Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway

NCT05571501 | Completed

• 2 other identifiers: 10NS1411/LO/1889
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Gait data recorded via GAITRite software

  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 Outcomes (1)

• demographic and clinical outcome data

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

Study Arms (2)

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

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

Device: Gait assessment using the GAITRIte walkway

Interventions

Gait assessment using the GAITRIte walkway DEVICE

10-20 walking assessment using the GAITRite walkway

Also known as: GAITRite

Clinical groups; Typically developing children

Eligibility Criteria

• Age: 10 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to walk 100m

You may not qualify if:

• recent fracture or musculoskeletal injury which would affect gait

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• GOSHCC: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 19319660 BACKGROUND

• 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.

  PMID: 17880441 BACKGROUND

• 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.

  PMID: 30910816 RESULT

Study Officials

• Lucy Alderson, PhD

  Great Ormond Street Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All children recruited underwent the GAITRite assessment
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: October 7, 2022
• Study Start: May 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)