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

NCT02688413 | Terminated

• 1 other identifier: MindMaze-2016-RCT01
• Study Type: interventional
• Target: 9
• Locations: 3 countries
• Sites: 3

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.

Conditions

Stroke; Motor Disorders

Keywords

Virtual reality; Stroke; Neurorehabilitation; Upper-limb rehabilitation; Training games

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (9)

• Number of exercises performed

  4 weeks

• Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales

  baseline, 4 weeks, 16 weeks

• Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score

  baseline, 4 weeks, 16 weeks

• Change from Baseline in self-care ability measured by the Barthel index (BI)

  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)

  baseline, 4 weeks, 16 weeks

Other Outcomes (2)

• Resource utilization: time spent administrating rehabilitation exercises

  4 weeks

• Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC)

  Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks

Study Arms (2)

MindMotionPRO

EXPERIMENTAL

MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation

Device: MindMotionPRO

Self-Directed Prescribed Exercises

ACTIVE COMPARATOR

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

Other: Self-Directed Prescribed Exercises

Interventions

MindMotionPRO 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.

MindMotionPRO

Self-Directed Prescribed Exercises 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.

Also known as: Graded Repetitive Arm Supplementary Program (GRASP)

Self-Directed Prescribed Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female \> 18 years old
• First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mindmaze SA: lead

Study Sites (3)

Schön Klinik

Bad Aibling, 83043, Germany

Location

Santa Maria della Misericordia Hospital

Perugia, Umbria, 06129, Italy

Location

Queen Elisabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Valeria Caso, MD

  Azienda Ospedale Santa Maria della Misericordia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 23, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Locations

GB (1); DE (1); IT (1)