The long-term effects of textured shoe insoles on balance, walking ability and function in people with multiple sclerosis

Not Applicable

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN85766784
• Lead Sponsor: Teesside University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-07
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Be aged between 18 and 65
2. Have a clinical diagnosis of MS
3. Be able to walk 100m independently, with or without a unilateral walking aid

Exclusion Criteria

1. Current acute exacerbation and/or relapse of symptoms within the last three months
2. Diagnoses of any other condition affecting the central nervous system, for example Parkinson?s Disease
3. Any musculoskeletal injury or condition for which a health professional has advised the person to refrain from undertaking moderate physical activity
4. Inability to give informed consent
5. Inability to read or speak English
6. Inability to feel the textured insoles (foot sole sensitivity tested using Semmes-Weinstein monofilaments to exclude people with peripheral neuropathy)
7. Current use of textured insoles or shoes with textured insoles

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Spatio­-temporal parameters of gait, recorded by an electronic GAITRite mat<br>2. Standing balance during quiet bipedal stance, recorded by a Kistler (TM) force plate<br>3. Functional mobility, measured by the timed-­up­-and­-go test<br>4. Qualitative information regarding acceptability and comfort of the insole interventions, gathered in semi-structured interviews and focus groups at the end of the study

Secondary Outcome Measures

Name	Time	Method
1. Self-reported health, measured using the EQ-5D-5L<br>2. Self-reported fatigue, measured using the modified fatigue impact scale<br>3. Self-reported pain level, measured using the Medical Outcomes Study (MOS) pain effects scale<br>4. Self-reported cognitive deficits, measured using the perceived deficits questionnaire<br>5. Self-reported fear of falling, measured using the falls efficacy scale International<br>6. Self-reported walking ability, measured using the MS Walking Scale (MSWS­12)