Tele BCI-FES for Upper -Limb Stoke Rehabilitation

Upper Limb Telerehabilitation Using Brain -Controlled Functional Electrical Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: The BCI-FES Intervention

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AT
      • Sheffield Teaching Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The BCI-FES Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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)	through study completion, an average of 5 weeks
Recruitment rate	To measure the acceptability of the proposed rehabilitation	Pre-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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).	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)	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)	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.	Pre-intervention and .up to 5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interviews	A qualitative assessment of the effectiveness and acceptability of treatment for participants.	within 10 minutes after experimental session

Collaborators and Investigators

• Sponsor: University of Sheffield
• Collaborators: Medical Research Council; Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Mahnaz Arvaneh, PhD, University of Sheffield

Publications and helpful links

Helpful Links

• A website introducing our technology, and our team

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: functional electrical stimulation; stroke rehabilitation; Tele-rehabilitation; Brain-computer interface
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: USheffield1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No