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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05592236
Other study ID # 004
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2023
Est. completion date December 15, 2023

Study information

Verified date March 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date December 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: 1. Being diagnosed with congenital spastic hemiparetic cerebral palsy, 2. To be between the ages of 4-18 3. To be at the level of I, II or III according to the Manual Ability Classification System 4. Having sufficient communication skills 5. The willingness of the family and the child to be included in the study Exclusion Criteria: 1. The family's refusal to participate in the study 2. Botulinum toxin application to the upper extremity or having undergone upper extremity surgery in the last 6 months 3. Having behavioral and communication problems that hinder the practices to be carried out within the scope of the study 4. Having an epileptic seizure

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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