FOREFOOT Study
Research type
Research Study
Full title
Evaluating the efficacy of surgical intervention for idiopathic toe walking: A prospective cohort pilot study
IRAS ID
324762
Contact name
Alpesh Kothari
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Background:
It is common for children who learn to walk to walk on their tiptoes to help with their balance. However, approximately 7% of children will continue to walk on their toes past the age of three, with no established diagnosis to explain why. This is defined as idiopathic toe walking (ITW) and can cause problems with balance, pain and participating in sports.
For children with ITW who cannot touch their heels to the floor in standing, surgery is often performed to lengthen their Achilles Tendon. This makes it easier to bend their foot towards their shin, and therefore easier to walk with their heels down in a more familiar gait pattern.
However, this improvement is not always long-term, and some children experience problems after surgery including weak legs. There is little research to help children’s surgeons identify which children will benefit from surgery.
Methods:
This research study will investigate children who are going to have Achilles Tendon lengthening surgery for ITW across two hospitals, to explore if their quality of life, endurance, strength, range of movement or walking pattern improves after they have had the surgery. As this is a pilot study, there will be 20 participants and the results will be used to decide if a larger trial is needed and improve the design of a larger trial.
The children included in this study will be 8-16 years old at recruitment, with a tight Achilles Tendon, who have been selected for surgery. They will receive the usual care, meaning their surgery will be no different than if they were not included in the study.
The children will be given a questionnaire consisting of a maximum of 22 questions (which are suitable for children) about their walking, perform a single heel-rise test, and undergo gait analysis (a common method of analysing children’s walking in a gait laboratory) before surgery and one-year after surgery to test for any changes. They will also complete the questionnaires at 6-months after surgery. The children and parents will be asked to complete an additional short survey together one-year after surgery only on their satisfaction with the surgery.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0051
Date of REC Opinion
18 Mar 2024
REC opinion
Favourable Opinion