sing brain signals to control functional electrical stimulation during the intention to move a weak arm after a stroke

Not Applicable

Completed

• Conditions: pper limb stroke rehabilitation; Not Applicable

• Registration Number: ISRCTN42991002
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-06
• Study Completion: 2022-12-01
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Age 18 years and above
2. Experienced an ischaemic or haemorrhagic stroke over 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

1. Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent
2. Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow
3. 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
4. Inability to perform the baseline assessments
5. Severe tactile hypersensitivity
6. Participation in other, upper limb rehabilitation studies
7. Within 12 weeks of receiving Botulinum toxin injections
8. Uncontrolled epilepsy
9. Pacemaker or any other implanted devices
10. Pregnancy
11. Severe dystonia/spasm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Brain-computer interface accuracy measured by percentage of successful movements achieved in each remote therapy session.<br>2. Safety assessed using Adverse Event questionnaire after each therapy session.<br>3. Improvement in upper extremity performance measured by Fugl-Meyer Assessment and Action Research Arm Test (ARAT) during the pre- and post- intervention.<br>4. Self-assessed health related, quality of life measured by European Quality of List 5D-5L (EQ-5D-5L) during the pre- and post- intervention.<br>5. Pain rate using Numerical Rating Scale (NRS) diary at the end of each therapy session

Secondary Outcome Measures

Name	Time	Method
1. The patient’s participation effort and motivation measured by PITTSBURGH rehabilitation participation scale after each therapy session.<br>2. Muscle strength measured by Medical Research Council (MRC) grade during the pre- and post- intervention.<br>3. Muscle tone assessment using the modified Ashworth scale during the pre- and post- intervention.<br><br>4. Acceptability of the proposed technology using qualitative interview and questionnaire at the end of each therapy session.