Efficacy of Surgery for Idiopathic Toe Walking
ConditionIdiopathic Toe-walking
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-16
SponsorUniversity of Oxford
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Achilles Lengthening Surgery
Procedure/SurgeryThe 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Achilles Lengthening Surgery1 intervention
Trial outcomes
Primary outcomes
1
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Quality of life tool
Time frame
Pre-surgery / six months post-surgery / one year post-surgerySecondary outcomes
1
EuroQol 5 Dimensions Youth (EQ-5D-Y)
Health related quality of life
Time frame
Pre-surgery / six months post-surgery / one year post-surgery2
Single heel rise test
Calf endurance test
Time frame
Pre-surgery / one year post-surgery3
Ankle range of motion
Measured with a long arm goniometer
Time frame
Pre-surgery / one year post-surgery4
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?
Time frame
Pre-surgery / six months post-surgery / one year post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
British Society for Children's Orthopaedic Surgery
Collaborator
Source ClinicalTrials.gov