Spastic Cerebral PalsyNCT07316985
Efficacy of Physical Fitness Training Combined With Exercise Therapy on Gait in Children With Cerebral Palsy
An observational study of Spastic Cerebral Palsy, run by LiNa Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- 3-Minute Walking Gait and Surface Electromyography Assessment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, 256603
About this study
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.
Read the detailed 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.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- 3-Minute Walking Gait and Surface Electromyography Assessment
- Keywords
- Gait Variability, Time-Dynamic Analysis, Surface Electromyography, Rehabilitation Training, Motor Function, Children, Spatiotemporal Gait Parameters
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-Minute Walking Gait and Surface Electromyography AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: 3-Minute Walking Gait and Surface Electromyography Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 seconds, 1 minute, 2 minutes, 3 minutes
Secondary outcomes (7)
Change in EMG RMS of Tibialis Anterior (µV)
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.
Measured: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in EMG RMS of Gastrocnemius (µV)
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.
Measured: 3-minute continuous walking test
Change in Energy Expenditure (kCal/min)
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.
Measured: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in Stride Length (cm)
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.
Measured: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Cadence
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.
Measured: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Stance Phase (% gait cycle)
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.
Measured: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Swing Phase
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.
Measured: 10 seconds, 1 minute, 2 minutes, 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- LiNa Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LiNa Zhang, Yantai Affiliated Hospital of Binzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316985
- Sponsor's protocol ID
- BZMC-SCP-GAIT-2023
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physical Fitness Training Combined With Exercise Therapy on Gait in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07316985
- Acronym / sponsor ID
- BZMC-SCP-GAIT-2023
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Gait Variability, Time-Dynamic Analysis, Surface Electromyography, Rehabilitation Training, Motor Function, Children, Spatiotemporal Gait Parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- LiNa ZhangUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spastic Cerebral Palsy Group | – | Other: 3-Minute Walking Gait and Surface Electromyography AssessmentChildren 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. |
| Healthy Control Group | – | Other: 3-Minute Walking Gait and Surface Electromyography AssessmentAge-, 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-Minute Walking Gait and Surface Electromyography AssessmentParticipants 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. | Other | Healthy Control Group, Spastic Cerebral Palsy Group |
Primary outcome
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.
7 secondary outcomes
Change in EMG RMS of Tibialis Anterior (µV)
Time frame: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in EMG RMS of Gastrocnemius (µV)
Time frame: 3-minute continuous walking test
Change in Energy Expenditure (kCal/min)
Time frame: 10 seconds, 1 minute, 2 minutes, and 3 minutes after walking initiation
Change in Stride Length (cm)
Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Cadence
Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Stance Phase (% gait cycle)
Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes
Change in Swing Phase
Time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Cerebral Palsy, run by LiNa Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Step Time (time frame: 10 seconds, 1 minute, 2 minutes, 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.