Wearing textured insoles in shoes to help selfmanagement for people with MS: an exploratory study of the effects on balance
| ISRCTN | ISRCTN02778739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02778739 |
| Secondary identifying numbers | 7926 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 30/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Dixon
Scientific
Scientific
Health and Social Care Institute
Borough Road
Middlesbrough
TS1 3BA
United Kingdom
Study information
| Study design | Single centre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | Textured Insoles & Balance in MS Version 3 |
| Study objectives | To explore if wearing textured insoles in footwear can affect balance for people with multiple sclerosis (MS). The overall context of the study is about the use of footwear as an aid to improving balance in people with multiple sclerosis (MS). The results from this study on the effects of wearing insoles will serve to inform further work into the use of textured insoles to improve balance in people with MS. |
| Ethics approval(s) | MREC approved on the 3rd June 2009 (ref: 09/H0903/35) |
| Health condition(s) or problem(s) studied | Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders |
| Intervention | The project will see if wearing insoles with a rough texture in shoes can help people affected by multiple sclerosis. We will investigate two different textured insoles (using a smooth insole as a control) to see if either or both can change people's ability to maintain their balance when standing and when walking. We will study what happens the first time they wear the textured insoles and also after two weeks of wearing them. |
| Intervention type | Other |
| Primary outcome measure | Balance |
| Secondary outcome measures | 1. Muscle activation 2. The effects on balance of wearing textured insoles for two weeks |
| Overall study start date | 01/07/2009 |
| Completion date | 31/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 50; UK sample size: 50 |
| Key inclusion criteria | 1. Men and women aged between 18 - 65 years 2. Clinical diagnosis of MS 3. Can walk about 100 m with or without resting with the use of one stick or crutch |
| Key exclusion criteria | Any potential participant will be excluded from the study for any of the following reasons: 1. Diagnosis of other central nervous system condition 2. Musculoskeletal injury within last 6 weeks 3. Relapse of symptoms in the last three months 4. Reduced sensation in either or both feet of a degree that would preclude them perceiving the textures 5. Known allergy to or subsequent allergic reaction to hypoallergenic tape 6. Inability to understand instructions 7. Unable to walk 10 metres (11 yards) without resting, either unassisted or with one stick or crutch 8. Previous use of these or similar textured insoles |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 31/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Health and Social Care Institute
Middlesbrough
TS1 3BA
United Kingdom
TS1 3BA
United Kingdom
Sponsor information
Multiple Sclerosis Society (UK)
Charity
Charity
Research and Development
372 Edgware Road
London
NW2 6ND
United Kingdom
| Website | http://www.mssociety.org.uk/ |
|---|---|
"ROR" |
https://ror.org/043fwdk81 |
Funders
Funder type
Charity
Multiple Sclerosis Society (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2014 | Yes | No |
