Congenital Talipes Equino VarusNCT05572411
Gait Analysis in Idiopathic Clubfoot Patients Treated by the Ponseti Method
An observational study of Congenital Talipes Equino Varus, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 more about this study
- Who is it for?
- Ages 12 months to 7 years
- Conditions the study is for
- Congenital Talipes Equino Varus
- What is being tested?
- GAITRite Electronic Walkway
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Sep 2016
- 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 12 months to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will consist of Idiopathic Congenital Talipes Equinovarus patients who received the Ponseti Method for management of their deformity.
Who may be able to join
- Idiopathic Congenital Talipes Equinovarus
- Received Ponseti method for management of their deformity.
- Ambulant
Who cannot join
- Syndromic Clubfoot
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Analysis With Idiopathic Clubfoot Patients Treated by the Ponseti Method: Can Regular Assessment With the GAITRite Walkway Identify Common Gait Changes in Relapsing Patients?
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.
- Conditions
- Congenital Talipes Equino Varus
- Being tested
- GAITRite Electronic Walkway
- Keywords
- CTEV, Clubfoot
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAITRite Electronic WalkwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ponseti | Ponseti treated Clubfoot participants will be asked to walk across the GAITRite Electronic Walkway. Receives: Other: GAITRite Electronic Walkway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Bi-annually for duration of follow-up at GOSH between 2-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study startMar 2015
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Talipes Equino VarusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Kemp, Bsc (Hons), Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572411
- Sponsor's protocol ID
- 13NS23
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis With Idiopathic Clubfoot Patients Treated by the Ponseti Method: Can Regular Assessment With the GAITRite Walkway Identify Common Gait Changes in Relapsing Patients?
- ClinicalTrials.gov ID
- NCT05572411
- Acronym / sponsor ID
- 13NS23
- Conditions
- Congenital Talipes Equino Varus
- Keywords
- CTEV, Clubfoot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Oct 2022 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ponseti | – | Other: GAITRite Electronic WalkwayPonseti treated Clubfoot participants will be asked to walk across the GAITRite Electronic Walkway. |
Who may qualify
- Ages
- 12 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of Idiopathic Congenital Talipes Equinovarus patients who received the Ponseti Method for management of their deformity.
Key inclusion criteria (3 listed)
- Idiopathic Congenital Talipes Equinovarus
- Received Ponseti method for management of their deformity.
- Ambulant
Key exclusion criteria (1 listed)
- Syndromic Clubfoot
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 |
|---|---|---|
| GAITRite Electronic WalkwayParticipants 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. | Other | Ponseti |
Primary outcome
Gait Related Relapse Indicator
Time frame: Bi-annually for duration of follow-up at GOSH between 2-7 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Results publicationEastwood, 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
- Results publication: PubMed 25754189EPOS 34th Annual Meeting. J Child Orthop. 2015 Apr;9(Suppl 1):11-56. doi: 10.1007/s11832-015-0637-0. No abstract available.
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.
Jennifer Kemp, Bsc (Hons) principal investigator
Great Ormond Street Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Talipes Equino Varus, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Related Relapse Indicator (time frame: Bi-annually for duration of follow-up at GOSH between 2-7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572411, which also lists 2 linked publications.
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 7 Oct 2022.