Active functional electrical stimulation
| ISRCTN | ISRCTN28779644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28779644 |
| Secondary identifying numbers | Active FES - v1 |
- Submission date
- 08/01/2018
- Registration date
- 26/01/2018
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Hand function is essential for daily living activities. People with spinal cord injury (SCI) can suffer from impaired hand functions. Conventional hand therapy is usually offered at the sub-acute stage of SCI but patients still experience significantly impaired hand function which affects their daily living activities and reduces their quality of life. A system has been developed that uses the electrical signal of the muscles to control functional electrical stimulation of the same muscles. The aim of this study is to determine the best parameters and confirm that people with SCI can adequately use the system both as a rehabilitative and assistive device.
Who can participate?
Patients aged 18–76 with high level SCI that affects their hand function
What does the study involve?
Each participant receives functional electrical stimulation to open and close the hand, controlled by the electrical signals of their muscles. There is a total of three sessions with each session lasting for a maximum of 2 hours.
What are the possible benefits and risks of participating?
There are no known direct benefits to participants but the result will help in further research in the area. There is no known risk as devices are certified.
Where is the study run from?
National Spinal Injuries Centre (NSIC), Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
Buckinghamshire Healthcare NHS Trust (UK)
Who is funding the study?
January 2017 to January 2019
Who is the main contact?
Dr Bethel Osuagwu
bethel.osuagwu@smsr.org.uk
Contact information
Public
National Spinal Injuries Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
 ORCID ID |
0000-0002-1238-7770 |
|---|---|
| Phone | +44 (0)1296315963 |
| bethel.osuagwu@smsr.org.uk |
Study information
| Study design | Single-centre feasibility study of an interventional device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Feasibility of two-channel proportional Electromyogram Controlled Functional Electrical Stimulation (EMG-FES) for augmentation of finger and wrist flexion and extension for application in active neurorehabilitation in spinal cord injury |
| Study acronym | Active FES |
| Study objectives | There is evidence that active participation is important in movement rehabilitation. One of the methods of involving active participation during rehabilitation is to control rehabilitation system with voluntary effort. For this purpose, Electromyogram (EMG) has been investigated to trigger the onset or proportionally control the intensity of functional electrical stimulation (FES). The proportional control method is very attractive because it gives a more natural control but it is more difficult to implement because of the issues associated with recording EMG simultaneously with the application of FES. Recent developments have demonstrated potentials of single channel proportional EMG controlled FES as an orthotic and rehabilitation system that can argument either tenodesis, hand flexion or extension. Here the aim is to further research and test the feasibility of a two-channel proportional EMG controlled FES system that can augment both hand and wrist flexion and extension in addition to tenodesis grasp and release |
| Ethics approval(s) | Yorkshire & The Humber - Leeds East Research Ethics Committee, 06 /12/2017, REC ref: 17/YH/0416 |
| Health condition(s) or problem(s) studied | Spinal cord Injury |
| Intervention | Each participant will receive functional electrical stimulation (FES) to open and close the hand. The FES will be controlled by the person's residual electromyogram. There will be a total of three sessions with each session lasting for a maximum of 2 hours. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The following tests will be measured only once for each condition in the study: 1. Hand function, measured using Toronto rehabilitation institute hand function test (TRI-HFT) 2. Hand function, measured using trapezoidal shape tracing |
| Secondary outcome measures | The following tests will be measured only once for each condition in the study: 1. Physical well-being, assessed using the spinal cord independence measure (SCIM) 2. Spasticity muscle hypertonia levels, assessed using the Modified Ashworth Scale (MAS) test 3. Device usability and usefulness, assessed using a series of questionnaires including the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 4. Functional impairment, assessed using the International Neurological Standards for Spinal Cord Injury (ASIA impairment scale) |
| Overall study start date | 04/01/2017 |
| Completion date | 30/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. 18–76 years old 2. Sub-acute and chronic incomplete tetraplegia (neurological level C2 – T1), AIS grade B to D 3. Presence of residual EMG activity during hand flexion and extension |
| Key exclusion criteria | 1. Known neurological condition, comorbidity (e.g., brain injury) 2. A person unable to understand verbal or written information in English |
| Date of first enrolment | 08/01/2018 |
| Date of final enrolment | 30/08/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
Hospital/treatment centre
Research Office
Buckinghamshire Healthcare NHS Trust
Mandeville Road
Aylesbury
HP21 8AL
England
United Kingdom
| Phone | +44 (0)1296316259 |
|---|---|
| denise.watson@buckshealthcare.nhs.uk | |
"ROR" |
https://ror.org/0524j1g61 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | 30/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Additional documents (such as study protocol, statistical analysis plan, other) are/will be available on request from Dr Bethel Osuagwu (bethel.osuagwu@gmail.com). Planned publication of the study results in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/12/2020 | 27/02/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/02/2023: Publication reference added.
05/09/2019: The final enrolment number has been added.
23/04/2019: The following changes were made to the trial record:
1. The overall end date was changed from 25/01/2019 to 30/08/2019.
2. The intention to publish date was changed from 25/01/2018 to 30/08/2020.
3. The recruitment end date was changed from 25/01/2019 to 30/08/2019.
