Effect of Pully System on Hemiplegic Children
ConditionCerebral Palsy, Spastic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorKafrelsheikh University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- pulley system exercise regimen
- physical therapy program for CP
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov