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Efficacy of Surgery for Idiopathic Toe Walking

Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06610591
Acronym
FOREFOOT
Enrollment
20
Registered
2024-09-24
Start date
2024-09-09
Completion date
2026-09-01
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Toe-walking

Keywords

Children, Child, Paediatric, Pediatric, Idiopathic Toe-Walking, Surgery, Orthopaedic, Orthopedic, Pilot, FOREFOOT, Achilles Tendon

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.

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.

Interventions

PROCEDUREAchilles 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.

Sponsors

British Society for Children's Orthopaedic Surgery
CollaboratorUNKNOWN
University of Oxford
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)Pre-surgery / six months post-surgery / one year post-surgeryQuality of life tool

Secondary

MeasureTime frameDescription
Single heel rise testPre-surgery / one year post-surgeryCalf endurance test
Ankle range of motionPre-surgery / one year post-surgeryMeasured with a long arm goniometer
EuroQol 5 Dimensions Youth (EQ-5D-Y)Pre-surgery / six months post-surgery / one year post-surgeryHealth related quality of life
Patient Reported Experience Measure (PREM)One year post-surgerySatisfaction with the surgical outcome
Three Dimensional Gait Analysis (3DGA)Pre-surgery / one year post-surgeryThe comparisons of interest from the 3DGA will be the change from baseline to 1 year, and comparison between participants and age/gender matched control dataset at both time points in: Kinetics/Kinematics: * Mean pelvic tilt * Peak dorsiflexion angle during stance * Peak dorsiflexion angle during swing * Hindfoot inversion/eversion during stance * Peak knee flexion during stance * Peak internal plantarflexion moment * Peak internal knee flexion moment * Peak ankle power generation * Gait profile score Temporal parameters: * Normalised speed (metres per second, normalised for leg length/height) * Cadence (steps per minute) * Non dimensional stride length (metres, normalised to leg length)
Single questionPre-surgery / six months post-surgery / one year post-surgeryThinking of your child's walking over the past week, approximately how much of the time does your child walk on their tiptoes?

Countries

United Kingdom

Contacts

Primary ContactEileen M Morrow, BSc. MSc.
Eileen.Morrow@ouh.nhs.uk+441865 227 607

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026