Telehealth-Supervised Resistance Training for Children With Cerebral Palsy

NCT07061275 | Not Yet Recruiting

• 1 other identifier: HunanNU-2025-506
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Cerebral Palsy

Keywords

balance; cost; exercise training; gait; group exercise; rehabilitation; strength training

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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).

  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

  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.

  Baseline (week 0) and post-intervention (week 12)

Secondary Outcomes (1)

• cost-acceptability survey

  Post-intervention (week 12)

Study Arms (1)

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.

Behavioral: Telehealth-Supervised Resistance Training

Interventions

Telehealth-Supervised Resistance Training BEHAVIORAL

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.

Telehealth-Supervised Resistance Training

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Normal University: lead
• Shanghai University of Sport: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Bo Zhou, PhD

  Hunan Normal University, College of Physical Education

  STUDY DIRECTOR

Central Study Contacts

Yang Zhang, PhD

CONTACT

7272559368; yzhang68@crimson.ua.edu

Dinghua Liu, MS

CONTACT

8618807486231; ldh1034404826@hunnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle scientist

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 11, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share