Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway

October 6, 2022 updated by: Great Ormond Street Hospital for Children NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

702

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to walk 100m

Exclusion Criteria:

  • recent fracture or musculoskeletal injury which would affect gait

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
10-20 walking assessment using the GAITRite walkway
Other Names:
  • GAITRite
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
10-20 walking assessment using the GAITRite walkway
Other Names:
  • GAITRite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
surgical history (where relevant)
30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Collaborators

GOSHCC

Investigators

  • Principal Investigator: Lucy Alderson, PhD, Great Ormond Street Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10NS14
  • 11/LO/1889 (Other Identifier: NRES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only summary centile charts for norms will be available with no individual identifiers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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