Chronic StrokeNCT03094650
Immersive Virtual Reality for Stroke Motor Rehabilitation
A study testing MindMotion PRO in people with Chronic Stroke and Motor Disorders, run by Mindmaze SA at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke, Motor Disorders
- What is being tested?
- MindMotion PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Neuroprosthetics-Valais (EPFL) at Clinique Romande de Réadaptation
Sion, Valais
About this study
Official title: The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors
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.
- Conditions
- Chronic Stroke, Motor Disorders
- Being tested
- MindMotion PRO
- Keywords
- stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation
- Medical subject headings
- Motor Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MindMotion PRO | Experimental | The training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device. Receives: Device: MindMotion PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Secondary outcomes (5)
Change in Functional Independence Measure (FIM)
Measured: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in kinematic metrics/goniometry (active range of motion).
Measured: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Modified Medical Research Council Scale (mMRCS)
Measured: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Visual Analog Scale (VAS) for Pain
Measured: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Safety and Acceptance of Technology assessed with a questionnaire
Participants will answer a questionnaire to evaluate following aspects:
- Tolerance to VR intervention
- Adverse event monitoring
- Self-evaluation
- Acceptance of technology
- Motivation
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startFeb 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mindmaze SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094650
- Sponsor's protocol ID
- MindMaze-2015-CT01
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29149855
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors
- ClinicalTrials.gov ID
- NCT03094650
- Acronym / sponsor ID
- MindMaze-2015-CT01
- Conditions
- Chronic Stroke, Motor Disorders
- Keywords
- stroke, neurorehabilitation, virtual reality, rehabilitation dose, motor rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mindmaze SAIndustry (pharma, biotech, devices)
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MindMotion PRO | Experimental | Device: MindMotion PROThe training sessions consist of virtual reality based rehabilitation exercises using the MindMotion PRO device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindMotion PROPatients 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. | Device | MindMotion PRO |
Primary outcome
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)
5 secondary outcomes
Change in Functional Independence Measure (FIM)
Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in kinematic metrics/goniometry (active range of motion).
Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Modified Medical Research Council Scale (mMRCS)
Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Change in Visual Analog Scale (VAS) for Pain
Time frame: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Safety and Acceptance of Technology assessed with a questionnaire
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 29149855Perez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindMotion PRO in people with Chronic Stroke and Motor Disorders, run by Mindmaze SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task) (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.