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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2014
INTERVENTION: 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.) 3. Control ?‐ no insole CONDITION: Multiple sclerosis ; Nervous System Diseases ; Multiple sclerosis PRIMARY OUTCOME: 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 OUTCOME: 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) 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
Epistemonikos ID: 1fb05dbccf5eefd89234fbeb739c43d7d08d9a9e
First added on: Aug 22, 2024