Clinical trial NCT06610591: Efficacy of Surgery for Idiopathic Toe Walking
Official title: Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Toe-walking
Keywords: Children
Child
Paediatric
Pediatric
Idiopathic Toe-Walking
Surgery
Orthopaedic
Orthopedic
Pilot
FOREFOOT
Achilles Tendon
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: British Society for Children&#39;s Orthopaedic Surgery
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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\&#39;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\&#39;s Hospitals. It will explore if the children\&#39;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.

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.

Primary outcomes:
measure: Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
timeFrame: Pre-surgery / six months post-surgery / one year post-surgery
Secondary outcomes:
measure: EuroQol 5 Dimensions Youth (EQ-5D-Y)
timeFrame: Pre-surgery / six months post-surgery / one year post-surgery
measure: Single heel rise test
timeFrame: Pre-surgery / one year post-surgery
measure: Ankle range of motion
timeFrame: Pre-surgery / one year post-surgery
measure: Single question
timeFrame: Pre-surgery / six months post-surgery / one year post-surgery
measure: Patient Reported Experience Measure (PREM)
timeFrame: One year post-surgery
measure: Three Dimensional Gait Analysis (3DGA)
timeFrame: Pre-surgery / one year post-surgery
Other outcomes:
Locations:
city: Tooting
country: United Kingdom
facility: St George&#39;s University Hospitals NHS Foundation Trust
state: London
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: St George&#39;s University Hospitals NHS Foundation Trust
name: Yael Gelfer, BSc, MD, PhD, FRCS
role: STUDY_DIRECTOR
affiliation: University of Oxford
name: Julie Stebbins, DPhil SRCS CSci
role: STUDY_DIRECTOR
References: