Effect of Pully System on Hemiplegic Children

NCT06434246 | Not Yet Recruiting

• 1 other identifier: KFSIRB200--194
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy, Spastic

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months

• 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

  3 months

• 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.

  3 months

• 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

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP.

Behavioral: pulley system exercise regimen; Biological: physical therapy program for CP

Control Group

ACTIVE COMPARATOR

Children will receive designed physical therapy program for CP only

Biological: physical therapy program for CP

Interventions

pulley system exercise regimen BEHAVIORAL

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.

Intervention Group

physical therapy program for CP BIOLOGICAL

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of physical therapy, Kafrelsheik university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed salim, PHD

  Department of pediatric physical therapy and its surgery, Elsalam University

  STUDY DIRECTOR

• Sara Elsebahy, PHD

  Paediatric physical therapy department, Kafrelsheik University

  STUDY DIRECTOR

• Ahmed Ali M Torad, PHD

  Basic science department, kafrelsheik university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Ali M Torad, PHD

CONTACT

01008889975; ahmed.ali.torad@gmail.com

Sara Elsebahy, PHD

CONTACT

01094998882; Drsaraelsabahy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: February 20, 2025
• Primary Completion: August 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 6 months after the publication of the study results. The data will be accessible for a period of 5 years.
• Access Criteria: Researchers who wish to access the data must submit a formal request to the principal investigator. The request should include a research proposal outlining the purpose of the data use, the intended analysis, and the potential benefits of the research. Requests will be reviewed based on scientific merit and ethical considerations.

Locations

EG (1)