Clinical trial
Effect of Pully System Exercise on Upper Limb Function in Hemiplegic Cerebral Palsy Children: A Randomized Clinical Trials
Name
KFSIRB200-193
Description
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.
Trial arms
Trial start
2024-11-20
Estimated PCD
2025-08-20
Trial end
2025-11-20
Status
Not yet recruiting
Treatment
pulley system exercise regimen
The warm-up consists of gentle stretching and basic mobility exercises to prepare the muscles and joints for the activity. Following this, the main segment of the session involves specific exercises using the pulley system, designed to target and improve motor function, strength, and coordination of the upper limbs. The therapist will adjust the exercises according to each child's individual abilities and progression over time. The session concludes with a cool-down period involving light activities and relaxation techniques to ensure a gradual return to baseline physiological states.
Arms:
Intervention Group
physical therapy program for CP
Participants in the control group will attend physical therapy sessions twice per week. These sessions aim to maintain or improve physical functioning and manage the symptoms of cerebral palsy. Each session lasts approximately 45 to 60 minutes, These sessions include a variety of therapeutic exercises tailored to each child's needs but do not include the use of the pulley system. Typical activities might involve stretching, strengthening exercises, and manual therapy techniques to enhance joint mobility and muscle function.
Arms:
Control Group, Intervention Group
Size
32
Primary endpoint
Assisting Hand Assessment (AHA)
3 months
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function
3 months
Quality Upper Extremity Skills Test (QUEST)
3 months
Lafayette Manual Muscle Tester
3 months
Eligibility criteria
Inclusion Criteria
* Children aged between 3 and 7 years.
* Diagnosed with hemiplegic cerebral palsy, confirmed by a pediatric neurologist.
* Ability to follow simple instructions and participate in exercise sessions.
* Presence of upper limb motor function deficits attributable to hemiplegic cerebral palsy.
Exclusion Criteria
1. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens.
2. Recent surgery (within the last 6 months) on the upper limbs.
3. Children who have been involved in similar rehabilitation programs in the past 3 months.
4. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}
Updated at
2024-05-30
1 organization
Organization
Kafrelsheikh University