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Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation (MOVE-Rehab)

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ClinicalTrials.gov Identifier: NCT02688413
Recruitment Status : Terminated (slow recruitment, evolution of investigational device, differences in healthcare models affecting trial)
First Posted : February 23, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mindmaze SA

Tracking Information
First Submitted Date  ICMJE February 12, 2016
First Posted Date  ICMJE February 23, 2016
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2016)
  • Resource utilization: time spent administrating rehabilitation exercises [ Time Frame: 4 weeks ]
    therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises
  • Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC) [ Time Frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks ]
    muscle strength for shoulder elevation, elbow flexion/extension, forearm pronation/supination and wrist extension/flexion
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation
Official Title  ICMJE 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
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Motor Disorders
Intervention  ICMJE
  • Device: MindMotionPRO
    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.
  • Other: Self-Directed Prescribed Exercises
    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 Name: Graded Repetitive Arm Supplementary Program (GRASP)
Study Arms  ICMJE
  • Experimental: MindMotionPRO
    MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation
    Intervention: Device: MindMotionPRO
  • Active Comparator: Self-Directed Prescribed Exercises
    Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation
    Intervention: Other: Self-Directed Prescribed Exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2016)
42
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   United Kingdom
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT02688413
Other Study ID Numbers  ICMJE MindMaze-2016-RCT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mindmaze SA
Study Sponsor  ICMJE Mindmaze SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Valeria Caso, MD Azienda Ospedale Santa Maria della Misericordia, Italy
PRS Account Mindmaze SA
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP