Upper Arm Reahabilitation After Stroke and Video Game (MARGAUT)

Effect of Early Upper Arm Rehabilitation After Stroke Using Adaptative Video Games

The purpose of this study is to assess the efficiency of occupational therapy enhanced by "dedicated adaptative video games" in rehabilitation of the upper arm of stroke patients in the acute phase after their cerebro-vascular accident. Our hypothesis is that occupational therapy enhanced by dedicated adaptative video games is more efficient in improving motor recovery of the upper arm than conventional occupational therapy alone.

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebro-vascular Accident; Upper Arm Disability; Reaching; Grasping
• Intervention / Treatment: Procedure: serious game reeducation; Procedure: functional MRI

Detailed Description

Introduction : Stroke constitutes one of the most disabiliting desease in industrialized countries, leading to major deficiencies, especially in the upper arm (concerning 50 to 80% of post-stroke patients). Upper arm rehabilitation after stroke improved during the last ten years, with the development of new rehabilitation methods including constraint induced therapy, mirror therapy, mental imaging, virtual reality and robotics. Video games and virtual reality are very promising in this field, and the development of new adaptative games dedicated to upper arm rehabilitation after stroke is necessary to enhance the benefit of those devices in therms of sensori-motor and functional recovery.

Objectives: To prove the efficiency of video-gaming (using dedicated adaptative games) on recovery of motor function of the upper armafter stroke, compared to a "conventional" rehabilitation program.

Design: Multicentric Randomized Controlled TrialParticipants: 50 early stroke patients and 12 healthy control persons will be included in this trial. Inclusion criteria for patients are as follow: age>18, onset of stroke <6 weeks, first unique supra-tentorial ischemic or haemorrhagic stroke, Fugl Meyer score of the upper arm < 30/66 at inclusion. Exclusion criteria are as follow: severe neglect or aphasia, upper arm severe orthopedic limitation, shoulder pain > 5/10, contra-indication to MRI.

Methods:All patient will get a "standard program" of rehabilitation 5 days/week duiong six weeks, including physiotherapy (one or two sessions/day), occupational therapy (one session/day) and speech therapy if necessary (one session/day). Patients will be randomized in two groups: the "treated group" receiving an additional session of 30 to 45 minutes of daily rehabilitation with video games under the supervision of an occupational therapist, and the "control group" receiving the same anount of "standard rehabilitation" provided by an occupational therapist.Assesment will be conducted at inclusion (J0), at the end of the program (Week 6: W6) and at follow-up (end of month 6: M6)).

Recorded datas: The primary endpoint is the difference in increasing the upper arm Fugl Meyer Score (FMS) between both groups at W6. Secondary criterions include: FMS at M6, Box and Block Test at W6 and M6, Nine Hole Peg test at W6 and M6, Wolf Motor Function Test at W6 and M6, Motor Activity Log at W6 and M6, Barthel Index at W6 and M6, SF-36 at W6 and M6. Functional MRI and tensor diffusion imaging will also be conducted in 25 patients and 12 controls, at J0 and W6. Evolution of cerebral plasticity and correlations between cerebral re-organisations and kinematic characteristics of upper arm movements will be provided.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age > 18
• onset of stroke < 6 weeks
• first unique supra-tentorial ischemic or haemorhagic stroke
• Fugl Meyer score of the upper arm < 30/66 at baseline

Exclusion Criteria:

• severe neglect or aphasia
• upper arm severe orthopedic limitation
• shoulder pain > 5/10
• pregnancy < 3 months
• Contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Serious game; In this group, patients will have a session of conventional retraining with a serious game retraining.	Procedure: serious game reeducation; It's a daily session (45 minutes) of reeducation by serious game (kinect) compared to a daily session (45 minutes) of conventional reeducation; Procedure: functional MRI; the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.
Active Comparator: control patients; In this group, patients will have the conventional retraining with an other conventional retrainning session. The difference between both groups of patients is the serious game session for one group and conventional session for the other group	Procedure: serious game reeducation; It's a daily session (45 minutes) of reeducation by serious game (kinect) compared to a daily session (45 minutes) of conventional reeducation; Procedure: functional MRI; the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.
Placebo Comparator: controls; For the neurologic assessments, patients are compared to healthy patient (without stroke)	Procedure: functional MRI; the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy assessment of the serious game on the recovery of the upper limb	Difference in increase of the Upper Arm Fugl Meyer Score (max: 66) between both groups, at the end of the rehabilitation program (week 6)	at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Score between both groups	Difference in increase of the Upper Arm Fugl Meyer Score (max: 66) between both groups, at the end of the study(6 months)	at 6 Months
Box and Block Test assessment between both groups	The box and block test assess the global capacities of prehension of patients. It's important to compare these capacities between both groups of treatment.	at 6 Weeks and 6 Months
Wolf Motor Function Test assessment between both groups.	To assess the motor capacity by the Wolf motor funtion at 6 Weeks and after 6 Months.	at 6 weeks and at 6 months
Motor Activity Log assessment between both groups	This test assess the frequency of use and the quality of the movement.	at 6 weeks and at 6 months
Barthel Index and SF-36	The Barthel Index assess the global functional capacities by a score (calculated /100)between both groups of patients. The SF-36 is a self-questionnaire which permits the evalulation of quality of life.	at 6 weeks and at 6 months
Functional MRI Assessment between controls and patients	Functional MRI permits to study of the topographics neuronal circuits involved in the recovery of the motor functions of the upper limb: evaluation of the profiles of activation involved in the execution of the movement of fingers flexion / extension involving the right hemisphere and then the left hemisphere.	at baseline and at 6 weeks
Nine Hole Peg test assessment between both groups	To assess the efficacy of Serious Game on manual dexterity on the duration of Nine Hole Peg test.	at 6 weeks and at 6 months
tensor diffusion analysis between controls and patients	The tensor diffusion imaging will also be conducted in 25 patients and 12 controls, at baseline and at 6 weeks. Evolution of cerebral plasticity and correlations between cerebral re-organisations and kinematic characteristics of upper arm movements will be provided.	at 6 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Laffont Isabelle, MD, PhD, CHRU de Montpellier

Publications and helpful links

General Publications

• Laffont I, Froger J, Jourdan C, Bakhti K, van Dokkum LEH, Gouaich A, Bonnin HY, Armingaud P, Jaussent A, Picot MC, Le Bars E, Dupeyron A, Arquizan C, Gelis A, Mottet D. Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. Ann Phys Rehabil Med. 2020 May;63(3):173-180. doi: 10.1016/j.rehab.2019.10.009. Epub 2019 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2011
• Primary Completion (Actual): March 22, 2016
• Study Completion (Actual): July 12, 2016

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Upper arm; Occupational Therapy; Virtual reality; Video games; Motor function; Functional MRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 8642; 2010-A00596-33 (Other Identifier: ID RCB)