Clinical trial NCT05571501: Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
Official title: Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Typically Developing Children
Talipes Equino Varus
Paediatric Orthopaedic
Paediatric Neurological
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: GOSHCC
First posted: 2022-10-07
Enrollment: 702
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Eligibility criteria: Inclusion Criteria:

* Able to walk 100m

Exclusion Criteria:

* recent fracture or musculoskeletal injury which would affect gait

Primary outcomes:
measure: Gait data recorded via GAITRite software
timeFrame: For the duration of the study measured once for typically developing and at multiple clinic visits over 24 months for clinical groups
Secondary outcomes:
measure: demographic and clinical outcome data
timeFrame: 30 to 60 mins to collect relevant data at a single time point, with an update to include additional admissions over 24months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Lucy Alderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.