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
  Purpose

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.


Condition Intervention Phase
Stroke
Cerebro-vascular Accident
Upper Arm Disability
Reaching
Grasping
Procedure: serious game reeducation
Procedure: functional MRI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Early Upper Arm Rehabilitation After Stroke Using Adaptative Video Games

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 62
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554449

Contacts
Contact: Laffont Isabelle, MD, PhD 0467338717 i-laffont@chu-montpellier.fr

Locations
France
CHRU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Laffont isabelle, MD, PhD    0467338717    i-laffont@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Laffont Isabelle, MD, PhD CHRU de Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01554449     History of Changes
Other Study ID Numbers: 8642, 2010-A00596-33
Study First Received: March 7, 2012
Last Updated: March 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Stroke
Upper arm
Rehabilitation
Motor function
Video games
Virtual reality
Occupational Therapy
Functional MRI

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014