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

Primary Purpose

Stroke, Motor Disorders

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MindMotionPRO
Self-Directed Prescribed Exercises
Sponsored by
Mindmaze SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, Stroke, Neurorehabilitation, Upper-limb rehabilitation, Training games

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schön Klinik
  • Santa Maria della Misericordia Hospital
  • Queen Elisabeth University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MindMotionPRO

Self-Directed Prescribed Exercises

Arm Description

MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation

Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation

Outcomes

Primary Outcome Measures

Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods

Secondary Outcome Measures

Number of exercises performed
Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales
Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score
Change from Baseline in self-care ability measured by the Barthel index (BI)
Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY)
Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)
Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)
Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)
Motivation measured by the Intrinsic Motivation Index (IMI)

Full Information

First Posted
February 12, 2016
Last Updated
March 20, 2018
Sponsor
Mindmaze SA
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1. Study Identification

Unique Protocol Identification Number
NCT02688413
Brief Title
Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation
Acronym
MOVE-Rehab
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment, evolution of investigational device, differences in healthcare models affecting trial
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mindmaze SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Motor Disorders
Keywords
Virtual reality, Stroke, Neurorehabilitation, Upper-limb rehabilitation, Training games

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MindMotionPRO
Arm Type
Experimental
Arm Description
MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation
Arm Title
Self-Directed Prescribed Exercises
Arm Type
Active Comparator
Arm Description
Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation
Intervention Type
Device
Intervention Name(s)
MindMotionPRO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-Directed Prescribed Exercises
Other Intervention Name(s)
Graded Repetitive Arm Supplementary Program (GRASP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Number of exercises performed
Time Frame
4 weeks
Title
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
Title
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
Title
Change from Baseline in self-care ability measured by the Barthel index (BI)
Time Frame
baseline, 4 weeks, 16 weeks
Title
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
Title
Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)
Time Frame
baseline, 4 weeks, 16 weeks
Title
Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)
Time Frame
baseline, 4 weeks, 16 weeks
Title
Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)
Time Frame
baseline, 4 weeks, 16 weeks
Title
Motivation measured by the Intrinsic Motivation Index (IMI)
Time Frame
1 week and 4 weeks
Other Pre-specified Outcome Measures:
Title
Resource utilization: time spent administrating rehabilitation exercises
Description
therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises
Time Frame
4 weeks
Title
Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC)
Description
muscle strength for shoulder elevation, elbow flexion/extension, forearm pronation/supination and wrist extension/flexion
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valeria Caso, MD
Organizational Affiliation
Azienda Ospedale Santa Maria della Misericordia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schön Klinik
City
Bad Aibling
ZIP/Postal Code
83043
Country
Germany
Facility Name
Santa Maria della Misericordia Hospital
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
Facility Name
Queen Elisabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation

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