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

The long-term effects of textured shoe insoles on balance, walking ability and function in people with multiple sclerosis: an exploratory randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85766784

Enrollment

Registered

2014-04-07

Start date

2014-04-01

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

Patients are randomised to three arms: 1. Intervention -? textured insoles (Evalite Pyramid EVA 3mm thickness, Algeos Ltd.) 2. Control -? smooth insole (medium density EVA, 3mm thickness, Algeos Ltd.)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Spatio-temporal parameters of gait, recorded by an electronic GAITRite mat 2. Standing balance during quiet bipedal stance, recorded by a Kistler (TM) force plate 3. Functional mobility, measured by the timed-up-and-go test 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

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026