Condition category
Nervous System Diseases
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
30/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Dixon

ORCID ID

Contact details

Health and Social Care Institute
Borough Road
Middlesbrough
TS1 3BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7926

Study information

Scientific title

Acronym

Textured Insoles & Balance in MS Version 3

Study hypothesis

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

MREC approved on the 3rd June 2009 (ref: 09/H0903/35)

Study design

Single centre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Balance

Secondary outcome measures

1. Muscle activation
2. The effects on balance of wearing textured insoles for two weeks

Overall trial start date

01/07/2009

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 50; UK sample size: 50

Participant 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

Recruitment start date

01/07/2009

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health and Social Care Institute
Middlesbrough
TS1 3BA
United Kingdom

Sponsor information

Organisation

Multiple Sclerosis Society (UK)

Sponsor details

Research and Development
372 Edgware Road
London
NW2 6ND
United Kingdom

Sponsor type

Charity

Website

http://www.mssociety.org.uk/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society (UK)

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24070573

Publication citations

  1. Results

    Dixon J, Hatton AL, Robinson J, Gamesby-Iyayi H, Hodgson D, Rome K, Warnett R, Martin DJ, Effect of textured insoles on balance and gait in people with multiple sclerosis: an exploratory trial., Physiotherapy, 2014, 100, 2, 142-149, doi: 10.1016/j.physio.2013.06.003.

Additional files

Editorial Notes