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NCT Number: NCT06610591

Efficacy of Surgery for Idiopathic Toe Walking

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.

Recruiting

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St George's University Hospitals NHS Foundation Trust, Tooting, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Achilles Lengthening Surgery

Procedure

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.

Primary outcomes

  1. Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)

    Time frame: Pre-surgery / six months post-surgery / one year post-surgery

    Quality of life tool

Secondary outcomes

  1. EuroQol 5 Dimensions Youth (EQ-5D-Y)

    Time frame: Pre-surgery / six months post-surgery / one year post-surgery

    Health related quality of life

  2. Single heel rise test

    Time frame: Pre-surgery / one year post-surgery

    Calf endurance test

  3. Ankle range of motion

    Time frame: Pre-surgery / one year post-surgery

    Measured with a long arm goniometer

  4. Single question

    Time frame: Pre-surgery / six months post-surgery / one year post-surgery

    Thinking of your child's walking over the past week, approximately how much of the time does your child walk on their tiptoes?

  5. Patient Reported Experience Measure (PREM)

    Time frame: One year post-surgery

    Satisfaction with the surgical outcome

  6. Three Dimensional Gait Analysis (3DGA)

    Time frame: Pre-surgery / one year post-surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eileen M Morrow, BSc. MSc.

CONTACT

[email protected]

+441865 227 607

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • British Society for Children's Orthopaedic Surgery

Registry information

Official study title

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

Acronym: FOREFOOT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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