NCT07316985|Completed
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Sponsor study identifier
observational
72
1 country
1
Study Start
June 1, 2023
Actual (reported)Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)This observational study is designed to investigate the time-dynamic characteristics of gait variability in children with spastic cerebral palsy (SCP). A total of 36 children with SCP and 36 age-, sex-, and BMI-matched typically developing children are recruited from the Children's Rehabilitation Center of the Affiliated Hospital of Binzhou Medical University. Using a portable gait analysis system (IDEEA, Minisun, USA) and a wireless surface electromyography system (Delsys, USA), participants perform a 3-minute continuous walking test at a self-selected comfortable speed. Key spatiotemporal gait parameters and electromyographic root mean square (RMS) values of the tibialis anterior and gastrocnemius muscles are assessed at predefined time points (10 seconds, 1 minute, 2 minutes, and 3 minutes). This study aims to examine temporal changes in gait variability and muscle activation during continuous walking in children with SCP, with the objective of identifying potential time points that may inform the optimization of walking-rest intervals in rehabilitation training.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2023
Actual (reported)December 1, 2024
Actual (reported)December 31, 2024
Actual (reported)November 17, 2025
Actual (reported)January 5, 2026
Actual (reported)Change in Step Time
Step time was captured using the IDEEA 3.01 portable gait analysis system during a 3-minute continuous walking test. Step time values at 10 seconds, 1 minute, 2 minutes, and 3 minutes were compared to quantify temporal changes in gait variability in children with spastic cerebral palsy.
10 seconds, 1 minute, 2 minutes, 3 minutes
Change in EMG RMS of Tibialis Anterior (µV)
10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in EMG RMS of Gastrocnemius (µV)
3-minute continuous walking test
Change in Energy Expenditure (kCal/min)
10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in Stride Length (cm)
10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Cadence
10 seconds, 1 minute, 2 minutes, 3 minutes
Children diagnosed with spastic cerebral palsy (SCP) according to the Chinese Guidelines for Cerebral Palsy Rehabilitation (2022). Participants aged 3-6 years with Gross Motor Function Classification System (GMFCS) levels I-II performed a 3-minute continuous walking test at a self-selected comfortable speed. Gait and surface electromyography (EMG) parameters were collected to evaluate time-dependent gait variability and muscle activation patterns.
Age-, sex-, and BMI-matched typically developing children without neurological or musculoskeletal disorders. Participants performed the same 3-minute walking test protocol as the SCP group. Gait and surface electromyography data were used as reference values for comparison of spatiotemporal gait parameters and muscle activity changes over time.
Participants performed a 3-minute continuous walking test at a self-selected comfortable speed on a flat surface. Gait parameters were recorded using a portable gait analysis system (IDEEA 3.01, Minisun, USA), and bilateral tibialis anterior and gastrocnemius muscle activity was measured using a Delsys wireless surface EMG system. This standardized assessment procedure was applied to all participants to evaluate time-dependent gait variability and muscle activation patterns.
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Children aged 3 to 6 years diagnosed with spastic cerebral palsy (SCP) who were receiving rehabilitation therapy at the Children's Rehabilitation Center of the Affiliated Hospital of Binzhou Medical University, and age-, sex-, and BMI-matched healthy children without neurological or musculoskeletal disorders who served as controls.
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, 256603, China
72 participants (actual enrollment reported by the registry).
First Submitted
November 17, 2025
First Posted
January 5, 2026
Study Start
June 1, 2023
Actual (reported)Dynamic Surface Exercise and Trunk Targeted Training in Children With Spastic Cerebral Palsy
Contact the study team to confirm eligibility.
Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
March 27, 2026
Record last verified: 2026-03
De-identified individual participant data (IPD), including gait parameters, electromyography results, and energy expenditure values, will be available upon reasonable request after publication. Requests can be made to the corresponding author at the Affiliated Hospital of Binzhou Medical University. Data will be shared for academic research purposes only, in compliance with institutional and ethical regulations.
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Source: ClinicalTrials.gov.
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