Condition category
Nervous System Diseases
Date applied
31/05/2017
Date assigned
01/06/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The spinal cord is a bundle of nerve fibres which is encased in a bony column (known as the spine). It is the most important link between the brain and the other nerves in the body (peripheral nervous system). Damage to the spinal cord (spinal cord injury, SCI) can lead to serious consequences. SCI can range from mild to severe, and can cause a partial or total loss of movement, often leaving people with life-long disability. People with spinal cord injury (SCI) can suffer from significantly impaired hand function. Conventional hand therapy is usually offered in the relatively early stages of SCI but individuals with long-term SCI still experience significant problems which affect activities of daily living (routine activities that people tend do every day without needing assistance) and quality of life. This study is looking at a unique device called the soft extra muscle (SEM) Glove. The SEM glove detects the voluntary effort to grasp an object and proportionally ‘strengthens’ the hand to complete the grasping function. The aim of this study is to test the benefits of the SEM Glove as an assistive device and a rehabilitation device.

Who can participate?
Adults with tetraplegia (partial or total loss of use of all four limbs and torso) who have had SCI for at least one year.

What does the study involve?
All participants are provided with a SEM Glove unit to use for activities of daily living for a total of 12 weeks in their own homes. Participants visit the National Spinal Injuries Centre at the start of the study and after six, 12 and 18 weeks in order to complete assessments of function, pain and independence, as well as questionnaires about their quality of life and the usability of the glove.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their performance of activities of daily living. Long-term use of the glove may also have a long-term rehabilitative effect. There are no notable risks involved with participating.

Where is the study run from?
National Spinal Injuries Centre (UK)

When is study starting and how long is it expected to run for?
January 2016 to April 2018

Who is funding the study?
1. Anatomical Concepts (U.K.) Limited (UK)
2. Bioservo Technologies AB (UK)
3. Stoke Mandeville Spinal Research (UK)

Who is the main contact?
Dr Julian Taylor
julian.taylor@smsr.org.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian Taylor

ORCID ID

Contact details

Stoke Mandeville Spinal Research
National Spinal Injuries Centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
+44 1296 316 783
julian.taylor@smsr.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31283

Study information

Scientific title

Clinical trial of the Soft Extra Muscle Glove to assess orthotic and long-term functional gain following chronic incomplete tetraplegia: A longitudinal mixed methods study

Acronym

Study hypothesis

The aim of this study is to test the benefit to chronic spinal cord injury (SCI) individuals wearing a unique assistive device called the soft extra muscle (SEM) Glove.

Ethics approval

London - City & East Research Ethics Committee, 22/05/2016, ref: 16/LO/1007

Study design

Both; Design type: Device, Cohort study; Longitudinal interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Neurological disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the abdomen, lower back, lumbar spine and pelvis

Intervention

Participants will be provided with a SEM Glove unit to use for activities of daily living for a total of 12 weeks.

Using questionnaires, neurophysiological and functional measures, the participants will be assessed before, at 6, 12 weeks and followed after 18 weeks of using the glove in their own homes. The functional outcome measures will be performed with and without the participants wearing the glove during the baseline recording and at 12 weeks

Intervention type

Other

Phase

Drug names

Primary outcome measures

Hand function is measured using dynamometry and Toronto Rehabilitation Institute hand function test at baseline, 6 week,12 weeks and 18 weeks.

Secondary outcome measures

1. Pain is measured using the Visual analogue scale (VAS) at baseline, 6 week,12 weeks and 18 weeks.
2. Sensation is measured using The Rivermead Assessment of Somatosensory Performance (RASP) at baseline and 12 weeks
3. Spasticity is measured using Modified Ashworth Scale (MAS) test:- at baseline, 6 week,12 weeks and 18 weeks.
4. Spinal cord injury level is measured using the American Spinal Injury Association Impairment Scale (AIS) at baseline and 12 weeks
5. Performance and satisfaction rating of selected activities is measured using Canadian Occupational Performance Measure (COPM) at baseline and 12 weeks
6. The level of independence is assessed using the self-care sub-scale of spinal cord independence measure (SCIM) at baseline and 12 weeks
7. Quality of life is measured using the short form 36 at baseline and 12 weeks
8. The usability of the glove is assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) at 12 weeks

Overall trial start date

25/01/2016

Overall trial end date

30/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18-65 years
2. Incomplete tetraplegia (spinal level C2 – C8) , AIS grade C or D
3. At least 12 months post SCI (chronic)
4. Reduced muscle power resulting in reduced grip/pinch strength

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 15; UK Sample Size: 15

Participant exclusion criteria

1. Known neurological condition, comorbidity (eg. brain injury).
2. A person unable to understand verbal or written information in English.

Recruitment start date

01/11/2016

Recruitment end date

30/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Spinal Injuries Centre
Stoke Mandeville Spinal Research Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

Sponsor information

Organisation

Buckinghamshire Healthcare NHS Trust

Sponsor details

Amersham Hospital
Whielden Street
Amersham
HP7 0JD
United Kingdom
+44 1296 316259
denise.watson@buckshealthcare.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Anatomical Concepts (U.K.) Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bioservo Technologies AB

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stoke Mandeville Spinal Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication is planned in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Bethel.Osuagwu@smsr.org.uk.

Intention to publish date

21/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.