Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway

NCT ID: NCT05571501

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

702 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Typically Developing Children Talipes Equino Varus Paediatric Orthopaedic Paediatric Neurological

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

All children recruited underwent the GAITRite assessment

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Gait assessment using the GAITRIte walkway

Intervention Type DEVICE

10-20 walking assessment using the GAITRite walkway

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

Group Type ACTIVE_COMPARATOR

Gait assessment using the GAITRIte walkway

Intervention Type DEVICE

10-20 walking assessment using the GAITRite walkway

Interventions

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Gait assessment using the GAITRIte walkway

10-20 walking assessment using the GAITRite walkway

Intervention Type DEVICE

Other Intervention Names

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GAITRite

Eligibility Criteria

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Inclusion Criteria

* Able to walk 100m

Exclusion Criteria

* recent fracture or musculoskeletal injury which would affect gait
Minimum Eligible Age

10 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GOSHCC

UNKNOWN

Sponsor Role collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucy Alderson, PhD

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Locations

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Great Ormond Street Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 19319660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17880441 (View on PubMed)

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.

Reference Type RESULT
PMID: 30910816 (View on PubMed)

Other Identifiers

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11/LO/1889

Identifier Type: OTHER

Identifier Source: secondary_id

10NS14

Identifier Type: -

Identifier Source: org_study_id

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