Effects of Dynamic Compression Garments in Children With CP

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05592236

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Dynamic compression garments Other: Standard therapy	N/A

Detailed Description

Cerebral palsy (CP) is a group of permanent neurodevelopmental disorders in the development of movement and posture, non-progressive, resulting in activity limitations, resulting from an injury to the developing brain. Children with CP who have problems in sensorimotor coordination due to decreased muscle strength and impaired sensory processing experience postural control problems. In hemiparetic CP, deterioration in the upper extremities affects children's daily living activities such as eating, dressing, undressing, combing hair, brushing teeth, self-care skills, functional independence, and quality of life. Since the trunk plays a very important role in postural control and extremity functions, providing trunk stability and thus effective use of the extremities is one of the important goals of physiotherapy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Dynamic Compression Garments on Posture, Trunk Control and Upper Extremity Functions in Children With Hemiparetic CP

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group 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 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: Standard therapy Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks
Active Comparator: Control Group Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks	Other: Standard therapy Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks

Arm

Intervention/Treatment

Experimental: Study group

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

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: Standard therapy

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

Active Comparator: Control Group

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

Other: Standard therapy

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

Outcome Measures

Primary Outcome Measures

Manual Ability Classification System [8 weeks]
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.
Sitting Assessment Scale [8 weeks]
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.
The Trunk Control Measurement Scale [8 weeks]
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.
Quality of Upper Extremity Skills Test [8 weeks]
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.
ABILHAND-Kids: a measure of manual ability [8 weeks]
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.
Shriners Hospital Upper Extremity Evaluation [8 weeks]
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.
The Pediatric Evaluation of Disability Inventory [8 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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