Upper Arm Reahabilitation After Stroke and Video Game "MARGAUT"

Recruiting

Phase 3 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Serious game reeducation Procedure
    Intervention Desc: It's a daily session (45 minutes) of reeducation by serious game (kinect) compared to a daily session (45 minutes) of conventional reeducation
    ARM 1: Kind: Experimental
    Label: Serious game
    Description: In this group, patients will have a session of conventional retraining with a serious game retraining.
    ARM 2: Kind: Experimental
    Label: control patients
    Description: 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
  • Functional MRI Procedure
    Intervention Desc: the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.
    ARM 1: Kind: Experimental
    Label: Serious game
    Description: In this group, patients will have a session of conventional retraining with a serious game retraining.
    ARM 2: Kind: Experimental
    Label: control patients
    Description: 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
    ARM 3: Kind: Experimental
    Label: controls
    Description: For the neurologic assessments, patients are compared to healthy patient (without stroke)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Efficacy assessment of the serious game on the recovery of the upper limb at 6 weeks No
Secondary Fugl Meyer Score between both groups at 6 Months No
Secondary Box and Block Test assessment between both groups at 6 Weeks and 6 Months No
Secondary Wolf Motor Function Test assessment between both groups. at 6 weeks and at 6 months No
Secondary Motor Activity Log assessment between both groups at 6 weeks and at 6 months No
Secondary Barthel Index and SF-36 at 6 weeks and at 6 months No
Secondary Functional MRI Assessment between controls and patients at baseline and at 6 weeks No
Secondary Nine Hole Peg test assessment between both groups at 6 weeks and at 6 months No
Secondary tensor diffusion analysis between controls and patients at 6 weeks No

Sponsors