Not Yet RecruitingNot Applicable

Effect of Pully System on Hemiplegic Children

Egypt32 participantsStarted 2025-02-20

Plain-language summary

Introduction Cerebral palsy (CP) is a group of sensory, motor, and postural disorders caused by non-progressive brain injury in early development. It can manifest in various forms, including hemiplegia, which affects about 21% to 40% of CP cases. Upper extremity (UE) impairments in CP individuals are significant, impacting daily activities and quality of life. Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP. Methods Design: Randomized controlled double-blinded trial. Participants: 32 children aged 3-7 years with hemiplegic CP, divided into intervention and control groups. Intervention: The intervention group receives pulley system exercises plus standard care, while the control group receives standard physical therapy. Duration: Conducted between June 2024 and August 2024. Inclusion Criteria: Diagnosed with hemiplegic CP, aged 3-7 years, able to follow instructions, and with upper limb motor deficits. Exclusion Criteria: Additional neurological disorders, recent upper limb surgery, previous rehabilitation programs, severe medical conditions, or contraindications to physical activity. Assessment Tools: Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and Lafayette Manual Muscle Tester. Timing: Baseline and after 3 months of intervention. Treatment Intervention Group: 45-60 minute sessions, three times a week, involving warm-up, pulley system exercises, and cool-down. Control Group: Standard care physical therapy, twice a week, 45-60 minute sessions. Statistical Analysis Methods: Descriptive statistics and Analysis of Covariance (ANCOVA) to analyze improvements in upper limb function. Significance Level: p \< 0.05. Analysis: Intention-to-treat to handle missing data. This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP, potentially improving their independence and quality of life.

Who can participate

Age range

3 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens.
. Recent surgery (within the last 6 months) on the upper limbs.
. Children who have been involved in similar rehabilitation programs in the past 3 months.
. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assisting Hand Assessment (AHA)

Timeframe: 3 months

The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function

Timeframe: 3 months

Quality Upper Extremity Skills Test (QUEST)

Timeframe: 3 months

Lafayette Manual Muscle Tester

Timeframe: 3 months

Trial details

NCT IDNCT06434246

SponsorKafrelsheikh University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-20

Contact for this trial

Ahmed Ali M Torad, PHD

01008889975 ahmed.ali.torad@gmail.com

View on ClinicalTrials.gov More Cerebral Palsy, Spastic trials

Plain-language summary

Who can participate

Age range

3 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens.
. Recent surgery (within the last 6 months) on the upper limbs.
. Children who have been involved in similar rehabilitation programs in the past 3 months.
. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional.