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Time-Dynamic Analysis of Gait Variability in Children With Spastic Cerebral Palsy ( SCP-TIME )

L

LiNa Zhang

Status

Completed

Conditions

Spastic Cerebral Palsy

Treatments

Other: 3-Minute Walking Gait and Surface Electromyography Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT07316985
BZMC-SCP-GAIT-2025

Details and patient eligibility

About

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.

Full description

Spastic cerebral palsy (SCP) is the most common type of cerebral palsy and is characterized by increased muscle tone and impaired motor coordination. Gait variability reflects the dynamic stability and adaptive responses of the locomotor system during walking and is considered an important indicator for functional performance and rehabilitation planning. Understanding how gait parameters and muscle activation patterns evolve over time during continuous walking is essential for designing safe and effective rehabilitation programs for children with SCP. However, the temporal evolution of gait variability during sustained walking in this population remains insufficiently characterized.

This prospective observational case-control study enrolls a total of 72 participants, including 36 children diagnosed with SCP (Gross Motor Function Classification System levels I-II) and 36 typically developing children matched by age, sex, and body mass index. All participants perform a 3-minute continuous walking test at a self-selected comfortable speed on a flat surface.

Spatiotemporal gait parameters are recorded using a portable gait analysis system (IDEEA 3.01, Minisun, USA), while bilateral muscle activity of the tibialis anterior and gastrocnemius muscles is recorded using a Delsys wireless surface electromyography (EMG) system. Gait parameters include step time, cadence, stride length, stance phase, swing phase, gait cycle, and foot lift angle. Surface EMG signals are processed to obtain root mean square (RMS) values as indicators of muscle activation amplitude. Energy expenditure during walking is also estimated using the gait analysis system.

All gait, EMG, and energy expenditure measurements are obtained at predefined time points during the walking task, specifically at 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation. Data analysis is performed using SPSS version 26.0. Between-group comparisons and within-group time-series comparisons are conducted according to data distribution characteristics.

By systematically assessing spatiotemporal gait parameters, muscle activation patterns, and energy expenditure across multiple time points during continuous walking, this study aims to explore the temporal evolution of gait variability in children with spastic cerebral palsy. The results of this study are intended to provide objective data that may inform the development of appropriate walking-rest strategies and individualized rehabilitation programs to support walking safety and functional endurance in children with SCP.

Enrollment

72 patients

Sex

All

Ages

3 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Children diagnosed with spastic cerebral palsy (SCP) according to the Chinese Guidelines for Cerebral Palsy Rehabilitation (2022).
  2. Gross Motor Function Classification System (GMFCS) levels I-II.
  3. Aged between 3 and 6 years.
  4. Able to understand and follow verbal instructions.
  5. Informed consent obtained from parents or legal guardians.

Exclusion criteria

  1. Inability to cooperate with gait or EMG testing.
  2. Presence of visual or hearing impairments.
  3. History of severe epilepsy or other systemic diseases.
  4. Received botulinum toxin or antispastic medication within the past 6 months.
  5. Incomplete gait data or failure to complete the walking test.
  6. For healthy controls: any neurological, orthopedic, or musculoskeletal disorder, or recent trauma affecting gait.

Trial design

72 participants in 2 patient groups

Spastic Cerebral Palsy Group
Description:
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.
Treatment:
Other: 3-Minute Walking Gait and Surface Electromyography Assessment
Healthy Control Group
Description:
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.
Treatment:
Other: 3-Minute Walking Gait and Surface Electromyography Assessment

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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