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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
pulley system exercise regimen
BehavioralThe 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.
physical therapy program for CP
Biological/VaccineParticipants 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Assisting Hand Assessment (AHA)
will be used to evaluate how effectively children with upper limb impairments can use their affected hand together with their well-functioning hand to perform bimanual tasks. This assessment involves observing the child while they engage in play activities that require bimanual coordination. The performance is video-recorded and scored based on specific criteria that assess the spontaneous use of the involved hand. The scoring system provides a measure of the child's ability to effectively use their affected hand in bimanual tasks, with higher scores indicating better function.
Time frame
3 months2
The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function
will be conducted to measures fine and gross motor skills, including hand function. Specific subtests related to hand function are administered, such as fine motor precision, fine motor integration, and manual dexterity tasks. Performance on these tasks is quantitatively scored, allowing for the assessment of motor proficiency and hand function improvements
Time frame
3 months3
Quality Upper Extremity Skills Test (QUEST)
will be used to assess movement patterns and hand function in children with cerebral palsy. It evaluates dissociated movements, grasp patterns, protective extension, and weight bearing under four domains: dissociated movements, grasp, weight bearing, and protective extension. Each item is scored based on the child's ability to perform the task, with scores reflecting the quality of upper extremity skills.
Time frame
3 months4
Lafayette Manual Muscle Tester
will be used to objectively measure the strength of specific muscles and muscle groups. The muscle tester is applied to the muscle group being evaluated while the child performs a muscle contraction. The device provides a digital readout of the force exerted, which can be measured in pounds or kilograms. In this study, the tester will be used to evaluate the strength of upper limb muscles before and after the intervention to assess any changes due to the pulley system exercises
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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