Clinical trial NCT01554449: Upper Arm Reahabilitation After Stroke and Video Game
Official title: Effect of Early Upper Arm Rehabilitation After Stroke Using Adaptative Video Games
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebro-vascular Accident
Upper Arm Disability
Reaching
Grasping
Keywords: Stroke
Upper arm
Rehabilitation
Motor function
Video games
Virtual reality
Occupational Therapy
Functional MRI
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Efficacy assessment of the serious game on the recovery of the upper limb
timeFrame: at 6 weeks
Secondary outcomes:
measure: Fugl Meyer Score between both groups
timeFrame: at 6 Months
measure: Box and Block Test assessment between both groups
timeFrame: at 6 Weeks and 6 Months
measure: Wolf Motor Function Test assessment between both groups.
timeFrame: at 6 weeks and at 6 months
measure: Motor Activity Log assessment between both groups
timeFrame: at 6 weeks and at 6 months
measure: Barthel Index and SF-36
timeFrame: at 6 weeks and at 6 months
measure: Functional MRI Assessment between controls and patients
timeFrame: at baseline and at 6 weeks
measure: Nine Hole Peg test assessment between both groups
timeFrame: at 6 weeks and at 6 months
measure: tensor diffusion analysis between controls and patients
timeFrame: at 6 weeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier
Study officials:
affiliation: CHRU de Montpellier
name: Laffont Isabelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.