Status:
NOT_YET_RECRUITING
ANIMATOR - RehUP BCI Controlled Robotic Therapy vs. an Attention-based Control
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
VIBRAINT Inc.
Conditions:
Chronic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 interve...
Detailed Description
There is a large population of Canadians with chronic stroke and severely impaired upper limbs. Consultation with this population reveals individuals who are looking for treatment to improve their abi...
Eligibility Criteria
Inclusion
- Stroke survivors, ≥ 6 months post-stroke with severe arm impairment.
- 18 years of age of older
- Adequate language skills to be able to follow instructions
- FM-UE score 30 or less at study entry (i.e., severe arm impairment and would likely not use the stroke-affected arm in daily activities)
- Modified Ashworth Score ≦ 2
- Visual acuity 20/50 corrected (both eyes)
Exclusion
- Potential participants will be excluded if they do not meet the requirements above, or:
- have neurologic history in addition to stroke (injury or disease), eg. TBI, MS, dementia
- enrollment in concurrent interventional trial
- major co-morbid illness making study completion unlikely
- contraindication to MRI (such as pacemaker, pregnancy, etc).
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06538506
Start Date
August 1 2024
End Date
March 1 2027
Last Update
August 9 2024
Active Locations (1)
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1
Foothills Hospital
Calgary, Alberta, Canada, T2N2T9