None listed
Conditions
Brief summary
The aim of this study is: To conduct a pilot randomised controlled trial to evaluate if wearing customised fit shoes increases physical activity among children and adolescents with Down syndrome. The research questions are: In children with Down syndrome: * Does improving shoe fit increase physical activity? * Does improving shoe fit improve foot specific disability, and walking patterns? * Are customised fit shoes acceptable? The study methods are: We will conduct a pilot randomised trial to compare customised fit shoes (intervention) to a waitlist (control) group for children with Down syndrome. Thirty participants with Down syndrome aged 5 to 17 years will be recruited, and randomly allocated to one of two groups. The intervention group (15 children) will receive two pairs of customised fit shoes (from Clarks Australia): one pair for school and one pair for ordinary wear. The control group (15 children) will continue wearing their existing shoes for 12 weeks (and will then receive two pairs of customised fit shoes). Participants will be assessed at the start of the study (baseline/week 0), then at 6, and 12 weeks. Four outcomes will be measured: (1) physical activity (using an activity monitor collected over 7 days) (main outcome), (2) computerised gait analysis, (3) foot-specific disability using a questionnaire called the Oxford Ankle Foot Questionnaire for Children, and (4) acceptability of the intervention (using an interview approach).
Interventions
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 pr
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.
Sponsors
Shannon Munteanu
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Healthy volunteers
Yes
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.
Exclusion criteria
Participants will be excluded from the trial if there is an acute or subacute medical reason why their physical activity levels might be affected on an on-going basis (e.g. previous lower limb surgery, unable to walk without a supportive device such as a walker or brace), or a concomitant medical condition or injury that could affect their physical function (e.g. neurological or inflammatory disorder). Participants will also be excluded from the trial after the initial assessment if they cannot adhere to wearing a monitor to measure the amount of physical activity they do for at least 10 hours on at least 4 days including at least one weekend day.
Outcome results
None listed