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StrokeNCT05215522

Tele BCI-FES for Upper -Limb Stoke Rehabilitation

A study testing The BCI-FES Intervention in people with Stroke, run by University of Sheffield at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
The BCI-FES Intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited Kingdom
Study dates
15 Jun 2022to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Age 18 and above.
  • Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.
  • Arm weakness interfering with activities of daily living.
  • Fugl-Meyer score of upper limb<45.
  • Caregiver is willing to assist with trial by helping to deliver intervention.
  • Cognitive and language abilities to understand and participate in the study protocol.
  • Can maintain sitting with or without support for 1 hour continuously.
  • Able to give consent and understand instructions.

Who cannot join

  • Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
  • Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
  • 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
  • Inability to perform the baseline assessments;
  • Severe tactile hypersensitivity;
  • Participation in other, upper limb rehabilitation studies
Show all 11Show fewer
  • Within 12 weeks of receiving Botulinum toxin injections;
  • History of epilepsy
  • Pace maker or any other implanted devices
  • Pregnancy
  • Severe dystonia/spasm

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Sheffield Teaching Hospitals

    Sheffield, South Yorkshire, S5 7AT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
The BCI-FES Intervention
Keywords
Brain-computer interface, functional electrical stimulation, Tele-rehabilitation, stroke rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05215522
Study groupRoleWhat they receive
The BCI-FES InterventionExperimentalThe BCI-FES device will be used by all participants.
Receives: Device: The BCI-FES Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: within 10 minutes after experimental session

  2. 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)

    Measured: through study completion, an average of 5 weeks

  3. Recruitment rate

    To measure the acceptability of the proposed rehabilitation

    Measured: Pre-intervention

Secondary outcomes (8)

  1. 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).

    Measured: Pre-intervention and up to 5 weeks

  2. Action Research Arm Test

    It is a 19 item observational measure used to assess upper extremity performance on a scale of 0 - 57 (best).

    Measured: Pre-intervention and up to 5 weeks

  3. Modified Ashworth Scale

    This looks at elbow and wrist flexors on predefined scale. The scale ranges from 0 to 4 (worst).

    Measured: Pre-intervention and up to 5 weeks

  4. 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.

    Measured: Pre-intervention and up to 5 weeks

  5. 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).

    Measured: Baseline and up to 5 weeks

  6. 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)

    Measured: Pre-intervention and up to 5 weeks

  7. 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)

    Measured: within 10 minutes after experimental session

  8. 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.

    Measured: Pre-intervention and .up to 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start15 Jun 2022
  3. Primary completion30 Nov 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215522
Sponsor's protocol ID
USheffield1
Status last verified
Dec 2021
First submitted
13 Dec 2021
Last updated
15 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Mansour S, Giles J, Nair KPS, Marshall R, Ali A, Arvaneh M. A clinical trial evaluating feasibility and acceptability of a brain-computer interface for telerehabilitation in patients with stroke. J Neuroeng Rehabil. 2025 Apr 24;22(1):91. doi: 10.1186/s12984-025-01607-x.

    PubMed 40269846

Questions about this trial

What is this clinical trial studying?

A study testing The BCI-FES Intervention in people with Stroke, run by University of Sheffield at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES (time frame: within 10 minutes after experimental session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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