Cerebral PalsyNCT07061275
Telehealth-Supervised Resistance Training for Children With Cerebral Palsy
A study testing Telehealth-Supervised Resistance Training in people with Cerebral Palsy, run by Hunan Normal University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the feasibility and potential benefits of telehealth-supervised resistance training in ambulatory children aged 6 to 15 years with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I-III. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Telehealth-Supervised Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Mar 2026
- Phase
- Interventional
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS levels I, II, or III;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
Who cannot join
- Aged under 6 years or over 15 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telehealth-Supervised Resistance Training to Improve Functional Capacity and Muscle Strength in Children With Cerebral Palsy: Protocol for a Single-Arm Intervention Study
The goal of this clinical trial is to evaluate the feasibility and potential benefits of telehealth-supervised resistance training in ambulatory children aged 6 to 15 years with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I-III.
The main questions it aims to answer are:
Read more
- Is a 12-week telehealth-delivered resistance training program feasible and acceptable for children with CP and their caregivers?
- Can the program improve physical function and psychosocial well-being in this population?
Participants will:
- Take part in three 40-minute, live-streamed resistance training sessions each week for 12 weeks, using elastic bands, sandbag weights, and balance tools
- Complete physical assessments before and after the program, including the 1-minute walk test, 10-meter walk test, 30-second sit-to-stand test, and Pediatric Balance Scale
- Complete quality of life surveys using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 CP Module)
- Have caregivers complete a custom questionnaire about the cost and acceptability of the program
Read the detailed description
Cerebral palsy (CP) is a lifelong neurodevelopmental disorder caused by non-progressive disturbances in the developing fetal or infant brain. It is characterized by impairments in movement and posture, often accompanied by disturbances in sensation, perception, cognition, communication, and behavior. Globally, CP affects an estimated 17 million individuals, with a birth prevalence of approximately 2 to 2.5 per 1,000 live births . In China, more than 6 million children are estimated to be living with CP, and approximately 40,000 new cases occur each year.
Motor impairments in CP often lead to compromised gross motor function, altered gait mechanics, and reduced muscle force generation. These deficits significantly impact daily living activities, including walking, stair climbing, and performing transitions such as standing from a seated position. Muscle weakness, in particular, is a primary contributor to poor mobility and reduced participation in community and educational settings. Children with Gross Motor Function Classification System (GMFCS) levels I-III are ambulatory but may still experience fatigue, slow gait speed, or difficulty in navigating uneven terrain. Resistance training has gained empirical support as an effective intervention for improving muscle strength, joint stability, and gross motor function in children with mild CP. As highlighted in our recent meta-analysis, a growing body of evidence from randomized controlled trials indicates that well-structured, progressive resistance training programs lead to measurable improvements in lower-limb muscle morphology, which is directly related to strength, walking performance, and motor control. Ultimately, these muscle adaptations are closely linked to gains in functional independence, including stair climbing, transitions, and longer walking endurance - activities essential for participation in home, school, and recreational settings.
Despite its proven efficacy, access to therapist-supervised or facility-based resistance training remains limited for many families - particularly those living in low-resource or rural settings. Children with CP are disproportionately represented among lower-income households, and socioeconomic factors can severely limit access to regular rehabilitation services. Out-of-pocket expenses for transportation, time off work for caregivers, and session fees create significant burdens, contributing to inadequate adherence and suboptimal rehabilitation outcomes.
Telehealth has emerged as a promising strategy to overcome these barriers by delivering structured, therapist-guided interventions remotely. The expansion of digital health technologies, particularly during the COVID-19 pandemic, has accelerated the adoption of tele-rehabilitation for various clinical populations. Live-streamed and app-based exercise training programs have shown promise in able-bodied populations due to their low cost, flexibility, and minimal infrastructure requirements. For children with CP, a telehealth model may increase access and engagement while reducing logistical and financial strain on families.
To our knowledge, no published studies have systematically evaluated the effects of telehealth-supervised resistance training specifically targeting improvements in functional capacity among children with CP. Given the affordability of this model - tele-exercise classes may cost as little as 10 CNY per session, and home exercise kits can be assembled using low-cost elastic bands and resistance tools - this approach may provide a viable, family-centered solution. The model is particularly attractive in the context of China and other low- and middle-income countries, where rehabilitation access is highly variable and often concentrated in urban centers.
The present study aims to evaluate the feasibility and efficacy of a telehealth-supervised resistance training program targeting lower-limb muscle strength and functional capacity in children with mild CP. This single-arm intervention trial will examine changes in gross motor ability, lower-limb muscle function, and parent-reported outcomes following a 3-month remotely supervised exercise protocol. The findings will provide initial evidence to inform the scalability and cost-effectiveness of telehealth-based rehabilitation models and may offer an inclusive and sustainable approach for pediatric rehabilitation in socioeconomically disadvantaged settings.
- Conditions
- Cerebral Palsy
- Being tested
- Telehealth-Supervised Resistance Training
- Keywords
- balance, cost, exercise training, gait, group exercise, rehabilitation, strength training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-Supervised Resistance TrainingBehavioural
The exercise protocol will incorporate a variety of exercise modalities adapted for home use in limited space environments. Elastic resistance bands will be used for lower-limb strength exercises such as leg presses, hip abduction, and ankle dorsiflexion, while sandbag-style leg weights will be employed for activities including knee extensions, seated marches, and standing squats. To target balance, low-cost tools such as foam pads, balance cushions, or step platforms will be used for tasks including static standing, single-leg stance, and step-up exercises designed to challenge postural control in a safe, progressive manner.
Sessions will be delivered through a secure live-streaming platform accessible on smartphones. The streaming platform supports background audio, allowing exercise sessions to be accompanied by music, which may help increase motivation and enjoyment for participating children. Each session will be led by trained instructors from the Hunan Normal University.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth-Supervised Resistance Training | Experimental | The intervention consists of a 12-week telehealth-supervised resistance training program designed for children with mild CP. Training sessions will be conducted live via a secure smartphone-based streaming platform three times per week, with each session lasting approximately 40 minutes. Each session includes a 5-minute warm-up, 30 minutes of structured exercises, and a 5-minute cool-down period. Sessions are scheduled in the evening hours (around 7:00-8:00 PM) to accommodate children's school schedules and ensure caregiver availability during home-based participation. Receives: Behavioral: Telehealth-Supervised Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-minute walk test
Participants will be instructed to walk as far as possible without running within one minute, and the total distance covered will be recorded.
Measured: Baseline (week 0) and post-intervention (week 12)
10-meter walk test
Participants will be asked to walk as fast as possible for 10 meters. The test will be performed under two conditions - self-selected and fast walking speeds - with the average of three trials recorded per condition.
Measured: Baseline (week 0) and post-intervention (week 12)
Lower-limb muscle strength
Lower-limb muscle strength will be assessed using the 30-second sit-to-stand test (30s STS), a simple, reliable functional test in which children are instructed to complete as many full STS repetitions as possible from a standard chair within 30 seconds (Romin et al., 2024).
Measured: Baseline (week 0) and post-intervention (week 12)
Balance
Balance will be measured using the Pediatric Balance Scale, a 14-item assessment adapted from the Berg Balance Scale that evaluates functional postural control and is validated for ambulatory children with CP (Her et al., 2012). Tasks include standing on one foot, turning in place, and reaching forward
Measured: Baseline (week 0) and post-intervention (week 12)
Pediatric Quality of Life Inventory
To assess life satisfaction and psychosocial well-being, children and their caregivers will complete the Pediatric Quality of Life Inventory™ (PedsQL) - Cerebral Palsy Module (Varni et al., 2006). This validated instrument measures multiple domains, including physical functioning, emotional well-being, and social participation. Both self-report and parent-proxy formats will be utilized for children aged 5-18 years.
Measured: Baseline (week 0) and post-intervention (week 12)
Secondary outcomes (1)
cost-acceptability survey
Caregivers will complete a cost-acceptability survey designed to assess the perceived affordability and feasibility of the telehealth-delivered training model. The survey will include statements such as "The program is affordable for my family," "10 CNY per session is a fair price for the quality of the program," and "I would continue the training even if not reimbursed," rated on a 5-point Likert scale from strongly agree to strongly disagree. Caregivers will also answer an open-ended question: "What is the maximum price you would be willing to pay per session?" These items aim to evaluate the scalability and economic sustainability of this intervention from the perspective of end users.
Measured: Post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Why it stopped: The study was terminiated due to funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as a single-arm interventional trial to evaluate the feasibility and efficacy of telehealth-supervised resistance training in children with mild CP. From an ethical standpoint, the use of a single-arm design is justified by the well-established benefits of resistance training for improving muscle morphology in this population. Prior RCT have also consistently shown that resistance training produces moderate to large improvements in functional capacity and mobility. Given this body of evidence, withholding treatment or assigning children to a non-intervention control group may present ethical concerns, particularly when a safe, home-based alternative is possibly available. Therefore, a single-arm design is both ethically sound and methodologically appropriate for addressing the research question.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai University of Sport
- Responsible party
- Principal investigator, Yang Zhang, Hunan Normal University
- Investigators
- Bo Zhou, PhD, Study director, Hunan Normal University, College of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061275
- Sponsor's protocol ID
- HunanNU-2025-506
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD protocol was not submitted in the approved institutional review board protocol.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-Supervised Resistance Training to Improve Functional Capacity and Muscle Strength in Children With Cerebral Palsy: Protocol for a Single-Arm Intervention Study
- ClinicalTrials.gov ID
- NCT07061275
- Acronym / sponsor ID
- HunanNU-2025-506
- Conditions
- Cerebral Palsy
- Keywords
- balance, cost, exercise training, gait, group exercise, rehabilitation, strength training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminiated due to funding.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Collaborators
- Shanghai University of Sport
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 11 Jul 2025 (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.
The goal of this clinical trial is to evaluate the feasibility and potential benefits of telehealth-supervised resistance training in ambulatory children aged 6 to 15 years with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I-III.
The main questions it aims to answer are:
- Is a 12-week telehealth-delivered resistance training program feasible and acceptable for children with CP and their caregivers?
- Can the program improve physical function and psychosocial well-being in this population?
Participants will:
- Take part in three 40-minute, live-streamed resistance training sessions each week for 12 weeks, using elastic bands, sandbag weights, and balance tools
- Complete physical assessments before and after the program, including the 1-minute walk test, 10-meter walk test, 30-second sit-to-stand test, and Pediatric Balance Scale
- Complete quality of life surveys using the Pediatric Quality of Life Inventory (PedsQL™ 3.0 CP Module)
- Have caregivers complete a custom questionnaire about the cost and acceptability of the program
Detailed description
Cerebral palsy (CP) is a lifelong neurodevelopmental disorder caused by non-progressive disturbances in the developing fetal or infant brain. It is characterized by impairments in movement and posture, often accompanied by disturbances in sensation, perception, cognition, communication, and behavior. Globally, CP affects an estimated 17 million individuals, with a birth prevalence of approximately 2 to 2.5 per 1,000 live births . In China, more than 6 million children are estimated to be living with CP, and approximately 40,000 new cases occur each year.
Motor impairments in CP often lead to compromised gross motor function, altered gait mechanics, and reduced muscle force generation. These deficits significantly impact daily living activities, including walking, stair climbing, and performing transitions such as standing from a seated position. Muscle weakness, in particular, is a primary contributor to poor mobility and reduced participation in community and educational settings. Children with Gross Motor Function Classification System (GMFCS) levels I-III are ambulatory but may still experience fatigue, slow gait speed, or difficulty in navigating uneven terrain. Resistance training has gained empirical support as an effective intervention for improving muscle strength, joint stability, and gross motor function in children with mild CP. As highlighted in our recent meta-analysis, a growing body of evidence from randomized controlled trials indicates that well-structured, progressive resistance training programs lead to measurable improvements in lower-limb muscle morphology, which is directly related to strength, walking performance, and motor control. Ultimately, these muscle adaptations are closely linked to gains in functional independence, including stair climbing, transitions, and longer walking endurance - activities essential for participation in home, school, and recreational settings.
Despite its proven efficacy, access to therapist-supervised or facility-based resistance training remains limited for many families - particularly those living in low-resource or rural settings. Children with CP are disproportionately represented among lower-income households, and socioeconomic factors can severely limit access to regular rehabilitation services. Out-of-pocket expenses for transportation, time off work for caregivers, and session fees create significant burdens, contributing to inadequate adherence and suboptimal rehabilitation outcomes.
Telehealth has emerged as a promising strategy to overcome these barriers by delivering structured, therapist-guided interventions remotely. The expansion of digital health technologies, particularly during the COVID-19 pandemic, has accelerated the adoption of tele-rehabilitation for various clinical populations. Live-streamed and app-based exercise training programs have shown promise in able-bodied populations due to their low cost, flexibility, and minimal infrastructure requirements. For children with CP, a telehealth model may increase access and engagement while reducing logistical and financial strain on families.
To our knowledge, no published studies have systematically evaluated the effects of telehealth-supervised resistance training specifically targeting improvements in functional capacity among children with CP. Given the affordability of this model - tele-exercise classes may cost as little as 10 CNY per session, and home exercise kits can be assembled using low-cost elastic bands and resistance tools - this approach may provide a viable, family-centered solution. The model is particularly attractive in the context of China and other low- and middle-income countries, where rehabilitation access is highly variable and often concentrated in urban centers.
The present study aims to evaluate the feasibility and efficacy of a telehealth-supervised resistance training program targeting lower-limb muscle strength and functional capacity in children with mild CP. This single-arm intervention trial will examine changes in gross motor ability, lower-limb muscle function, and parent-reported outcomes following a 3-month remotely supervised exercise protocol. The findings will provide initial evidence to inform the scalability and cost-effectiveness of telehealth-based rehabilitation models and may offer an inclusive and sustainable approach for pediatric rehabilitation in socioeconomically disadvantaged settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as a single-arm interventional trial to evaluate the feasibility and efficacy of telehealth-supervised resistance training in children with mild CP. From an ethical standpoint, the use of a single-arm design is justified by the well-established benefits of resistance training for improving muscle morphology in this population. Prior RCT have also consistently shown that resistance training produces moderate to large improvements in functional capacity and mobility. Given this body of evidence, withholding treatment or assigning children to a non-intervention control group may present ethical concerns, particularly when a safe, home-based alternative is possibly available. Therefore, a single-arm design is both ethically sound and methodologically appropriate for addressing the research question.
| Arm | Type | Receives |
|---|---|---|
| Telehealth-Supervised Resistance Training | Experimental | Behavioral: Telehealth-Supervised Resistance TrainingThe intervention consists of a 12-week telehealth-supervised resistance training program designed for children with mild CP. Training sessions will be conducted live via a secure smartphone-based streaming platform three times per week, with each session lasting approximately 40 minutes. Each session includes a 5-minute warm-up, 30 minutes of structured exercises, and a 5-minute cool-down period. Sessions are scheduled in the evening hours (around 7:00-8:00 PM) to accommodate children's school schedules and ensure caregiver availability during home-based participation. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- No history of heart disease or family history of heart disease;
- Children classified as GMFCS levels I, II, or III;
- Dependent on assistive mobility devices, such as wheelchairs or posture support walkers, for activities of daily living;
- Medically stable and able to sit upright for at least 30 minutes;
- Able to understand simple verbal or visual instructions.
Key exclusion criteria (4 listed)
- Aged under 6 years or over 15 years;
- Received botulinum toxin A injections for lower limb muscles within six months prior to baseline assessment;
- Implanted with an intrathecal baclofen pump, or has a history of lower limb-related orthopedic or neurosurgical interventions (such as tendon lengthening, osteotomy, or selective dorsal rhizotomy);
- Has uncontrolled epilepsy, severe cognitive impairment, or other comorbidities.
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 |
|---|---|---|
| Telehealth-Supervised Resistance TrainingThe exercise protocol will incorporate a variety of exercise modalities adapted for home use in limited space environments. Elastic resistance bands will be used for lower-limb strength exercises such as leg presses, hip abduction, and ankle dorsiflexion, while sandbag-style leg weights will be employed for activities including knee extensions, seated marches, and standing squats. To target balance, low-cost tools such as foam pads, balance cushions, or step platforms will be used for tasks including static standing, single-leg stance, and step-up exercises designed to challenge postural control in a safe, progressive manner. Sessions will be delivered through a secure live-streaming platform accessible on smartphones. The streaming platform supports background audio, allowing exercise sessions to be accompanied by music, which may help increase motivation and enjoyment for participating children. Each session will be led by trained instructors from the Hunan Normal University. | Behavioural | Telehealth-Supervised Resistance Training |
Primary outcome
1-minute walk test
Time frame: Baseline (week 0) and post-intervention (week 12)
Participants will be instructed to walk as far as possible without running within one minute, and the total distance covered will be recorded.
10-meter walk test
Time frame: Baseline (week 0) and post-intervention (week 12)
Participants will be asked to walk as fast as possible for 10 meters. The test will be performed under two conditions - self-selected and fast walking speeds - with the average of three trials recorded per condition.
Lower-limb muscle strength
Time frame: Baseline (week 0) and post-intervention (week 12)
Lower-limb muscle strength will be assessed using the 30-second sit-to-stand test (30s STS), a simple, reliable functional test in which children are instructed to complete as many full STS repetitions as possible from a standard chair within 30 seconds (Romin et al., 2024).
Balance
Time frame: Baseline (week 0) and post-intervention (week 12)
Balance will be measured using the Pediatric Balance Scale, a 14-item assessment adapted from the Berg Balance Scale that evaluates functional postural control and is validated for ambulatory children with CP (Her et al., 2012). Tasks include standing on one foot, turning in place, and reaching forward
Pediatric Quality of Life Inventory
Time frame: Baseline (week 0) and post-intervention (week 12)
To assess life satisfaction and psychosocial well-being, children and their caregivers will complete the Pediatric Quality of Life Inventory™ (PedsQL) - Cerebral Palsy Module (Varni et al., 2006). This validated instrument measures multiple domains, including physical functioning, emotional well-being, and social participation. Both self-report and parent-proxy formats will be utilized for children aged 5-18 years.
1 secondary outcome
cost-acceptability survey
Time frame: Post-intervention (week 12)
Results and safety
The study was stopped early (reason given: The study was terminiated due to funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. IPD protocol was not submitted in the approved institutional review board protocol.
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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.
Bo Zhou, PhD study director
Hunan Normal University, College of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-Supervised Resistance Training in people with Cerebral Palsy, run by Hunan Normal University 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 4 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: stopped early, as of the sponsor's last update on 22 Jun 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 was stopped early (reason given: The study was terminiated due to funding.). Results are not available in the source record.
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?
1-minute walk test (time frame: Baseline (week 0) and post-intervention (week 12)). The study lists 5 primary outcomes in all. 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 22 Jun 2026.