Repeatability of Gait Deviations in Children With Cerebral Palsy

NCT06355869 | Completed

• 1 other identifier: s65337
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill.

Conditions

Spastic Cerebral Palsy

Keywords

Cerebral Palsy; Rehabilitation; Gait analysis; Variability

Outcome Measures

Primary Outcomes (4)

• The standard error of measurement (SEM) of the continuous kinematic gait waveforms

  The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations\^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinematic continuous waveforms in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. \[4\]

  A period of 1-14 days is foreseen between the two measurements (3DGA)

• The intra-class correlation (ICC) of the gait indices

  The inter-trial and -session variability was defined by the use of the intra-class correlation coefficient (ICC; 2,1) (two-way random model with absolute agreement), along with the 95% confidence interval of the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion).

  A period of 1-14 days is foreseen between the two measurements (3DGA)

• The standard error of measurement (SEM) of the continuous kinetic gait waveforms

  The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= √((∑▒〖deviations\^2 〗)/(degrees of freedom)). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement. This characteristic makes the use of SEM particularly clinically relevant. The SEM was used as a statistical analysis for determining the inter-trial and -session variability of the kinetic continuous waveforms (i.e., moments \& powers) in the sagittal plane of the hip, knee and ankle joint. Thereby, the SEM was calculated timepoint-by-timepoint from the continues waveforms, according to the methods of Schwartz et al. \[4\]

  A period of 1-14 days is foreseen between the two measurements (3DGA)

• The standard error of measurement (SEM) of the gait indices

  The SEM, is the standard deviation of a number of measurements made on the same participant. SEM= SD x √(1-ICC), where SD is the standard deviation of the grand mean (mean of session 1 and session 2) from all participants. The SEM was calculated for the gait indices (i.e., the gait profile score and the gait variable score of the hip flexion, the knee flexion and the ankle dorsiflexion). The primary advantage of the SEM lies in providing a direct indication of measurement error in the same units as the original measurement, which makes the use of SEM particularly clinically relevant.

  A period of 1-14 days is foreseen between the two measurements (3DGA)

Study Arms (2)

Ambulatory children with spastic CP

Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.

Other: repeated 3D gait-analysis

TD children

Our TD-database of the Clinical Motion Analysis Laboratory (CMAL) of UZ Leuven was used for the calculation of the gait indices.

Interventions

repeated 3D gait-analysis OTHER

An observational 3D gait-analysis was performed with a period of 1-14 days is foreseen between the two measurements.

Ambulatory children with spastic CP

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.

You may qualify if:

• Gross Motor Function Classification System (GMFCS) level I - III
• CP (bilateral \& unilateral)
• Age: 6 - 17 years
• Prescribed AFO by the medical team (as part of the standard care)

You may not qualify if:

• Severe contractures or spasticity, which makes it impossible to wear a conventional AFO
• Cognitive or visual impairment that hinder them to understand instructions
• Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
• Presence of ataxia or dystonia

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (5)

• Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.

  PMID: 27188686 BACKGROUND

• Sankar C, Mundkur N. Cerebral palsy-definition, classification, etiology and early diagnosis. Indian J Pediatr. 2005 Oct;72(10):865-8. doi: 10.1007/BF02731117.

  PMID: 16272660 BACKGROUND

• Morris C, Bowers R, Ross K, Stevens P, Phillips D. Orthotic management of cerebral palsy: recommendations from a consensus conference. NeuroRehabilitation. 2011;28(1):37-46. doi: 10.3233/NRE-2011-0630.

  PMID: 21335676 BACKGROUND

• Schwartz MH, Trost JP, Wervey RA. Measurement and management of errors in quantitative gait data. Gait Posture. 2004 Oct;20(2):196-203. doi: 10.1016/j.gaitpost.2003.09.011.

  PMID: 15336291 BACKGROUND

• Everaert L, Dewit T, Huenaerts C, Van Campenhout A, Labey L, Desloovere K. Repeatability of gait of children with spastic cerebral palsy in different walking conditions. J Biomech. 2024 Nov;176:112301. doi: 10.1016/j.jbiomech.2024.112301. Epub 2024 Aug 31.

  PMID: 39265255 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kaat Desloovere, prof. dr.

  Department of Rehabilitation Sciences, KU Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: August 17, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

BE (1)