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Upper Arm Reahabilitation After Stroke and Video Game (MARGAUT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01554449
First received: March 7, 2012
Last updated: March 12, 2012
Last verified: March 2012

March 7, 2012
March 12, 2012
September 2011
September 2013   (final data collection date for primary outcome measure)
Efficacy assessment of the serious game on the recovery of the upper limb [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
Difference in increase of the Upper Arm Fugl Meyer Score (max: 66) between both groups, at the end of the rehabilitation program (week 6)
Same as current
Complete list of historical versions of study NCT01554449 on ClinicalTrials.gov Archive Site
  • Fugl Meyer Score between both groups [ Time Frame: at 6 Months ] [ Designated as safety issue: No ]
    Difference in increase of the Upper Arm Fugl Meyer Score (max: 66) between both groups, at the end of the study(6 months)
  • Box and Block Test assessment between both groups [ Time Frame: at 6 Weeks and 6 Months ] [ Designated as safety issue: No ]
    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.
  • Wolf Motor Function Test assessment between both groups. [ Time Frame: at 6 weeks and at 6 months ] [ Designated as safety issue: No ]
    To assess the motor capacity by the Wolf motor funtion at 6 Weeks and after 6 Months.
  • Motor Activity Log assessment between both groups [ Time Frame: at 6 weeks and at 6 months ] [ Designated as safety issue: No ]
    This test assess the frequency of use and the quality of the movement.
  • Barthel Index and SF-36 [ Time Frame: at 6 weeks and at 6 months ] [ Designated as safety issue: No ]
    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.
  • Functional MRI Assessment between controls and patients [ Time Frame: at baseline and at 6 weeks ] [ Designated as safety issue: No ]
    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.
  • Nine Hole Peg test assessment between both groups [ Time Frame: at 6 weeks and at 6 months ] [ Designated as safety issue: No ]
    To assess the efficacy of Serious Game on manual dexterity on the duration of Nine Hole Peg test.
  • tensor diffusion analysis between controls and patients [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Upper Arm Reahabilitation After Stroke and Video Game
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Stroke
  • Cerebro-vascular Accident
  • Upper Arm Disability
  • Reaching
  • Grasping
  • 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.
  • Experimental: Serious game
    In this group, patients will have a session of conventional retraining with a serious game retraining.
    Interventions:
    • Procedure: serious game reeducation
    • Procedure: functional MRI
  • 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
    Interventions:
    • Procedure: serious game reeducation
    • Procedure: functional MRI
  • Placebo Comparator: controls
    For the neurologic assessments, patients are compared to healthy patient (without stroke)
    Intervention: Procedure: functional MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
March 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: Laffont Isabelle, MD, PhD 0467338717 i-laffont@chu-montpellier.fr
France
 
NCT01554449
8642, 2010-A00596-33
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Laffont Isabelle, MD, PhD CHRU de Montpellier
University Hospital, Montpellier
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP