StrokeMOVE-RehabNCT02688413
Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation
A study testing MindMotionPRO and Self-Directed Prescribed Exercises in people with Stroke and Motor Disorders, run by Mindmaze SA at 3 sites in 3 countries.
Trial summary
Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Motor Disorders
- What is being tested?
- MindMotionPRO and Self-Directed Prescribed Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2016to Feb 2018
- 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
- Male/female > 18 years old
- First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness
- 1 to 6 weeks post-stroke
- Able to give informed consent
- Not participating any other intervention studies
- Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the range of 20 to 40 out of 66
- Stroke severity with NIHSS score between 5 (mild) and 14 (moderate) out of 42
- The participant is expected to remain available (geographically stable) for 4 months after enrolment.
Who cannot join
- Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
- Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation dose
- History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
- Mild to severe cognitive impairment (Mini mental state exam (MMSE) score < 24/30)
- Depression (Hospital Anxiety and Depression Scale > 8/21)
- Moderate to severe hemispatial neglect compromising the ability to take part to the study, as determined by the Bells tests (> 6 errors)
- Brain stem stroke
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Queen Elisabeth University Hospital
Glasgow, G51 4TF
About this study
Official title: Randomized Parallel-group Study Evaluating the Effectiveness and Cost-effectiveness of the Co-administration of MindMotionPRO Plus Standard Practice Versus Standard Practice in Early Post-stroke Upper-limb Rehabilitation
Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.
Read the detailed description
The goal of the study is to show that MindMotionPRO is a tool that allows a patient to increase the amount of rehabilitation therapy performed. This study will measure the rehabilitation dose, as measured by the duration of the rehabilitation session and the number of exercises performed by the patient. The study hypothesis is that patients in the MindMotionPRO group will spend more time performing rehabilitation exercises than in the Self-Directed Prescribed exercises group. The effectiveness of the MindMotionPRO versus Self-Directed Prescribed Exercises will also be measured, based on the change in rehabilitation performance measures. The cost-effectiveness will be measured by the resource utilization, as defined by the time spent by the therapist providing the rehabilitation session.
- Conditions
- Stroke, Motor Disorders
- Being tested
- MindMotionPRO, Self-Directed Prescribed Exercises
- Keywords
- Virtual reality, Stroke, Neurorehabilitation, Upper-limb rehabilitation, Training games
- Medical subject headings
- Stroke, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMotionPRODevice
The MindMotionPRO, a certified device for medical use, is a virtual reality based system to train upper limb activities in a game scenario. The participant will receive 5 exercises sessions with the MindMotionPRO per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
Self-Directed Prescribed ExercisesOther
Also called Graded Repetitive Arm Supplementary Program (GRASP)
GRASP is an arm and hand exercise program for stroke patients, designed to supplement standard rehabilitation therapies. The participant will receive 5 GRASP exercises sessions per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
| Study group | Role | What they receive |
|---|---|---|
| MindMotionPRO | Experimental | MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation Receives: Device: MindMotionPRO |
| Self-Directed Prescribed Exercises | Active comparator | Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation Receives: Other: Self-Directed Prescribed Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
Measured: 4 weeks
Secondary outcomes (9)
Number of exercises performed
Measured: 4 weeks
Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in self-care ability measured by the Barthel index (BI)
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY)
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)
Measured: baseline, 4 weeks, 16 weeks
Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)
Measured: baseline, 4 weeks, 16 weeks
Motivation measured by the Intrinsic Motivation Index (IMI)
Measured: 1 week and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionFeb 2018
Why it stopped: slow recruitment, evolution of investigational device, differences in healthcare models affecting trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mindmaze SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valeria Caso, MD, Principal investigator, Azienda Ospedale Santa Maria della Misericordia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688413
- Sponsor's protocol ID
- MindMaze-2016-RCT01
- Acronym
- MOVE-Rehab
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Parallel-group Study Evaluating the Effectiveness and Cost-effectiveness of the Co-administration of MindMotionPRO Plus Standard Practice Versus Standard Practice in Early Post-stroke Upper-limb Rehabilitation
- ClinicalTrials.gov ID
- NCT02688413
- Acronym / sponsor ID
- MOVE-Rehab / MindMaze-2016-RCT01
- Conditions
- Stroke, Motor Disorders
- Keywords
- Virtual reality, Stroke, Neurorehabilitation, Upper-limb rehabilitation, Training games
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment, evolution of investigational device, differences in healthcare models affecting trial
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mindmaze SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 23 Feb 2016 (estimated)
- 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.
Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.
Detailed description
The goal of the study is to show that MindMotionPRO is a tool that allows a patient to increase the amount of rehabilitation therapy performed. This study will measure the rehabilitation dose, as measured by the duration of the rehabilitation session and the number of exercises performed by the patient. The study hypothesis is that patients in the MindMotionPRO group will spend more time performing rehabilitation exercises than in the Self-Directed Prescribed exercises group. The effectiveness of the MindMotionPRO versus Self-Directed Prescribed Exercises will also be measured, based on the change in rehabilitation performance measures. The cost-effectiveness will be measured by the resource utilization, as defined by the time spent by the therapist providing the rehabilitation session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MindMotionPRO | Experimental | Device: MindMotionPROMindMotionPRO exercises in addition to standard practice for upper limb rehabilitation |
| Self-Directed Prescribed Exercises | Active comparator | Other: Self-Directed Prescribed ExercisesSelf-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male/female > 18 years old
- First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness
- 1 to 6 weeks post-stroke
- Able to give informed consent
- Not participating any other intervention studies
Key exclusion criteria (7 listed)
- Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
- Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation dose
- History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
- Mild to severe cognitive impairment (Mini mental state exam (MMSE) score < 24/30)
- Depression (Hospital Anxiety and Depression Scale > 8/21)
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 |
|---|---|---|
| MindMotionPROThe MindMotionPRO, a certified device for medical use, is a virtual reality based system to train upper limb activities in a game scenario. The participant will receive 5 exercises sessions with the MindMotionPRO per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week. | Device | MindMotionPRO |
| Self-Directed Prescribed ExercisesAlso: Graded Repetitive Arm Supplementary Program (GRASP)GRASP is an arm and hand exercise program for stroke patients, designed to supplement standard rehabilitation therapies. The participant will receive 5 GRASP exercises sessions per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week. | Other | Self-Directed Prescribed Exercises |
Primary outcome
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
Time frame: 4 weeks
9 secondary outcomes
Number of exercises performed
Time frame: 4 weeks
Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in self-care ability measured by the Barthel index (BI)
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY)
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)
Time frame: baseline, 4 weeks, 16 weeks
Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)
Time frame: baseline, 4 weeks, 16 weeks
Motivation measured by the Intrinsic Motivation Index (IMI)
Time frame: 1 week and 4 weeks
Results and safety
The study was stopped early (reason given: slow recruitment, evolution of investigational device, differences in healthcare models affecting trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Valeria Caso, MD principal investigator
Azienda Ospedale Santa Maria della Misericordia, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindMotionPRO and Self-Directed Prescribed Exercises in people with Stroke and Motor Disorders, run by Mindmaze SA at 3 sites in 3 countries.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, United Kingdom. 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 was stopped early (reason given: slow recruitment, evolution of investigational device, differences in healthcare models affecting trial). Results are not available in the source record.
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 as measured by the duration of the rehabilitation session without planned rest periods (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.