Trials / Recruiting
RecruitingNCT06610591
Efficacy of Surgery for Idiopathic Toe Walking
Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 8 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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 diagnosis to explain why. This is called as idiopathic toe walking and can cause problems with balance, pain and playing sports. For children with idiopathic toe walking who cannot touch their heels to the floor in standing, surgery is often done to lengthen their Achilles Tendon. This makes it easier to bend their foot towards their shin. They should then be able to walk. with their heels down in a more typical walking pattern. However, this improvement is not always long-term. Some children experience problems after surgery, including weak legs. 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 take part in two hospitals, Oxford University Hospitals and St George\'s Hospitals. 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. This means it is a smaller trial with 20 participants. The results will be used to decide if a larger trial is needed, and how a larger trial should be run. The children in the study will be 8-16 years old, with a tight Achilles Tendon, who have been selected for surgery. They will receive usual care. This means their surgery will be no different than if they were not included in the study. The children will be given questionnaires with a maximum of 22 questions before surgery, six months after surgery and one year after surgery. They will also do a single heel-rise test before surgery and one year after surgery. This will test if their calf muscle strength has changed after surgery. They will also complete a computerised walking analysis before surgery and one year after surgery. This will test if their walking pattern has changed after surgery. They will also complete a satisfaction questionnaire one year after surgery. This will ask about how satisfied they are with the surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Achilles Lengthening Surgery | The procedure is undertaken under general anaesthetic and involves horizontal hemi-section of the Achilles tendon via small 'stab' incisions at three levels to effect a lengthening of the tendon. The patient is then placed in a walking cast for four weeks thereafter. This surgery is usual care for most children with symptomatic ITW with plantarflexion contractures who have failed non-operative management. |
Timeline
- Start date
- 2024-09-09
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2024-09-24
- Last updated
- 2024-09-24
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT06610591. Inclusion in this directory is not an endorsement.