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Thierry Lejeune

Porto Potenza Picena, May 2019

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To apply the motor (re)learning principles and guidelines

Following a user-centred designpatients and therapists

Robot = additional therapeutic tool

Why to develop robot to rehabilitate the upper limb ?

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Plan

• RCT : RR & CP children• RCT : RR & Stroke patients

Pilot studies(Fasoli et al., 2008 ; Frascarelli et al., 2009; Fluet et al., 2010 ; Krebs et al., 2009)

Feasibility Efficiency?

Inclusion criteria

Manual Ability Classification System > 1

Without other orthopaedic or neurological disorder of the upper limb

n = 16

Adequate cognition skills

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Recruitment Assessment(n = 16)

Intervention (8 weeks)

Robotic group(n=8)

Control group (n=8)

Randomisation

Protocol

Assessment(n = 16)

- 38 sessions of conventional therapy- 23 sessions of conventional therapy- 15 sessions of Robot-assisted therapy

45 minutes / session

è 38 sessions over 8 weeks5 sessions / week

Robotic group(n = 8)

Control group(n = 8)

“Pragmatic” Daily clinical practice conditions

Protocol Blinded assessor

Recruitment Assessment(n = 16)

Intervention (8 weeks)

Robotic group(n=8)

Control group (n=8)

Randomisation

Assessment(n = 16)

Assessment

KinematicsTasks

Unidirectional & rhythmic

Unidirectional & discrete

Multidirectional & rhythmic

Multidirectional & discrete

10 consecutives times

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Kinematic indices

Optimal path

Subject path

Speed

Peak Speed

(Rorher, 2002)

Speed

SmoothnessStraightness

Accuracy

Kinematic indices

Speed

SmoothnessStraightness

Accuracy

Kinematic indices

Speed

Smoothness

Shape accuracyCoefficient of variation (%)

Reproducible results in the ten consecutive movements?

Kinematic indices

Box and Block test

Assessment

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Robotic group

Results

744 (± 224) Movements/session

Well toleratedNo AE

Typical trace

n=1

Healthy subject

n=1

n=1 n=1

Pre-intervention Post-intervention

Robotic group

Healthy subjectTypical trace

n=1

Control groupRobotic group

n=2 n=2

Typical trace

Pre-intervention Post-intervention

Healthy subject

Treatment effect

Straightness

Control

ΔSt

raig

htne

ss(P

ost-P

re)

Typical trace

Spee

d

Time

Healthy subject

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n=1 n=1

Typical trace

Spee

d

Time

Healthy subject

Pre-intervention Post-intervention

n=2 n=2

Typical trace

Spee

d

Time

Robotic group

Pre-intervention Post-intervention

Healthy subject

Healthy subjectn=3 n=3

Typical trace

Spee

d

Time

Control group

Robotic group

Pre-intervention Post-intervention Smoothness

Treatment effectΔ

Smoo

thne

ss(P

ost-P

re)

Δ

Treatment effect

Box and Block test

Effect of robot-assisted therapy

Kinematics

è Smoother

èMore rectilinear

Manual dexterity was improved

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Plan

• RCT : RR & CP children• RCT : RR & Stroke patients

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To apply the motor (re)learning principles and guidelines

Following a user-centred designpatients and therapists

Robot = additional therapeutic tool

Why to develop robot to rehabilitate the upper limb ?

• high-intensity

• Active movements

• task-specific practice

• feedback on patient’s performance

è Place for a robotic device?

85% suffer from upper limb hemiparesis

Jorgensen et al. 1999; Langhorne et al. 2009 33

Why to develop robot to rehabilitate the upper limb ?

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Why to use robot to rehabilitate the upper limb ?

Are they effective?

0

20

40

60

80

100

120

140

20 1720 1620 1520 1420 1320 1220 1120 1020 0920 0820 0720 0620 0520 0420 0320 0220 0120 0019 9919 9419 88

Pubmed : ("Upper Extremity"[Mesh]AND "Rehabilitation"[Mesh]) and (robot* or electromechanical)

Introduction Introduction

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# RCT # patients2009 11 3282012 19 6662015 34 11602018 45 1619

Introduction

Electromechanical and robot-assisted arm training improves:• ✓ paretic arm function (FM) smd 0,32• ✓ arm muscle strength smd 0,46• ✓ activities of daily living smd 0,31

45 RCT – 1619 subjects

Mehrholz 2018

Introduction

C lin iques un iversitaires Saint-Luc – Thierry Le jeune39

Introduction: EBM

C lin iques un iversitaires Saint-Luc – Thierry Le jeune40

https://rehabilitation.cochrane.org/evidence

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Introduction

Robotic-assisted therapy

Langhorne et al. 2011 42

Introduction

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Zhang et al. 2017

Introduction

Zhang et al. 2017 44

Introduction

Effectiveness of upper limb robotic-assisted therapyin the early rehabilitation phase after stroke:

a single-blind, randomised, controlled trial

Stéphanie Dehem, Maxime Gilliaux, Gaëtan Stoquart, Christine Detrembleur,Géraldine Jacquemin, Sara Palumbo, Anne Frederick & Thierry Lejeune

�,12'232�!"�0" &"0 &""6.#0'+",2�*"�"2� *','/3"

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Evaluate the effectiveness of upper limb robotic-assisted therapy (RAT)

Objective of the study

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- Acute stage of post-stroke

- RAT as partial substitution to conventional therapy (CT)

- According to the 3 ICF domains- Pragmatic trial

- Long term follow-up

• Inclusion criteria:• First stroke• Delay since stroke < 1 month• Age > 18 years• Fugl Meyer UL < 80%• Ability to understand instruction• MMSE ≥ 15

Methods

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• Exclusion criteria:• Stroke located in cerebellum or brain stem• Other neurological or orthopaedic

Recruitment and assessment T0

Intervention 9 weeks

Assessment T1

Stroke

6-monthpost-stroke

Assessment T2

< 1-monthpost-stroke

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RandomisationFollow-up

RAT group

Control group

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Control group

Monday

Tuesday

Wednesday

Thursday

Friday

Physical therapy

Physical therapy

Occupational therapy

RAT

/

/

/

/

/

RAT group

è 36 RAT sessions during 9 weeks4 RAT sessions / week

Monday

Tuesday

Wednesday

Thursday

Friday

Physical therapy

Physical therapy

Occupational therapy

RAT

/

/

/

/

/

Study design

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Robotic device: REAplan®

50www.axinesis.com

Methods

Approved by the Ethical BoardSigned informed consentClinicalTrials.gov : NCT02079779

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Statistics:• Sample size computation: #45• Intention to Treat• two-way Repeated Measures Analysis of Variance

Flow chart

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Results

• RAT group : high intensity of movement (520±437 movements/45 min)

Norouzi-Gheidari et al. 2012; Mehrholz et al. 2015; Verbeek et al. 2016; Zhang et al. 2017 53

• Well tolerated• No adverse event

à In accordance with previous meta-analysis

Equivalence of baselines

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Table 2: Patients’ functional results at each evaluation time and two-way repeated measures ANOVA results comparing the treatment effects between the RAT and CT groups.

ICF domain

RAT group

CT group

Time effect p-value

Group effect p-value

Interaction:

group x time p-value

Effect size of the

difference of improvement (from T0

T0 n=23

T1 n=15

T2 n=15

T0 n=22

T1 n=17

T2 n=13

to T2) between groups, Cohen’s d

Body function and structure

FMA-UE (%) 32.4 (25.4) 51.9 (30.9) 57.1 (33.8) 31.6 (27.0) 42.4 (32.6) 41.6 (34.5) <0.001 0.224 0.058 0.47

BBT (blocks/min) 3.0 (8.3) 9.5 (14.3) 12.7 (17.3) 3.8 (7.5) 6.9 (11.7) 5.1 (9.8) <0.001 0.227 0.021 0.63

Activity

S-WMFT FAS (%) 16.4 (21.4) 32.6 (30.1) 39.0 (36.6) 18.6 (23.6) 24.9 (33.1) 24.8 (32.5) <0.001 0.394 0.024 0.59

Abilhand (%) 36.9 (15.6) 47.1 (20.2) 53.1 (14.1) 41.6 (25.3) 46.6 (21.1) 47.8 (18.8) <0.001 0.947 0.165 0.48

Activlim (%) 38.9 (19.8) 56.2 (21.4) 63.3 (19.1) 44.8 (20.7) 56.6 (25.3) 59.4 (22.3) <0.001 0.881 0.150 0.88

Participation

Stroke impact scale (%) 36.3 (21.4) 50.0 (21.4) 59.4 (24.1) 45.2 (26.6) 50.9 (34.7) 47.5 (31.5) <0.001 0.923 0.011 0.88

Abbreviations: ICF = International Classification of Functioning; RAT = Robotic-Assisted Therapy; CT = Conventional Therapy; SD = Standard Deviation; T0 = assessment at inclusion; T1 = assessment after the 9-week intervention; T2 = assessment at 6 months post-stroke; FMA-UE = Fugl Meyer Assessment Upper Extremity; BBT = Box and Block Test; S-WMFT FAS = Functional Ability Scale of the streamlined version of the Wolf Motor Function Test. Results are presented as mean (SD).

Two way RMANOVA

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Upper limb motor control

Interaction: p=0.058

CID = 7.9%

Page et al. 2012 56

RAT groupControl group

*p<0.05**p<0.001

Gross manual dexterity

Interaction: p=0.021

MDC = 6 blocks

Chen et al. 2009 57

RAT groupControl group

*p<0.05

Interaction: p=0.024

Activity

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RAT groupControl group

**p<0.001

Interaction: p=0.16

MDC = 1.1 %

Penta et al. 2001 59

RAT groupControl group

*p<0.05**p<0.001

Activity Social participation

Interaction: p=0.01

MDC = 17.3%

Lin et al. 2010 60

RAT groupControl group

*p<0.05**p<0.001

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Discussion

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End effector Exoskeleton

Easiest to designEasiest to controlEasiest to use in clinical practice

Shoulder and elbow movementsReaching and not graspingTo favour proximal vs distal recovery ?

Type of robot

Discussion

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To favour proximal vs distal recovery ? No !

Improvement of manual dexterity (BBT)

« …the superiority of a specific type of robot remains unclear… »

Veerbeek 2016

Type of robot

End effector Exoskeleton

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Discussion

64Hsieh 2018

InMotion Wrist InMotion Arm

Discussion

65Hsieh 2018

Discussion

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Cost?

Few data

Cost of the device

Cost of human resource

Discussion

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Robot assisted therapy: 17.831$Usual care: 19.098$

Maserio 2014

“…the costs of such interventions can be considered easily affordable …”

Robot Assisted therapy = 4.15€Traditional individualized therapy = 10.00€

Hesse 2014

LO, 2010

Discussion Take home message

RAT in the acute stage of post-stroke rehabilitation, when provided as partial substitution to CT :Is more effective than CT for:

Gross manual dexterity (Box and Block Test)Upper limb ability during functional tasks (Wolf Motor Function test)Social participation (Stroke Impact Scale)

Ø RAT should be included in clinical practice

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Thank you!Questions?

69 70

Difficulty

Adoption of new technology by cliniciansTeach them Belief vs scientific knowledgeTrain them

Practical use

Transfer form lab to clinic

Discussion

Thank you!Questions?

71