An interventional study of The BCI-FES Intervention in Stroke, sponsored by University of Sheffield. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University of Sheffield · Not applicable, Interventional, and Device feasibility
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.
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.
University of Sheffield is the lead sponsor of 74 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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:
The BCI-FES device will be used by all participants.
Device: The BCI-FES Intervention
To evaluate whether the participant can effectively control FES using the developed remote BCI system. Thus, participants will receive a three-week BCI-FES intervention at their home, including three sessions of intervention per week. Each session will last around 60 minutes, including 10 minutes of preparation, 40 minutes of intervention and 10 minutes interview on the user's experience with the device and any experienced side effects, if any.
Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES
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).
Time frame: within 10 minutes after experimental session
Evaluate the usability and acceptability of the proposed system based on the number of participants completing each TeleBCI-FES intervention session
Number of participants completing each TeleBCI-FES intervention session (Success: 7 participants completed 8 or more of 12 TeleBCI-FES sessions)
Time frame: through study completion, an average of 5 weeks
Recruitment rate
To measure the acceptability of the proposed rehabilitation
Time frame: Pre-intervention
Fugl-Meyer Assessment
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).
Time frame: Pre-intervention and up to 5 weeks
Action Research Arm Test
It is a 19 item observational measure used to assess upper extremity performance on a scale of 0 - 57 (best).
Time frame: Pre-intervention and up to 5 weeks
Modified Ashworth Scale
This looks at elbow and wrist flexors on predefined scale. The scale ranges from 0 to 4 (worst).
Time frame: Pre-intervention and up to 5 weeks
Medical Research Council grading
This looks at assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction) and takes around 10 minutes to complete.
Time frame: Pre-intervention and up to 5 weeks
Leeds Arm Spasticity Scale-reference
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).
Time frame: Baseline and up to 5 weeks
Numerical rating Scale (NRS)
It requires the participant to rate their pain on a defined scale from 0 (no pain) to 10 (the worst pain)
Time frame: Pre-intervention and up to 5 weeks
Pittsburgh Participation in Rehabilitation scale
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)
Time frame: within 10 minutes after experimental session
European Quality of List 5D-5L (EQ-5D-5L):
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.
Time frame: Pre-intervention and .up to 5 weeks
Interviews
A qualitative assessment of the effectiveness and acceptability of treatment for participants.
Time frame: within 10 minutes after experimental session
Plan to share: No — The participant's data will be "pseudo-anonymized" and no identifiable information will be maintained with the study data because the participant will be issued a unique study number. Paper copies of consent forms will be kept in locked cupboards at the University of Sheffield's Physiological Signals and Systems lab. Electronic data will be entered and saved immediately on a password-protected University server. After the study is completed, anonymised EEG data and questionnaire data will be preserved for fifteen years at the University of Sheffield archiving facility. The results of this study will be published in peer-reviewed journals. The findings will be presented in BCI and rehabilitation conferences, as well as patient-public involvement meetings. The participants will not be identifiable from any report or publication placed in the public domain.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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University of Sheffield