Do customised fit shoes increase physical activity in children with Down syndrome?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: The intervention group will receive two pairs of standard commerically available shoes (from Clarks Australia); one pair for school and one pair for ordinary wear. The shoes will be custom fitted during a single one‐on‐one appointment (approximate duration of 1 hour) with a podiatrist trained in fitting shoes. The school shoes will be Clarks Laura (females) or Lochie (males) model shoes. Participants that have feet that are too large for the Laura/Lochie styles or prefer lace‐up shoes will be provided with Daytona model shoes. Ordinary wear shoes will be Clarks Ventura model (males and females) shoes. Participants that prefer lace‐up shoes will be provided with Vancouver model shoes. The duration of the intervention will be 12 weeks. Participants will be expected to use the school shoes when they go to school and use the ordinary wear shoes at other times (i.e. when they are not at school but are wearing shoes). Adherence will be monitored by specially designed questionnaire that the parents will complete at 6 and 12 weeks. CONDITION: Foot health in Down syndrome Physical activity in Down syndrome PRIMARY OUTCOME: Physical activity (using an Actigraph activity monitor collected over 7 days) INCLUSION CRITERIA: Children and adolescents with Down syndrome will be eligible for inclusion in the trial if they are aged between 5 and 17 years and have the ability to follow simple verbal instructions in English. SECONDARY OUTCOME: Acceptability of the custom fit shoes (experimental group) via semi‐structured interview of the participants and carers/parents Adherence to the intervention (experimental group only) will be determined by survey of parents/next of kin. Parents of the participants will provide information regarding the number of hours per day and number of days they have worn their shoes during the previous 6 weeks. The survey has been specifically designed for this study. Adverse events (such as new pains in the body, rolled ankles, blisters, swelling) will be assessed via survey completed by the parents/next of kin. The survey has been specifically designed for this study. Base of support (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Cadence (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Double leg support time (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Foot‐specific disability (emotional domain) using the Oxford Ankle Foot Questionnaire for Children ‐ parent reported version Foot‐specific disability (physical domain) using the physical domain of the Oxford Ankle Foot Questionnaire for Children) ‐ parent reported version Foot‐specific disability (school and play domain) using the Oxford Ankle Foot Questionnaire for Children ‐ parent reported version Single leg support time (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Stance time (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Step length (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Step time (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Step width (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Stride length (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Stride width (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Toe in/out angle (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes) Use of co‐interventions (such as new shoes that have not been prescribed in this study, visits to health care providers for treatment of any foot conditions) will be assessed via a survey. The survey has been specifically designed for this study. Walking velocity (using the GAITRite system) wearing the pre‐study entry shoes and custom fitted shoes (both ordinary wear and school shoes)
Epistemonikos ID: 72cd9a2d19f41490ab17f60ef91e0f62d592c822
First added on: Aug 24, 2024