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Clinical Trials/NCT03094650
NCT03094650
Completed
N/A

The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors

Mindmaze SA1 site in 1 country10 target enrollmentFebruary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Stroke
Sponsor
Mindmaze SA
Enrollment
10
Locations
1
Primary Endpoint
Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
November 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

Time Frame: 5 weeks

Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)

Training intensity: number of goal-directed movements per minute of effective training time.

Time Frame: 5 weeks

Training intensity: number of goal-directed movements per minute of effective training time.

Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Time Frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Secondary Outcomes

  • Change in Modified Medical Research Council Scale (mMRCS)(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
  • Change in Functional Independence Measure (FIM)(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
  • Change in Visual Analog Scale (VAS) for Pain(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
  • Change in kinematic metrics/goniometry (active range of motion).(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
  • Safety and Acceptance of Technology assessed with a questionnaire(5 weeks)

Study Sites (1)

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