Back to resultsMeasuring Normal and Impaired Walking in Children Using the GAITRite Walkway
Primary Purpose
Typically Developing Children, Talipes Equino Varus, Paediatric Orthopaedic
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gait assessment using the GAITRIte walkway
Sponsored by
About this trial
This is an interventional diagnostic trial for Typically Developing Children
Eligibility Criteria
Inclusion Criteria:
- Able to walk 100m
Exclusion Criteria:
- recent fracture or musculoskeletal injury which would affect gait
Sites / Locations
- Great Ormond Street Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Typically developing children
Clinical groups
Arm Description
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
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
Outcomes
Primary Outcome Measures
Gait data recorded via GAITRite software
Continuous numeric data summarising walking performance and characteristics
Secondary Outcome Measures
demographic and clinical outcome data
surgical history (where relevant)
Full Information
NCT ID
NCT05571501
First Posted
April 23, 2015
Last Updated
October 6, 2022
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
GOSHCC
1. Study Identification
Unique Protocol Identification Number
NCT05571501
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
GOSHCC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typically Developing Children, Talipes Equino Varus, Paediatric Orthopaedic, Paediatric Neurological
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Masking Description
All children recruited underwent the GAITRite assessment
Allocation
Non-Randomized
Enrollment
702 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Typically developing children
Arm Type
Active Comparator
Arm Description
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
Arm Title
Clinical groups
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Gait assessment using the GAITRIte walkway
Other Intervention Name(s)
GAITRite
Intervention Description
10-20 walking assessment using the GAITRite walkway
Primary Outcome Measure Information:
Title
Gait data recorded via GAITRite software
Description
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 Outcome Measure Information:
Title
demographic and clinical outcome data
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able to walk 100m
Exclusion Criteria:
recent fracture or musculoskeletal injury which would affect gait
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Alderson, PhD
Organizational Affiliation
Great Ormond Street Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only summary centile charts for norms will be available with no individual identifiers
Citations:
PubMed Identifier
19319660
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.
Results Reference
background
PubMed Identifier
17880441
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.
Results Reference
background
PubMed Identifier
30910816
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.
Results Reference
result
Learn more about this trial
Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
We'll reach out to this number within 24 hrs