Plain English Summary
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
Trial website
Contact information
Type
Public
Primary contact
Dr Bethel Osuagwu
ORCID ID
http://orcid.org/0000-0002-1238-7770
Contact details
National Spinal Injuries Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
+44 (0)1296315963
bethel.osuagwu@smsr.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Active FES - v1
Study information
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
Acronym
Active FES
Study hypothesis
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
Yorkshire & The Humber - Leeds East Research Ethics Committee, 06 /12/2017, REC ref: 17/YH/0416
Study design
Single-centre feasibility study of an interventional device
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
04/01/2017
Overall trial end date
25/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Known neurological condition, comorbidity (e.g., brain injury)
2. A person unable to understand verbal or written information in English
Recruitment start date
08/01/2018
Recruitment end date
25/01/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Buckinghamshire Healthcare NHS Trust
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
Organisation
Stoke Mandeville Hospital NHS Trust
Sponsor details
Research Office
Buckinghamshire Healthcare NHS Trust
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
+44 (0)1296316259
denise.watson@buckshealthcare.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Buckinghamshire NHS Trust Charitable Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stoke Mandeville Spinal Research (SMSR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
25/01/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list