Effects of Dynamic Compression Garments in Children With CP

NCT05592236 | Unknown

• 1 other identifier: 004
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

In recent years, it is seen that dynamic compression garments are used to increase body stability and to provide tone regulation. Dynamic compression garments are used to apply pressure to specific muscles or muscle groups. Different studies have drawn attention to the effect of dynamic compression garments on postural control and proximal stability. Researchers observed that upper extremity functions and fine motor skills improved with the use of clothing, and they associated this with improved proximal stability. In light of this information, the aim of this study is; To investigate the effects of dynamic compression garments applied in addition to traditional treatment on posture, trunk control, and upper extremity functions during sitting in children with hemiparetic CP.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; dynamic compression; postural control; trunk control; upper extremity function

Outcome Measures

Primary Outcomes (7)

• Manual Ability Classification System

  Individuals' manual dexterity will be classified according to Manual Ability Classification System before treatment. Manual Ability Classification System is a 5-level classification system developed to classify how children with cerebral palsy aged 4-18 use their hands while holding objects during activities of daily living.

  8 weeks

• Sitting Assessment Scale

  It is a standard video-based observation tool designed for the assessment of sitting in children with cerebra palsy. The scale consists of five items: head control, trunk control, foot control, arm functions and hand functions and is evaluated as follows: 1= none; 2= weak; 3= reasonable; 4 = good. Minimum and maximum scores range from 5 to 20.

  8 weeks

• The Trunk Control Measurement Scale

  The Trunk Control Measurement Scale measures two key components of trunk control during functional activities. For this reason, the scale consists of two parts: Static Sitting Balance and Dynamic Sitting Balance. The scale consists of 15 items in total. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.

  8 weeks

• Quality of Upper Extremity Skills Test

  It is a test that evaluates the quality of movement and manual skills of children with cerebral palsy. It deals with how the child does the activity. It consists of 7 parts. The evaluator scores the test by observing how the child performs the desired movements. The increase in the score obtained from the test indicates the increase in the quality of upper extremity skills.

  8 weeks

• ABILHAND-Kids: a measure of manual ability

  ABILHAND-Kids is a 21-item scale that evaluates bilateral hand use in activities of daily living in children with cerebral palsy. Each sub-item evaluates the difficulty level of children while performing the activity at three levels as impossible, difficult and easy.

  8 weeks

• Shriners Hospital Upper Extremity Evaluation

  It is an upper extremity movement and function assessment tool based on video observation for children aged 3-18 years. It consists of 3 sub-sections: positional dynamic analysis, spontaneous functional analysis and catch-release function.

  8 weeks

• The Pediatric Evaluation of Disability Inventory

  It is a scale used to evaluate changes in performance, functional skills and functional skills in children. It consists of 3 subsections. These; "Functional skills", "Caregiver level of help" and "Adaptations". Each division consists of the areas of self-care, mobility and social function. Functional skills subsection will be used in accordance with the purpose of our study.

  8 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Dynamic compression garments for 2 hours a day in addition to standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks

Other: Dynamic compression garments; Other: Standard therapy

Control Group

ACTIVE COMPARATOR

Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks

Other: Standard therapy

Interventions

Dynamic compression garments OTHER

Dynamic compression garments for 2 hours a day in addition to standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks

Study group

Standard therapy OTHER

Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks

Control Group; Study group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being diagnosed with congenital spastic hemiparetic cerebral palsy,
• To be between the ages of 4-18
• To be at the level of I, II or III according to the Manual Ability Classification System
• Having sufficient communication skills
• The willingness of the family and the child to be included in the study

You may not qualify if:

• The family's refusal to participate in the study
• Botulinum toxin application to the upper extremity or having undergone upper extremity surgery in the last 6 months
• Having behavioral and communication problems that hinder the practices to be carried out within the scope of the study
• Having an epileptic seizure

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

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: Assist. Prof

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: June 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03