Gait Analysis in Idiopathic Clubfoot Patients Treated by the Ponseti Method
Condition: Congenital Talipes Equino Varus
MeSH terms: Clubfoot; Talipes; Equinus Deformity
Study type: Observational

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.
    

Intervention name(s): GAITRite Electronic Walkway
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Prospective
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.
      
Keywords: CTEV; Clubfoot