Idiopathic Toe-walkingFOREFOOTNCT06610591
Efficacy of Surgery for Idiopathic Toe Walking
An observational study of Idiopathic Toe-walking, run by University of Oxford at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Idiopathic Toe-walking
- What is being tested?
- Achilles Lengthening Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Sep 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Eileen M Morrow, BSc. MSc., +44 1865 227 607, Eileen.Morrow@ouh.nhs.uk
- Recruiting
St George's University Hospitals NHS Foundation Trust
Tooting, London, SW17 0QT
Yael Gelfer, BSc, MD, PhD, FRCS, +4420 8725 6749, Adam.phillipsz@stgeorges.nhs.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Toe-walking
- Being tested
- Achilles Lengthening Surgery
- Keywords
- Children, Child, Paediatric, Pediatric, Idiopathic Toe-Walking, Surgery, Orthopaedic, Orthopedic, Pilot, FOREFOOT, Achilles Tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles Lengthening SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Achilles Lengthening Surgery | Participants will receive Achilles lengthening surgery, as usual care. Receives: Procedure: Achilles Lengthening Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Quality of life tool
Measured: Pre-surgery / six months post-surgery / one year post-surgery
Secondary outcomes (6)
EuroQol 5 Dimensions Youth (EQ-5D-Y)
Health related quality of life
Measured: Pre-surgery / six months post-surgery / one year post-surgery
Single heel rise test
Calf endurance test
Measured: Pre-surgery / one year post-surgery
Ankle range of motion
Measured with a long arm goniometer
Measured: 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?
Measured: Pre-surgery / six months post-surgery / one year post-surgery
Patient Reported Experience Measure (PREM)
Satisfaction with the surgical outcome
Measured: 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)
Measured: Pre-surgery / one year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start9 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Toe-walkingStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- British Society for Children's Orthopaedic Surgery
- Responsible party
- Sponsor
- Investigators
- Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil, Principal investigator, University of OxfordYael Gelfer, BSc, MD, PhD, FRCS, Study director, St George's University Hospitals NHS Foundation TrustJulie Stebbins, DPhil SRCS CSci, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610591
- Sponsor's protocol ID
- PID:17261
- Acronym
- FOREFOOT
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not included in the participant information sheets.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking: A Prospective Cohort Pilot Study
- ClinicalTrials.gov ID
- NCT06610591
- Acronym / sponsor ID
- FOREFOOT / PID:17261
- Conditions
- Idiopathic Toe-walking
- Keywords
- Children, Child, Paediatric, Pediatric, Idiopathic Toe-Walking, Surgery, Orthopaedic, Orthopedic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- British Society for Children's Orthopaedic Surgery
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Achilles Lengthening Surgery | – | Procedure: Achilles Lengthening SurgeryParticipants will receive Achilles lengthening surgery, as usual care. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Achilles Lengthening 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. | Procedure or surgery | Achilles Lengthening Surgery |
Primary outcome
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)
Time frame: Pre-surgery / six months post-surgery / one year post-surgery
Quality of life tool
6 secondary outcomes
EuroQol 5 Dimensions Youth (EQ-5D-Y)
Time frame: Pre-surgery / six months post-surgery / one year post-surgery
Single heel rise test
Time frame: Pre-surgery / one year post-surgery
Ankle range of motion
Time frame: Pre-surgery / one year post-surgery
Single question
Time frame: Pre-surgery / six months post-surgery / one year post-surgery
Patient Reported Experience Measure (PREM)
Time frame: One year post-surgery
Three Dimensional Gait Analysis (3DGA)
Time frame: Pre-surgery / one year post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No. This was not included in the participant information sheets.
Related trials for Idiopathic Toe-walking
Recruiting
The Effect of Targeting the Plantaris Muscle-tendon in Surgical Correction of Ankle Equinus in Children
Idiopathic Toe Walking, Cerebral Palsy
Recruiting
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
Equinus Contracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil principal investigator
University of Oxford
Yael Gelfer, BSc, MD, PhD, FRCS study director
St George's University Hospitals NHS Foundation Trust
Julie Stebbins, DPhil SRCS CSci study director
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Toe-walking, run by University of Oxford at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen M Morrow, BSc. MSc. (+441865 227 607, Eileen.Morrow@ouh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) (time frame: Pre-surgery / six months post-surgery / one year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.