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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02688413
• Date of registration: 12/02/2016
• Prospective Registration: Yes
• Primary sponsor: Mindmaze SA
• Public title: Study Evaluating the MindMotionPRO for Early Post-stroke Upper-limb Rehabilitation MOVE-Rehab
• Scientific 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
• Date of first enrolment: August 2016
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02688413
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany, Italy, Switzerland, United Kingdom

Contacts

• Name: Valeria Caso, MD
• Affiliation: Azienda Ospedale Santa Maria della Misericordia, Italy

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Motor Disorders

Intervention(s)

Device: MindMotionPRO

Other: Self-Directed Prescribed Exercises

Primary Outcome(s)

Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods [Time Frame: 4 weeks]

Secondary Outcome(s)

Motivation measured by the Intrinsic Motivation Index (IMI) [Time Frame: 1 week and 4 weeks]

Number of exercises performed [Time Frame: 4 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]

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]

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]

Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS) [Time Frame: 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]

Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL) [Time Frame: 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]

Secondary ID(s)

MindMaze-2016-RCT01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors