NCT06610591 Efficacy of Surgery for Idiopathic Toe Walking
| NCT ID | NCT06610591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Idiopathic Toe-walking |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-09 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-09-09 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
BACKGROUND: For children who walk on their tip toes, surgery is often done to lengthen their Achilles Tendon. However, there is little research to help children's surgeons choose which children with idiopathic toe walking should have surgery. METHODS: This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking. It will explore if the children\'s quality of life, endurance, strength, range of movement or walking pattern improves after they have had surgery. This study is a pilot study with 20 participants. This means the results will be used to decide if a larger trial is needed.
Eligibility Criteria
Inclusion Criteria: * Children aged 8-16 at recruitment. * Idiopathic toe walkers based on clinicians' assessment. * Plantarflexion contracture with knee extended of 0 degrees or less of dorsiflexion. * Listed for surgical lengthening of the plantarflexors. Exclusion Criteria: * Unable to give informed assent or consent. Previous surgery to the lower limb. * Unable to effectively participate in gait analysis (e.g. unable to walk 10-metres unaided, unable to walk independently, allergy to adhesive for skin markers, hyperhidrosis). * Underlying diagnoses which may cause toe walking (e.g. muscular dystrophy, split cord malformation, cerebral palsy). * Listed for additional procedures in the surgery for the lengthening of the plantarflexors. * Awaiting further investigations or neurology assessment for toe walking pattern.
Contact & Investigator
Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT06610591 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Idiopathic Toe-walking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610591 currently recruiting?
Yes, NCT06610591 is actively recruiting participants. Contact the research team at Eileen.Morrow@ouh.nhs.uk for enrollment information.
Where is the NCT06610591 trial being conducted?
This trial is being conducted at Tooting, United Kingdom, Oxford, United Kingdom.
Who is sponsoring the NCT06610591 clinical trial?
NCT06610591 is sponsored by University of Oxford. The principal investigator is Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil at University of Oxford. The trial plans to enroll 20 participants.