Typically Developing ChildrenNCT05571501
Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
A study testing Gait assessment using the GAITRIte walkway in people with Typically Developing Children and Talipes Equino Varus, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Walking measurement in children is important but there are challenges associated with obtaining reliable repeatable data in a clinical setting that is meaningful and easy to interpret. This study set out to develop a new way to collect, record, and interpret walking data that is suitable for the clinical environment. Read more about this study
- Who is it for?
- Ages 10 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Typically Developing Children, Talipes Equino Varus, Paediatric Orthopaedic
- What is being tested?
- Gait assessment using the GAITRIte walkway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Oct 2015
- Phase
- Interventional
- 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 10 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Able to walk 100m
Who cannot join
- recent fracture or musculoskeletal injury which would affect gait
Trial locations and contacts
1 site in 1 country.
About this study
Walking measurement in children is important but there are challenges associated with obtaining reliable repeatable data in a clinical setting that is meaningful and easy to interpret. This study set out to develop a new way to collect, record, and interpret walking data that is suitable for the clinical environment. Developmental percentile charts were selected as they are widely recognised and easily interpreted.
Read the detailed description
The primary output of the main cohort of typically developing children is the developmental percentile charts.
These will be then used to present the clinical longitudinal data against a normal backdrop of developmental changes in children.
This has multiple clinical applications in many of the children assessed by physiotherapy at GOSH and more widely Nationally and internationally
- Conditions
- Typically Developing Children, Talipes Equino Varus, Paediatric Orthopaedic, Paediatric Neurological
- Being tested
- Gait assessment using the GAITRIte walkway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait assessment using the GAITRIte walkwayDevice
Also called GAITRite
10-20 walking assessment using the GAITRite walkway
| Study group | Role | What they receive |
|---|---|---|
| Typically developing children | Active comparator | 500 children aged 1-18 male and female will be recruited from local schools, after school clubs and playgroups.
Each child will complete a screening form following appropriate information and consent process. Each child will then complete the walking assessment which takes 15 minutes in total Receives: Device: Gait assessment using the GAITRIte walkway |
| Clinical groups | Active comparator | Children will be recruited through their patient journey. Families who consent to participation will complete the screening form and the GAITRite walking assessment as part of their pre-planned clinical followup in outpatient clinics.
One group of children will be assessed at one time point, whilst a second group of children with progressive orthopaedic conditions or treatment will be assessed at intervals to give longitudinal data Receives: Device: Gait assessment using the GAITRIte walkway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait data recorded via GAITRite software
Continuous numeric data summarising walking performance and characteristics
Measured: For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups
Secondary outcomes (1)
demographic and clinical outcome data
surgical history (where relevant)
Measured: 30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months
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 startMay 2012
- Primary completionAug 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Typically Developing ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The tool used for this study has been and was used for routine patient care, but was a novel diagnostic assessment for the typically developing (norms) and some of the clinical groups included. The clinical groups were compared to norms, both had the same diagnostic assessment so there was no control group who did not have the assessment
- Masking
- None (open label)
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GOSHCC
- Responsible party
- Sponsor
- Investigators
- Lucy Alderson, PhD, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571501
- Sponsor's protocol ID
- 10NS14
- Other IDs
- 11/LO/1889
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2015
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary centile charts for norms will be available with no individual identifiers
Publications
Wood M, Cleary MA, Alderson L, Vellodi A. Changes in gait pattern as assessed by the GAITRite walkway system in MPS II patients undergoing enzyme replacement therapy. J Inherit Metab Dis. 2009 Dec;32 Suppl 1:S127-35. doi: 10.1007/s10545-009-1103-2. Epub 2009 Mar 25.
PubMed 19319660Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite walkway. Haemophilia. 2007 Sep;13(5):542-7. doi: 10.1111/j.1365-2516.2007.01429.x.
PubMed 17880441Alderson LM, Joksaite SX, Kemp J, Main E, Watson T, Platt FM, Cortina-Borja M. Age-related gait standards for healthy children and young people: the GOS-ICH paediatric gait centiles. Arch Dis Child. 2019 Aug;104(8):755-760. doi: 10.1136/archdischild-2018-316311. Epub 2019 Mar 25.
PubMed 30910816
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
- Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
- ClinicalTrials.gov ID
- NCT05571501
- Acronym / sponsor ID
- 10NS14
- Conditions
- Typically Developing Children, Talipes Equino Varus, Paediatric Orthopaedic, Paediatric Neurological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GOSHCC
- Study start
- May 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (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.
Walking measurement in children is important but there are challenges associated with obtaining reliable repeatable data in a clinical setting that is meaningful and easy to interpret. This study set out to develop a new way to collect, record, and interpret walking data that is suitable for the clinical environment. Developmental percentile charts were selected as they are widely recognised and easily interpreted.
Detailed description
The primary output of the main cohort of typically developing children is the developmental percentile charts.
These will be then used to present the clinical longitudinal data against a normal backdrop of developmental changes in children.
This has multiple clinical applications in many of the children assessed by physiotherapy at GOSH and more widely Nationally and internationally
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The tool used for this study has been and was used for routine patient care, but was a novel diagnostic assessment for the typically developing (norms) and some of the clinical groups included. The clinical groups were compared to norms, both had the same diagnostic assessment so there was no control group who did not have the assessment
| Arm | Type | Receives |
|---|---|---|
| Typically developing children | Active comparator | Device: Gait assessment using the GAITRIte walkway500 children aged 1-18 male and female will be recruited from local schools, after school clubs and playgroups. Each child will complete a screening form following appropriate information and consent process. Each child will then complete the walking assessment which takes 15 minutes in total |
| Clinical groups | Active comparator | Device: Gait assessment using the GAITRIte walkwayChildren will be recruited through their patient journey. Families who consent to participation will complete the screening form and the GAITRite walking assessment as part of their pre-planned clinical followup in outpatient clinics. One group of children will be assessed at one time point, whilst a second group of children with progressive orthopaedic conditions or treatment will be assessed at intervals to give longitudinal data |
Who may qualify
- Ages
- 10 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Able to walk 100m
Key exclusion criteria (1 listed)
- recent fracture or musculoskeletal injury which would affect gait
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 |
|---|---|---|
| Gait assessment using the GAITRIte walkwayAlso: GAITRite10-20 walking assessment using the GAITRite walkway | Device | Clinical groups, Typically developing children |
Primary outcome
Gait data recorded via GAITRite software
Time frame: For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups
Continuous numeric data summarising walking performance and characteristics
1 secondary outcome
demographic and clinical outcome data
Time frame: 30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months
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.
- Background: PubMed 19319660Wood M, Cleary MA, Alderson L, Vellodi A. Changes in gait pattern as assessed by the GAITRite walkway system in MPS II patients undergoing enzyme replacement therapy. J Inherit Metab Dis. 2009 Dec;32 Suppl 1:S127-35. doi: 10.1007/s10545-009-1103-2. Epub 2009 Mar 25.
- Background: PubMed 17880441Bladen M, Alderson L, Khair K, Liesner R, Green J, Main E. Can early subclinical gait changes in children with haemophilia be identified using the GAITRite walkway. Haemophilia. 2007 Sep;13(5):542-7. doi: 10.1111/j.1365-2516.2007.01429.x.
- Results publication: PubMed 30910816Alderson LM, Joksaite SX, Kemp J, Main E, Watson T, Platt FM, Cortina-Borja M. Age-related gait standards for healthy children and young people: the GOS-ICH paediatric gait centiles. Arch Dis Child. 2019 Aug;104(8):755-760. doi: 10.1136/archdischild-2018-316311. Epub 2019 Mar 25.
- Individual participant dataSharing planned: No. Only summary centile charts for norms will be available with no individual identifiers
Related trials for Typically Developing Children
Recruiting
Repetitive Transcranial Magnetic Stimulation on Motor Function and Meta-Plasticity in Cerebral Palsy: TMS-EEG Study
Cerebral Palsy, Typically Developing Children
Not yet recruiting
Artificial Intelligence-Supported Digital Game and Exercise Applications in Children With Autism and Typically Developing Children
Autism Disorder
Not yet recruitingObservational study
Fine Motor Performance in School-aged Children
Healthy Children
Recruiting
Assessment of Language Comprehension and Learning in Children Attending Child Psychiatry Services (TICOALA-SOINS)
Typical Development, Typically Developing Children Ages 3 to 6
Active, not recruitingObservational study
Social Cognition in Children and Adolescents With Autism Spectrum Disorder
Autism
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.
Lucy Alderson, PhD 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?
A study testing Gait assessment using the GAITRIte walkway in people with Typically Developing Children and 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 1 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 data recorded via GAITRite software (time frame: For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups). 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 NCT05571501, which also lists 3 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.