Gait Analysis in Idiopathic Clubfoot Patients Treated by the Ponseti Method

NCT ID: NCT05572411

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

Brief 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.

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.

Conditions

Congenital Talipes Equino Varus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ponseti

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

GAITRite Electronic Walkway

Intervention Type: OTHER

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.

Interventions

GAITRite 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Syndromic Clubfoot

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Kemp, Bsc (Hons)

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Locations

Great Ormond Street Hospital

London, , United Kingdom

Countries

United Kingdom

References

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

Reference Type: RESULT

EPOS 34th Annual Meeting. J Child Orthop. 2015 Apr;9(Suppl 1):11-56. doi: 10.1007/s11832-015-0637-0. No abstract available.

Reference Type: RESULT

PMID: 25754189 (View on PubMed)

Other Identifiers

13NS23

Identifier Type: -

Identifier Source: org_study_id