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CompletedNCT05572411Updated Oct 7, 2022

Gait Analysis in Idiopathic Clubfoot Patients Treated by the Ponseti Method

An observational study in Congenital Talipes Equino Varus, sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 12 Months to 7 Years. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
20
Ages
12 Months to 7 Years
Sex
All
01

Study summary

The purpose of this study is to assess the walking pattern of clubfoot patients using a pressure sensing walkway, and investigate whether any of the data produced can be used to detect the early signs of relapse in their foot posture.

Read the detailed description

Study Background:

A series of studies have used the GAITRite Electronic Walkway to collect normative data with more than 500 typically developing children between the ages of 1 - 18 years of age. The data was used to produce novel normative gait related percentile charts. These charts provide an immediate reference against which individual scores can be plotted and improvements demonstrated. Their value in the clinical setting was demonstrated by the inclusion of a variety of clinical diagnoses which all have the ability to affect the gait pattern. One clinical group consisted of Ponseti treated Idiopathic Clubfoot patients.

Gait is an important functional milestone for all children, particularly if the child has undergone treatment to produce a functional foot position which will allow them to engage in normal childhood activities with minimal pain and discomfort. Treatment concepts in Clubfoot are centred on non-operative techniques where the outcome is improved by avoiding the scar tissue associated with surgical releases. Gait analysis results at medium and long term intervals support the improved functional ability following non-operative intervention however infrequent analysis has resulted in a lack of longitudinal gait analysis in the Clubfoot population. Such information would give an insight into the development of gait in the presence of a corrected deformity being challenged by the rapid growth of the child.

The gait analysis systems used in many of the published research are complex, expensive and require specialised skills to operate, presenting many barriers to performing regular gait analysis. In contrast, the GAITRite is a relatively inexpensive, portable, child friendly system which allows for frequent gait analysis, producing Temporo-spatial data, easily extracted and interpreted by the clinician. From the longitudinal data we would be able to study the development of gait and pressure patterns within this patient population, investigating whether particular parameters or trends exist that are indicative of relapse in foot posture, aiding early identification and implementation of treatment.

Aims and Objectives:

The aim of this research project is to incorporate gait analysis with the GAITRite electronic walkway into the assessment of patients attending the GOSH Ponseti clinic. This will provide on-going information regarding the development of gait and response of the deformity correction to growth in these patients.

The objective is to analyse the data and determine if it is possible to identify common clinical measures which will help determine patients at greater risk of relapse.

Practical Details:

Ambulant patients who have received Ponseti treatment for Idiopathic CTEV will be identified through the GOSH Ponseti clinic and invited to participate in the study.

As part of their assessment at each appointment, height, weight and leg length data will be measured and the participants will be asked to walk across the 6m pressure sensing walkway. Depending on the age of the child and ability to follow instruction, the participant will be asked to walk at self-selected, fast and slow speed, with 4 repetitions at each one. The participant will start walking 2m before the walkway and continue 2m after it, to allow for recording of a steady gait. The process takes approximately 15 minutes per child.

Data Collection/Storage:

The personal data required for each participant is their name and date of birth. These will be collected in paper form on the consent and screening form, after which the participant will be assigned a study number and be referred to as such in collecting and storing electronic data. All manual forms will be securely stored in a locked cabinet on Trust premises in line with the Trust policy for storing patient records.

With regards to the electronic data, as previously stated, participants will be identified by number rather than name. The Gaitrite data initially be stored on a laptop but will be uploaded as soon as possible to the Trust server and the laptop data being removed by the appropriate means. Access to the Gaitrite and Trust server is via log in and individual password.

02

Conditions studied

  • Congenital Talipes Equino Varus

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Keywords

  • CTEV
  • Clubfoot
03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's enrollment of 20 is below the median of 55 across 27 observational studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust is the lead sponsor of 82 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of Idiopathic Congenital Talipes Equinovarus patients who received the Ponseti Method for management of their deformity.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Idiopathic Congenital Talipes Equinovarus
  • Received Ponseti method for management of their deformity.
  • Ambulant

Exclusion criteria

Exclusion Criteria:

  • Syndromic Clubfoot
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Ponseti

    Ponseti treated Clubfoot participants will be asked to walk across the GAITRite Electronic Walkway.

    Other: GAITRite Electronic Walkway

Interventions

  • OtherGAITRite Electronic Walkway

    Participants will be asked to walk across the electronic walkway to record information relating to their gait pattern. Depending on the age and compliance of the participant, they will be asked to complete 3 passes at 3 speeds, preferred, fast and slow.

06

What researchers measure

Primary outcomes

  1. Gait Related Relapse Indicator

    Assessment in clinic GAITRite electronic walkway is able to identify specific gait parameters which suggest deterioration in the correction achieved with the initial Ponseti management, these will be presented as a way of combining clinical assessment with instrumented gait analysis for thorough evaluation of the patients progress.

    Time frame: Bi-annually for duration of follow-up at GOSH between 2-7 years

07

Study locations

1 site
  • Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
08

References and documents

Publications

  • Eastwood, D., Alderson, LM, Kemp J. Measuring consistency of gait performance over 3 speeds with Ponseti Treated Club foot patients. J Child Orthopaedics. 2015. (S12) 9 Suppl1: S11-S5
  • EPOS 34th Annual Meeting. J Child Orthop. 2015 Apr;9(Suppl 1):11-56. doi: 10.1007/s11832-015-0637-0. No abstract available. PubMed 25754189 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Mar 2016, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2022
First posted
Oct 7, 2022
StartActual
Mar 2015
Primary completionActual
Mar 2016
CompletionActual
Sep 2016
Last update
Oct 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05572411
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
Mar 2015
Primary completion
Mar 2016
Completion
Sep 2016
Last update
Oct 7, 2022

Study contacts

Jennifer Kemp, Bsc (Hons)
principal investigator · Great Ormond Street Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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