Tele BCI-FES for Upper -Limb Stoke Rehabilitation

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: The BCI-FES Intervention

• Registration Number: NCT05215522
• Lead Sponsor: University of Sheffield

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 assess the participants acceptability of this new home-based rehabilitation.

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 arm will not move or will only move partly. The brain continues to produce electrical signals after stroke, but when the signals are weak the arm does not move. Brain-computer interface (BCI), is a method of utilising the brain signals to produce useful outputs via computers. One type of BCI is BCI Functional Electrical Stimulus (BCI-FES) which is a device that can detect these brain signals produced during the intention to move the weak arm after a stroke. It then uses these signals to trigger an electrical stimulator. The electrical stimulator then stimulates the muscles in the weak arm to produce the desired arm movement. Recent studies show that rehabilitation using this device has given better results when compared with conventional rehabilitation approaches. However, the BCI-FES devices currently available are bulky and participants need to come to the hospital or laboratory to receive the treatment. Our project aims to develop a BCI-FES device, called Tele BCI-FES that can be used at stroke participant's home. The investigators are using techniques like machine learning to make the Tele BCI-FES quick and simple to set up, easy to use and effective. This study aims to investigate if the proposed Tele BCI-FES device is a feasible and acceptable intervention for post-stroke rehabilitation.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-01-31
• Study Start: 2022-06-15
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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:

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. History of epilepsy
9. Pace maker or any other implanted devices
10. Pregnancy
11. Severe dystonia/spasm

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The BCI-FES Intervention	The BCI-FES Intervention	The BCI-FES device will be used by all participants.

Primary Outcome Measures

Name	Time	Method
Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES	within 10 minutes after experimental session	To evaluate whether the participants can effectively control FES using the developed remote BCI system (Success: the BCI accuracy of more than 70% in at least 7 out of 9 sessions).
Recruitment rate	Pre-intervention	To measure the acceptability of the proposed rehabilitation
Evaluate the usability and acceptability of the proposed system based on the number of participants completing each TeleBCI-FES intervention session	through study completion, an average of 5 weeks	Number of participants completing each TeleBCI-FES intervention session (Success: 7 participants completed 8 or more of 12 TeleBCI-FES sessions)

Secondary Outcome Measures

Name	Time	Method
Modified Ashworth Scale	Pre-intervention and up to 5 weeks	This looks at elbow and wrist flexors on predefined scale. The scale ranges from 0 to 4 (worst).
Leeds Arm Spasticity Scale-reference	Baseline and up to 5 weeks	It is a measure of passive arm function, suitable for participants with spasticity and little or no active movement of the upper extremity. The score ranges from 0 (No difficulty) to 4 (Inability to perform the activity).
Numerical rating Scale (NRS)	Pre-intervention and up to 5 weeks	It requires the participant to rate their pain on a defined scale from 0 (no pain) to 10 (the worst pain)
European Quality of List 5D-5L (EQ-5D-5L):	Pre-intervention and .up to 5 weeks	It is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each level is assigned a rating based on the severity of the problems in that area (no problems walking, minor problems, moderate problems, severe problems, or inability to walk). The tool also includes an overall health scale, on which the participant chooses a number between 1 and 100 (best) to represent their health status.
Medical Research Council grading	Pre-intervention and up to 5 weeks	This looks at assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction) and takes around 10 minutes to complete.
Fugl-Meyer Assessment	Pre-intervention and up to 5 weeks	It is the most frequently used outcome scales to measure post stroke motor recovery of the upper extremity on a scale of 0-60 (best).
Action Research Arm Test	Pre-intervention and up to 5 weeks	It is a 19 item observational measure used to assess upper extremity performance on a scale of 0 - 57 (best).
Pittsburgh Participation in Rehabilitation scale	within 10 minutes after experimental session	It is a clinician-rated measure on a 6-point Likert-type scale that quantifies individuals' participation in their therapy sessions, ranging from 1 (None: participant refused the entire session) to 6 (Excellent: participant participated in all sessions)

Trial Locations

Locations (1)

Sheffield Teaching Hospitals; 🇬🇧 Sheffield, South Yorkshire, United Kingdom