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

NCT07316985 | Completed

• 1 other identifier: BZMC-SCP-GAIT-2023
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spastic Cerebral Palsy

Keywords

Gait Variability; Time-Dynamic Analysis; Surface Electromyography; Rehabilitation Training; Motor Function; Children; Spatiotemporal Gait Parameters

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

Spastic Cerebral Palsy Group

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.

Other: 3-Minute Walking Gait and Surface Electromyography Assessment

Healthy Control Group

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.

Other: 3-Minute Walking Gait and Surface Electromyography Assessment

Interventions

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.

Healthy Control Group; Spastic Cerebral Palsy Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LiNa Zhang: lead

Study Sites (1)

Affiliated Hospital of Binzhou Medical University

Binzhou, Shandong, 256603, China

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 5, 2026
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD), including gait parameters, electromyography results, and energy expenditure values, together with the study protocol, statistical analysis plan, and analytic code, will be available beginning 6 months after publication of the primary results and will remain accessible for 3 years. Data will be provided to qualified researchers upon reasonable request and institutional approval through a controlled access process managed by the Affiliated Hospital of Binzhou Medical University.
• Access Criteria: Qualified researchers affiliated with academic or non-profit institutions may request access to de-identified individual participant data (IPD) and supporting materials, including the study protocol, statistical analysis plan, and analytic code. Data requests must include a brief proposal describing the intended use and will be reviewed by the Institutional Ethics Committee of the Affiliated Hospital of Binzhou Medical University. Upon approval, data will be shared through a secure institutional data-sharing platform. All shared data will be de-identified and used exclusively for academic research in compliance with institutional and ethical regulations.

Locations

CN (1)