Condition category
Injury, Occupational Diseases, Poisoning
Date applied
08/01/2018
Date assigned
26/01/2018
Last edited
23/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Publication citations

Additional files

Editorial Notes