Back to resultsEffects of Dynamic Compression Garments in Children With CP
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic compression garments
Standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, dynamic compression, postural control, trunk control, upper extremity function
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control Group
Arm Description
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
Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05592236
First Posted
October 20, 2022
Last Updated
March 20, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05592236
Brief Title
Effects of Dynamic Compression Garments in Children With CP
Official Title
Effects of Dynamic Compression Garments on Posture, Trunk Control and Upper Extremity Functions in Children With Hemiparetic CP
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, dynamic compression, postural control, trunk control, upper extremity function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks
Intervention Type
Other
Intervention Name(s)
Dynamic compression garments
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks
Primary Outcome Measure Information:
Title
Manual Ability Classification System
Description
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.
Time Frame
8 weeks
Title
Sitting Assessment Scale
Description
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.
Time Frame
8 weeks
Title
The Trunk Control Measurement Scale
Description
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.
Time Frame
8 weeks
Title
Quality of Upper Extremity Skills Test
Description
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.
Time Frame
8 weeks
Title
ABILHAND-Kids: a measure of manual ability
Description
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.
Time Frame
8 weeks
Title
Shriners Hospital Upper Extremity Evaluation
Description
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.
Time Frame
8 weeks
Title
The Pediatric Evaluation of Disability Inventory
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effects of Dynamic Compression Garments in Children With CP
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