Efficacy of Surgery for Idiopathic Toe Walking (FOREFOOT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Toe-walking
• Intervention / Treatment: Procedure: Achilles Lengthening Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Eileen M Morrow, BSc. MSc.; Phone Number: +441865 227 607; Email: Eileen.Morrow@ouh.nhs.uk

Study Locations

• United Kingdom
  • London
    • Tooting, London, United Kingdom, SW17 0QT
      • Recruiting
      • St George's University Hospitals NHS Foundation Trust
      • Contact: Yael Gelfer, BSc, MD, PhD, FRCS; Phone Number: +4420 8725 6749; Email: Adam.phillipsz@stgeorges.nhs.uk
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • Oxford University Hospitals NHS Foundation Trust
      • Contact: Eileen M Morrow, BSc. MSc.; Phone Number: +44 1865 227 607; Email: Eileen.Morrow@ouh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population relevant to this study will be children aged 8-16 years old (inclusive) with idiopathic toe walking, estimated to affect 5% of healthy children.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Achilles Lengthening Surgery; Participants will receive Achilles lengthening surgery, as usual care.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)	Quality of life tool	Pre-surgery / six months post-surgery / one year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol 5 Dimensions Youth (EQ-5D-Y)	Health related quality of life	Pre-surgery / six months post-surgery / one year post-surgery
Single heel rise test	Calf endurance test	Pre-surgery / one year post-surgery
Ankle range of motion	Measured with a long arm goniometer	Pre-surgery / one year post-surgery
Single question	Thinking of your child's walking over the past week, approximately how much of the time does your child walk on their tiptoes?	Pre-surgery / six months post-surgery / one year post-surgery
Patient Reported Experience Measure (PREM)	Satisfaction with the surgical outcome	One year post-surgery
Three Dimensional Gait Analysis (3DGA)	The 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)	Pre-surgery / one year post-surgery

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: British Society for Children's Orthopaedic Surgery
• Investigators: Principal Investigator: Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil, University of Oxford; Study Director: Yael Gelfer, BSc, MD, PhD, FRCS, St George's University Hospitals NHS Foundation Trust; Study Director: Julie Stebbins, DPhil SRCS CSci, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Child; Surgery; Children; Pediatric; Paediatric; Pilot; Orthopaedic; Achilles Tendon; Orthopedic; Idiopathic Toe-Walking; FOREFOOT
• Other Study ID Numbers: PID:17261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This was not included in the participant information sheets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No