Tele BCI-FES for Upper -Limb Stoke Rehabilitation

University of Sheffield13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

The BCI-FES InterventionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sheffield Teaching Hospitals

Sheffield, South Yorkshire, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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