Clinical trial NCT03094650: Immersive Virtual Reality for Stroke Motor Rehabilitation
Official title: The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Motor Disorders
Keywords: stroke
neurorehabilitation
virtual reality
rehabilitation dose
motor rehabilitation
Lead sponsor: Mindmaze SA
Sponsor class: INDUSTRY
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
name: Clinique Romande de Readaptation
First posted: 2017-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic minor-to-moderate (0\<NIHSS\<16) stroke with hemiparesis and experiencing arm motor difficulties
* At least 6 months after stroke incident
* Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension
* 18 years and older
* First ever stroke

Exclusion Criteria:

* Participating in another movement treatment study at the time of the present study
* Severe cognitive impairment (Mini Mental Status Examination score \< 18 points)
* Orthopedic impairment or visual disorders limiting the treatment
* Unable to give informed consent form
* Risk of epileptic seizures

Primary outcomes:
measure: Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
timeFrame: 5 weeks
measure: Training intensity: number of goal-directed movements per minute of effective training time.
timeFrame: 5 weeks
measure: Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
timeFrame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary outcomes:
measure: Change in Functional Independence Measure (FIM)
timeFrame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
measure: Change in kinematic metrics/goniometry (active range of motion).
timeFrame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
measure: Change in Modified Medical Research Council Scale (mMRCS)
timeFrame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
measure: Safety and Acceptance of Technology assessed with a questionnaire
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation
state: Valais
Study officials:
References:
citation: Perez-Marcos D, Chevalley O, Schmidlin T, Garipelli G, Serino A, Vuadens P, Tadi T, Blanke O, Millan JDR. Increasing upper limb training intensity in chronic stroke using embodied virtual reality: a pilot study. J Neuroeng Rehabil. 2017 Nov 17;14(1):119. doi: 10.1186/s12984-017-0328-9.