Clinical trial NCT02688413: Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation
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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Motor Disorders
Keywords: Virtual reality
Stroke
Neurorehabilitation
Upper-limb rehabilitation
Training games
Lead sponsor: Mindmaze SA
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of exercises performed
timeFrame: 4 weeks
measure: Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in self-care ability measured by the Barthel index (BI)
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY)
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)
timeFrame: baseline, 4 weeks, 16 weeks
measure: Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)
timeFrame: baseline, 4 weeks, 16 weeks
measure: Motivation measured by the Intrinsic Motivation Index (IMI)
timeFrame: 1 week and 4 weeks
Other outcomes:
measure: Resource utilization: time spent administrating rehabilitation exercises
timeFrame: 4 weeks
measure: Change from Baseline in upper extremity muscle strength measured by the Medical research Council Scale (MRC)
timeFrame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 16 weeks
Locations:
city: Bad Aibling
country: Germany
facility: Schön Klinik
city: Perugia
country: Italy
facility: Santa Maria della Misericordia Hospital
state: Umbria
city: Glasgow
country: United Kingdom
facility: Queen Elisabeth University Hospital
Study officials:
affiliation: Azienda Ospedale Santa Maria della Misericordia, Italy
name: Valeria Caso, MD
role: PRINCIPAL_INVESTIGATOR
References: