NCT03094650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

March 14, 2017

Last Update Submit

March 23, 2017

Conditions

Chronic StrokeMotor Disorders

Keywords

strokeneurorehabilitationvirtual realityrehabilitation dosemotor rehabilitation

Outcome Measures

Primary Outcomes (3)

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

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

    5 weeks

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

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

    5 weeks

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

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

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

Secondary Outcomes (5)

  • Change in Functional Independence Measure (FIM)

    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)

  • Change in Modified Medical Research Council Scale (mMRCS)

    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)

  • Safety and Acceptance of Technology assessed with a questionnaire

    5 weeks

Study Arms (1)

MindMotion PRO

EXPERIMENTAL

The training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device.

Device: MindMotion PRO

Interventions

MindMotion PRODEVICE

Patients will receive five weeks of therapy with 2 sessions (minimum) per week lasting for 45-60 minutes each minimum. The training sessions are based on the MindMotion PRO's virtual reality exercises.

MindMotion PRO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years and older
  • First ever stroke

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation

Sion, Valais, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 29149855DERIVED

MeSH Terms

Conditions

Motor DisordersStroke

Condition Hierarchy (Ancestors)

Mental DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 29, 2017

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

CH(1)