Cerebral PalsyNCT05592236
Effects of Dynamic Compression Garments in Children With CP
A study testing Dynamic compression garments and Standard therapy in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Dynamic compression garments and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effects of Dynamic Compression Garments on Posture, Trunk Control and Upper Extremity Functions in Children With Hemiparetic CP
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Dynamic compression garments, Standard therapy
- Keywords
- cerebral palsy, dynamic compression, postural control, trunk control, upper extremity function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic compression garmentsOther
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 therapyOther
Standard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start15 Jun 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592236
- Sponsor's protocol ID
- 004
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Compression Garments on Posture, Trunk Control and Upper Extremity Functions in Children With Hemiparetic CP
- ClinicalTrials.gov ID
- NCT05592236
- Acronym / sponsor ID
- 004
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, dynamic compression, postural control, trunk control, upper extremity function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Dynamic compression garments, Other: Standard therapyDynamic 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 |
| Control Group | Active comparator | Other: Standard therapyStandard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic compression garmentsDynamic 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 | Study group |
| Standard therapyStandard therapy twice a week (1 session of 45 minutes) for a total of 6 weeks | Other | Control Group, Study group |
Primary outcome
Manual Ability Classification System
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic compression garments and Standard therapy in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Ability Classification System (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.