Soft extra muscle glove study for spinal cord injury
| ISRCTN | ISRCTN98677526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98677526 |
| Secondary identifying numbers | 31283 |
- Submission date
- 31/05/2017
- Registration date
- 01/06/2017
- Last edited
- 10/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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
Contact information
Scientific
Sensorimotor Function Group
Hospital Nacional de Parapléjicos
Finca "La Peraleda"
Toledo
45071
Spain
| Phone | +34 692163048 |
|---|---|
| juliantaylorgreen2@gmail.com |
Study information
| Study design | Both; Design type: Device, Cohort study; Longitudinal interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN98677526_PIS_08Jun16_V3.0.docx |
| 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 |
| 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(s) | London - City & East Research Ethics Committee, 22/05/2016, ref: 16/LO/1007 |
| 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 |
| Primary outcome measure | 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 study start date | 25/01/2016 |
| Overall study end date | 30/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 15; UK Sample Size: 15 |
| Total final enrolment | 15 |
| 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 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
- England
- United Kingdom
Study participating centre
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
Hospital/treatment centre
Amersham Hospital
Whielden Street
Amersham
HP7 0JD
England
United Kingdom
| Phone | +44 1296 316259 |
|---|---|
| denise.watson@buckshealthcare.nhs.uk | |
"ROR" |
https://ror.org/037f2xv36 |
Funders
Funder type
Industry
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 21/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication is planned in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Bethel.Osuagwu@smsr.org.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3.0 | 08/06/2016 | 01/06/2017 | No | Yes |
| Results article | results | 05/03/2020 | 10/03/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN98677526_PIS_08Jun16_V3.0.docx
- Uploaded 01/06/2017
Editorial Notes
10/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
28/06/2019: Dr Julian Taylor's contact details have been updated.
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
