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Completed

NCT Number: NCT07316985

Efficacy of Physical Fitness Training Combined With Exercise Therapy on Gait in Children With Cerebral Palsy

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Binzhou Medical University

Binzhou, Shandong, 256603, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

3-Minute Walking Gait and Surface Electromyography Assessment

Other

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.

Primary outcomes

  1. Change in Step Time

    Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes

    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.

Secondary outcomes

  1. Change in EMG RMS of Tibialis Anterior (µV)

    Time frame: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation

    Surface EMG signals of the tibialis anterior were collected using a Delsys wireless EMG system during the walking test. RMS amplitude was calculated at 10 seconds, 1 minute, 2 minutes, and 3 minutes to evaluate time-dependent changes in muscle activation.

  2. Change in EMG RMS of Gastrocnemius (µV)

    Time frame: 3-minute continuous walking test

    Surface EMG activity of the gastrocnemius muscle was recorded using the Delsys EMG system. RMS values at each of the four time points were compared to assess fatigue-related reductions in muscle activation during continuous walking.

  3. Change in Energy Expenditure (kCal/min)

    Time frame: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation

    Energy expenditure was estimated by the IDEEA 3.01 gait system throughout the 3-minute walking task. Temporal changes in metabolic cost were used to assess walking efficiency and fatigue accumulation.

  4. Change in Stride Length (cm)

    Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes

    Stride length was recorded using the IDEEA 3.01 device at 10 seconds, 1 minute, 2 minutes, and 3 minutes. Changes over time reflect alterations in walking stability and fatigue-related gait adaptations.

  5. Change in Cadence

    Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes

    Cadence was measured at four time points during the walking test. Temporal differences were analyzed to characterize dynamic gait rhythm changes associated with spastic cerebral palsy.

  6. Change in Stance Phase (% gait cycle)

    Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes

    The percentage of the gait cycle spent in stance phase was calculated from IDEEA 3.01 data at 10 seconds, 1 minute, 2 minutes, and 3 minutes. Increased stance duration indicates impaired dynamic stability and early fatigue.

  7. Change in Swing Phase

    Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes

    Swing phase duration as a percentage of the gait cycle was measured at four predefined time points. Reduced swing phase was used as an indicator of compensatory gait adjustments during prolonged walking.

Sponsors and collaborators

Lead sponsor

Lina Zhang

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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