The effects of prolonged wear of textured shoe insoles on walking in people with Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Walking Impairment; Falls Risk; Neurological - Multiple sclerosis; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12615000421538
• Lead Sponsor: Dr Anna Hatton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-04
• Study Completion: 2018-03-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Men and women aged >18 years, with a clinical diagnosis of Multiple Sclerosis; Disease Steps grading 1-4; and ambulant over 100 metres with or without the use of an assistive device (cane/crutch).

Exclusion Criteria

Neurological conditions other than Multiple Sclerosis;
Peripheral neuropathy to a degree that would preclude the ability to perceive the textured insole;
Currently being prescribed over-the-counter or custom-made foot orthoses;
Cardiovascular or orthopaedic conditions including recent injury to the back or legs limiting ambulation;
Unstable psychiatric condition;
Cognitive impairment.

Participants who report a formal exacerbation of Multiple Sclerosis symptoms persisting >24hrs, four weeks prior to, or at any time during, the intervention period will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temporospatial Gait Parameters: <br>Base of Support, Stride Length, Stride Time Variability, Double-Limb Support Time, Gait Velocity during walking over even and uneven surfaces.<br>Measured using an electronic walkway (GAITRite) and motion capture system (Vicon).[Measured at: <br>Baseline Assessment 1 (Upon entry into study)<br>Baseline Assessment 2 (4 weeks after Baseline Assessment 1, prior to the commencement of insole use) <br>Assessment 3 (3-months after the commencement of insole use)]