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CompletedNCT05571501Updated Oct 7, 2022

Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway

An interventional study of Gait assessment using the GAITRIte walkway in Typically Developing Children, Talipes Equino Varus and Paediatric Orthopaedic, sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 10 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
702
Allocation
Non-randomized
Ages
10 Months to 18 Years
Sex
All
01

Study 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. 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

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Conditions studied

  • Typically Developing Children
  • Talipes Equino Varus
  • Paediatric Orthopaedic
  • Paediatric Neurological

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03

In context

Talipes

2 studies on the registry are indexed under Talipes; none are open to participants now.

Browse Talipes 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
10 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Able to walk 100m

Exclusion criteria

Exclusion Criteria:

  • recent fracture or musculoskeletal injury which would affect gait
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
702 participants (actual)

Study arms

  • Active comparator
    Typically developing children

    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

    Device: Gait assessment using the GAITRIte walkway

  • Active comparator
    Clinical groups

    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

    Device: Gait assessment using the GAITRIte walkway

Interventions

  • DeviceGait assessment using the GAITRIte walkway

    10-20 walking assessment using the GAITRite walkway

    Also known as: GAITRite

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What researchers measure

Primary outcomes

  1. Gait data recorded via GAITRite software

    Continuous numeric data summarising walking performance and characteristics

    Time frame: 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)

    Time frame: 30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months

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Study locations

1 site
  • Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
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References and documents

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 19319660 ↗
  • Bladen 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 17880441 ↗
  • Alderson 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 ↗

Individual participant data

Plan to share: No — Only summary centile charts for norms will be available with no individual identifiers

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2012, a primary completion of Aug 2015 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.

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

Registered
Apr 23, 2015
First posted
Oct 7, 2022
Start
May 2012
Primary completionActual
Aug 2015
CompletionActual
Oct 2015
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 ↗
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Registry details

Key details

Study ID
NCT05571501
Lead sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
GOSHCC
Responsible party
Sponsor
First posted
Oct 7, 2022
Start date
May 2012
Primary completion
Aug 2015
Completion
Oct 2015
Last update
Oct 7, 2022

Study contacts

Lucy Alderson, PhD
principal investigator · Great Ormond Street Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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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