ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control
NCT Number: NCT06538506
Acronym: ANIMATOR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Stroke
Interventions: DEVICE: RehUp BCI Intervention|OTHER: Control Therapy
Sponsor: University of Calgary
Collaborators: VIBRAINT Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-03
Locations: Foothills Hospital, Calgary, Alberta, T2N2T9, Canada

Summary:
ANIMATOR aims to examine how BCI therapy vs. attention based control therapy can be used to treat people in the chronic phase of stroke with moderate to severe upper extremity impairment. This interventional trial has two phases: Pilot (10 consecutive days of intervention) and a Randomized Phase (24 sessions over 8 weeks).

Primary Outcome Measures: Fugl-Meyer Upper Extremity (FM-UE), Change in Fugl-Meyer Upper Extremity (FM-UE) from measurement at baseline. The FM-UE is the most widely used outcome measure for upper limb stroke recovery studies.

The FM-UE is scored on a scale from 0 to 66, where 66 points indicates unimpaired motor function., Baseline, 4weeks, 8 weeks, 16 weeks
Secondary Outcome Measures: Action Research Arm Test (ARAT), Change in Action Research Arm Test (ARAT) from measurement at baseline. The ARAT will provide complimentary data on limb impairment.

The ARAT is scored on a scale from 0 to 57 points, where 57 points indicates unimpaired motor function., Baseline, 4 weeks, 8 weeks, 16 weeks|Modified Ashworth Scale (MAS), Change in Modified Ashworth Scale (MAS) from measurement at baseline. The MAS is used to assess spasticity.

The MAS is scored on a 6 point scale \[0, 1, 1+, 2, 3, 4\]. 0 indicates no increase in tone. 4 indicates the limb is rigid in flexion or extension., Baseline, 4 weeks, 8 weeks, 16 weeks|Patient Health Questionnaire - Module 9 (PHQ-9), Change in Patient Health Questionnaire - Module 9 (PHQ-9) from measurement at baseline. The PHQ-9 is used to screen for depression.

The PHQ-9 is a 10 question screening tool where nine of the ten items are scored on a scale from 0 to 3. The tenth item grades how difficult the first nine items make the participant's day-to-day life. A lower score indicates a lower likelihood and/or severity of depression., Baseline, 4 weeks, 8 weeks, 16 weeks|EQ-5D (EuroQuol Measure of Health Status, Version 5D), Change in EQ-5D (EuroQuol Measure of Health Status, Version 5D) from measurement at baseline. The EQ-5D is used to measure quality of life.

The EQ-5D scores fives areas of health on a scale of 1-5, where 1 indicates no problems and 5 indicates extreme problems., Baseline, 4 weeks, 8 weeks, 16 weeks
Other Outcome Measures: National Institute of Health Stroke Scale (NIHSS), Change in National Institute of Health Stroke Scale (NIHSS) from measurement at baseline. The NIHSS is used to measure stroke severity.

The NIHSS evaluates 11 items on 3, 4, or 5 point scales depending on level of detail. Higher scores indicate more severe symptoms of stroke., Baseline, 4 weeks, 8 weeks, 16 weeks|Modified Rankin Scale (mRS), Change in Modified Rankin Scale (mRS) from measurement at baseline. The mRS is used to measure the degree of functional neurological disability after stroke.

The mRS is a 7 point scale (0-6) where 6 indicates that the patient has died and 0 indicates the patient has no symptoms of disability., Baseline, 4 weeks, 8 weeks, 16 weeks