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

NCT ID: NCT02688413

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-02-28

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.

Conditions

Stroke; Motor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MindMotionPRO

MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation

Group Type: EXPERIMENTAL

MindMotionPRO

Intervention Type: DEVICE

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 Exercises

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

Group Type: ACTIVE_COMPARATOR

Self-Directed Prescribed Exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Graded Repetitive Arm Supplementary Program (GRASP)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mindmaze SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valeria Caso, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedale Santa Maria della Misericordia, Italy

Locations

Schön Klinik

Bad Aibling, , Germany

Santa Maria della Misericordia Hospital

Perugia, Umbria, Italy

Queen Elisabeth University Hospital

Glasgow, , United Kingdom

Countries

Germany; Italy; United Kingdom

Other Identifiers

MindMaze-2016-RCT01

Identifier Type: -

Identifier Source: org_study_id