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

March 20, 2018 updated by: Mindmaze SA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Aibling, Germany, 83043
        • Schon Klinik
  • Italy
    • Umbria
      • Perugia, Umbria, Italy, 06129
        • Santa Maria della Misericordia Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elisabeth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Graded Repetitive Arm Supplementary Program (GRASP)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of exercises performed
Time Frame: 4 weeks
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
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
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
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
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
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
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
baseline, 4 weeks, 16 weeks
Motivation measured by the Intrinsic Motivation Index (IMI)
Time Frame: 1 week and 4 weeks
1 week and 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resource utilization: time spent administrating rehabilitation exercises
Time Frame: 4 weeks
therapist (physiotherapist or other medical staff) time spent administrating rehabilitation exercises
4 weeks
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
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mindmaze SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valeria Caso, MD, Azienda Ospedale Santa Maria della Misericordia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MindMaze-2016-RCT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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