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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

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.

Condition or disease Intervention/treatment Phase
Stroke Motor Disorders Device: MindMotionPRO Other: Self-Directed Prescribed Exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MindMotionPRO
MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation
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.

Active Comparator: Self-Directed Prescribed Exercises
Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation
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)




Primary Outcome Measures :
  1. Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Number of exercises performed [ Time Frame: 4 weeks ]
  2. 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 ]
  3. 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 ]
  4. Change from Baseline in self-care ability measured by the Barthel index (BI) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  5. 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 ]
  6. Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  7. Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  8. Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL) [ Time Frame: baseline, 4 weeks, 16 weeks ]
  9. Motivation measured by the Intrinsic Motivation Index (IMI) [ Time Frame: 1 week and 4 weeks ]

Other Outcome Measures:
  1. Resource utilization: time spent administrating rehabilitation exercises [ Time Frame: 4 weeks ]
    therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688413


Locations
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Germany
Schön Klinik
Bad Aibling, Germany, 83043
Italy
Santa Maria della Misericordia Hospital
Perugia, Umbria, Italy, 06129
United Kingdom
Queen Elisabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Sponsors and Collaborators
Mindmaze SA
Investigators
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Principal Investigator: Valeria Caso, MD Azienda Ospedale Santa Maria della Misericordia, Italy

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Responsible Party: Mindmaze SA
ClinicalTrials.gov Identifier: NCT02688413     History of Changes
Other Study ID Numbers: MindMaze-2016-RCT01
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mindmaze SA:
Virtual reality
Stroke
Neurorehabilitation
Upper-limb rehabilitation
Training games

Additional relevant MeSH terms:
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Stroke
Motor Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mental Disorders