Clinical trial NCT05215522: Tele BCI-FES for Upper -Limb Stoke Rehabilitation
Official title: Upper Limb Telerehabilitation Using Brain -Controlled Functional Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Brain-computer interface
functional electrical stimulation
Tele-rehabilitation
stroke rehabilitation
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Medical Research Council
First posted: 2022-01-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES
timeFrame: within 10 minutes after experimental session
measure: Evaluate the usability and acceptability of the proposed system based on the number of participants completing each TeleBCI-FES intervention session
timeFrame: through study completion, an average of 5 weeks
measure: Recruitment rate
timeFrame: Pre-intervention
Secondary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Pre-intervention and up to 5 weeks
measure: Action Research Arm Test
timeFrame: Pre-intervention and up to 5 weeks
measure: Modified Ashworth Scale
timeFrame: Pre-intervention and up to 5 weeks
measure: Medical Research Council grading
timeFrame: Pre-intervention and up to 5 weeks
measure: Leeds Arm Spasticity Scale-reference
timeFrame: Baseline and up to 5 weeks
measure: Numerical rating Scale (NRS)
timeFrame: Pre-intervention and up to 5 weeks
measure: Pittsburgh Participation in Rehabilitation scale
timeFrame: within 10 minutes after experimental session
measure: European Quality of List 5D-5L (EQ-5D-5L):
timeFrame: Pre-intervention and .up to 5 weeks
Other outcomes:
measure: Interviews
timeFrame: within 10 minutes after experimental session
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Mahnaz Arvaneh, PhD
role: PRINCIPAL_INVESTIGATOR
References: