurements include length, area or cell counts. Static histomorphometry involves embedding bone in a resin then sanding the specimen down until it is very thin ( 1 year after the injury). The intent is to address two distinct clinical questions: 1.What is the best way to prevent acute regional declines in bone mineral density?; and 2. What are the best treatments for low bone mass of the hip and knee region for people with longstanding SCI? 9.4 Pharmacologic Therapy: Bisphosphonates Within weeks after SCI, there is a marked increase in bone resorption (taking bone away) with a decrease in bone formation (adding new bone) and this is responsible for the significant loss in BMD. Bisphosphonates are a group of medications that are used to prevent declines in bone mass or treat low BMD; they act to slow down excessive bone resorption. Etidronate (Didrocal), Alendronate (Fosamax) and Risedronate (Actonel) are oral bisphosphonates, which are currently approved for the treatment of postmenopausal osteoporosis in Canada (Brown et al. 2002). Clodronate (Benefos or Ostac) is available intravenously (IV) and orally for the treatment of osteoporosis. Tiludronate (Skelid) is available in oral form in the United States. Giving calcium and vitamin D at the same time as bisphosphonate therapy has the potential for greater efficacy for bisphosphonates. Concurrent supplementation with calcium and vitamin D have been important additions to bisphosphonate therapy for other medical conditions (such as postmenopausal osteoporosis) (Brown et al. 2002). 9.4.1 Pharmacologic Therapy: Prevention (within 12 months of injury) Table 9.2 Prevention Studies using Pharmacology for Bone Health after a Spinal Cord Injury.Author Year; Country Score Research Design Total Sample Size Methods Population: 14 men and women, ages 2161, motor complete para/ tetraplegia. Treatment: Pamidronate for 12 months. Participants randomized to 1. 60mg IV or placebo(saline) at 1, 2, 3, 6, 9, 12-mos. post SCI (N=6). 2. Placebo (N=5). Outcome measures: BMD by DXA, bone turnover markers. Population: 21 men and women, ages 1554 years, complete paraplegia. Treatment: Clodronate for 3.5 months. Participants randomized to 1. 400mg per day (N=7); 2.1,600 per day (N=7); or 3. Placebo (N=7). Outcome measures: BMD dual photon absorptiometry (DPA), histomorphometry 1. 2. Outcome There was no significant between group differences in BMD decline at 1 year. The treatment group had significantly lower 24-hr urinary calcium at 1month vs. placebo group (P 1 year were included with the treatment literature as the majority of their participants were in the chronic phase. 9.5.1 Non-Pharmacologic Therapy: Prevention (within 12 months of injury) Table 9.4 Prevention Studies Using Rehabilitation Modalities for Bone Health after SCIAuthor Year; Country Score Research Design Total Sample Size Methods FES-cycle ergometer Population: 38 men and women, mean 1. age = 33, complete injuries between C5T12, (19 participants, 19 controls). Treatment: FES-cycle ergometer. Progressive training sessions until able to cycle for 30 mins. Then 3x/wk for 6 mos. from this baseline. On the remaining 2days of the week there was passive standing. Control group performed 30 mins. of passive standing 5 days/week. Outcome measures: CT Standing/Walking Population: 19 men, ages 19-59, injuries 1. between C4-T12, ASIA: A-D Treatment: Standing/Walking. Group 1 had 0-5 hrs per week loading exercises with standing frame. Group 2 had 5+hrs of standing exercises per week (standing). Group 3 had 5+hrs of standing and treadmill (walking). Interventions lasted 25 wks. Outcome Measures: vBMD by pQCT Treadmill training Population: 2 men and 3 women, ages 19-40, injuries between C3-C8, ASIA: B and C. no controls. Treatment: Body-weight supported treadmill training. Initial session started at 5mins and was gradually to 10-15mins in all but 1 participant during 48 sessions of 2x/wk-training over a period of 6-8 months. Outcome measures: BMD by DXA and CT. Ultrasound Population: 15 men, ages 17-40, injuries between C5-T10, ASIA: A-B, (within group design) Treatment: Pulsed therapeutic ultrasound. Applied to both calcanei for each participant for 20 min/day, 5x/wk over a consecutive 6-wk period. Right and left calcaneus within each participant was randomized. Outcome measures: BMD by DXA and quantitative ultrasound (QUS). 1. 2. 3. Outcome

Eser et al. 2003; Switzerland Downs & Black score=14 Prospective Controlled Trial N=38

Both groups had a 0-10% in tibial cortical BMD. There was no difference between groups for BMD after the intervention.

de Bruin et al. 1999; Switzerland PEDro=6 RCT N=19

Marked in trabecular BMD at the left tibia for the immobilized group but minimal in trabecular BMD in Group 2 and 3.

Giangregorio et al. 2005; Canada Downs & Black score=13 Pre-post N=5

in BMD for all participants at almost all lower limb sites after training, ranging from -1.2 to -26.7%. Lumbar spine BMD changes ranged from 0.2 to -7.4%. No consistent changes in bone geometry at distal femur and proximal tibia. Did not alter the expected pattern of change in bone biochemical markers over time.

1.

For specified dose, no significant effect of QUS for any skeletal measurement parameter (p>0.05).

Warden et al. 2001; Australia PEDro=11 RCT N=15

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Discussion Evidence for non-pharmacological prevention of SCI bone loss includes 4 investigations (n=77 participants). This includes 2 RCTs (34 participants), 1 non-randomized controlled trial (38 participants) and 1 pre-post studies (5 participants) (Table 4). As with pharmacology prevention studies, there were difficulties with interpretation because of low numbers of participants and variability with the primary outcome measures. For each of the four different modalities there is only one study available and there was variability for the primary outcome of interest. Only the therapeutic ultrasound study by Warden and coworkers found no significant improvement in bone health after a 6 week intervention. Although prospective observational data (Frey-Rindova et al. 2000) highlight the loss of bone in the early phase (first 6-months post SCI), there was no significant influence of self-reported physical activity level. Overall, the evidence suggests that rehab modalities were not successful in reducing bone loss in the acute phase after SCI. Conclusion For NON-PHARMACOLOGICAL PREVENTION of bone loss after a SCI: There is Level 1 evidence from one RCT that short-term (6 weeks) ultrasound is not effective for treating bone loss after a SCI. There is Level 2 evidence that FES-cycling did not improve or maintain bone at the tibial midshaft in the acute phase. There is Level 4 evidence that walking and standing in the acute phase did not differ from immobilization for bone loss at the tibia.

Short term (6 weeks) therapeutic ultrasound is not effective for preventing bone loss after a SCI. FES-cycling does not improve or maintain bone at the tibial midshaft in the acute phase.

9.5.2 Non-Pharmacologic Therapy: Treatment In this section, non-pharmacological rehabilitation treatment modalities are divided into 4 subsections: Patterned electrical stimulation (PES), functional electrical stimulation (FES) cycle ergometry, standing and walking (Tables 5-7). Both PES and FES use cyclical patterns of electrical stimulation that simulate muscular activity. However, FES is directed towards the attainment of purposeful tasks such as cycling or walking. PES, on the other hand, is focused on producing muscle contractions (isometric, isotonic). In some applications, PES techniques are used as a training stimulus to prepare muscles for a subsequent FES training condition.

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9.5.2.1 Electrical Stimulation Table 9.5 Treatment Studies Using Electrical Stimulation for Bone Health after SCIAuthor Year; Country Score Research Design Total Sample Size Methods Population: 14 men and women, ages 2342, complete and incomplete injuries between C5-T6, 14 able-bodied controls. Treatment: PES. Quadriceps training was conducted 5 days/wk for 24 wks. Participants trained for 1hr/day or until fatigue. Right quadriceps were stimulated with no resistance (but against gravity) while the left quadriceps were stimulated against a resistance. Outcome measures: BMD by DXA Population: 12 men and women, ages 1963, para/tetraplegia, complete/incomplete, no controls (only 9 participants had BMD) Treatment: PES. Each participant trained for a total of 36 sessions (3x/wk for 12wks) using a progressive intensity protocol for PES stimulated knee extension. This progression was continued to a maximum 15 kg load. Outcome measures: BMD by DXA Population: 10 men and women, ages 2745, injuries either C6 or T2, no controls Treatment: PES. Stimulated the legs for 30 min, 3x/wk for 12 mos. followed by 1x/wk for 6 mos. Outcome measures: BMD by DXA, biochemical markers. 1. Outcome At baseline BMD from the experimental group was lower at the distal femur, proximal tibia and midtibia ( range: 25.8% to 44.4%) than able-bodied controls. BMD with training (p0.05), but BMD was better than predicted values.

Blanger et al. 2000; Canada PEDro=11 Prospective Controlled Trial N=28

2.

1.

Rodgers et al. 1991; USA Downs & Black score=10 Pre-post N=12

1.

Mohr et al. 1997; Denmark Downs & Black score= 9 Pre-post N=10

2. 3.

After 12 mos. of training, there was a significant 10% in proximal tibia BMD (p< 0.05) but no change at the lumbar spine or femoral neck. After 6 mos. of reduced training, BMD for the proximal tibia returned to baseline. Blood and urine markers were within normal limits at baseline and there was no significant change with PES.

Discussion Although there were no randomized controlled trials that assessed the effect of patterned electrical stimulation, Blanger et al. (2000) produced impressive results with a level 2, nonrandomized trial which used 1 limb as the treatment and the other as the control limb. Following training, the BMD recovered 30% of bone loss compared with able-bodied values. Stimulation effects only occur over the areas of stimulation and return to baseline within months once stimulation is stopped (Mohr et al. 1997). Conclusion There is Level 2 evidence that electrical stimulation either increased or maintained BMD over the stimulated areas.

Electrical stimulation can maintain or increase BMD over the stimulated areas.

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9.5.2.2 FES Cycle Ergometry Table 9.6 Treatment Studies Using FES Cycle Ergometry for Bone Health after SCIAuthor Year; Country Score Research Design Total Sample Size

MethodsPopulation: 15 men, ages 23-37, complete, C6-T8. 15 able-bodied controls Treatment: FES-cycle ergometer. Participants performed FES-cycling exercises with minimal resistance for 30 minutes/day, 5 days/week for 6 months. Follow-up 6 months after intervention. Outcome measures: BMD by DXA 1. 2.

Outcome At baseline, participants BMD at the femoral neck, distal femur and proximal tibia was lower than controls. After 6 months, BMD of the distal femur and proximal tibia significantly (p0.05) showed a trend toward increasing. BMD in the distal femur, proximal tibia, and heel significantly after 6 mos. without intervention (p0.05). The BMD of the proximal femurs were below normal before commencing exercise intervention (compared with matched able-bodied individuals). After 7 months of exercise training there was no significant difference in BMD for any of the sites of the proximal femurs compared to normal values. At baseline, SCI participants were not significantly different from agedmatched able-bodied ambulatory men for lumbar-spine BMD. However, BMD was significantly lower for participants at the hip (p