Upper Arm Reahabilitation After Stroke and Video Game

Stroke Clinical Trial

— MARGAUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554449
• Other study ID #: 8642
• Secondary ID: 2010-A00596-33
• Status: Completed
• Phase: N/A
• Start date: September 12, 2011
• Est. completion date: July 12, 2016

Study information

• Verified date: May 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 12, 2016
• Est. primary completion date: March 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebro-vascular Accident
• Grasping
• Reaching
• Stroke
• Upper Arm Disability

Intervention

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
• functional MRI
the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.

Locations

Country	Name	City	State
France	CHRU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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