Status:
COMPLETED
Tele BCI-FES for Upper -Limb Stoke Rehabilitation
Lead Sponsor:
University of Sheffield
Collaborating Sponsors:
Sheffield Teaching Hospitals NHS Foundation Trust
Medical Research Council
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to identify whether stroke survivors can intentionally modulate their brain signals for controlling an FES device to produce arm movements for home based rehabilitation. The study also ...
Detailed Description
Movements of different parts of the body, including the arm, start when the brain produces specific electrical signals. Sometimes after a stroke, even though the person intends to move the arm, the ar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 1\) Age 18 and above.
- (2) Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.
- (3) Arm weakness interfering with activities of daily living.
- (4) Fugl-Meyer score of upper limb\<45.
- (5) Caregiver is willing to assist with trial by helping to deliver intervention.
- (6) Cognitive and language abilities to understand and participate in the study protocol.
- (7) Can maintain sitting with or without support for 1 hour continuously.
- (8) Able to give consent and understand instructions.
- Exclusion criteria:
- Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
- Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
- Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse
- Inability to perform the baseline assessments;
- Severe tactile hypersensitivity;
- Participation in other, upper limb rehabilitation studies
- Within 12 weeks of receiving Botulinum toxin injections;
- History of epilepsy
- Pace maker or any other implanted devices
- Pregnancy
- Severe dystonia/spasm
Exclusion
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05215522
Start Date
June 15 2022
End Date
December 30 2022
Last Update
May 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sheffield Teaching Hospitals
Sheffield, South Yorkshire, United Kingdom, S5 7AT