Cerebral PalsyNCT05158634
Relationship of Trunk Control and Endurance with Balance and Functional Mobility in Cerebral Palsy
An observational study of Cerebral Palsy, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
It is predicted by studies that the motor and cognitive performance disorders seen in children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Evaluations
- How many people
- 32 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 20 Feb 2022
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Being diagnosed with Cerebral Palsy. Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2). Be between the ages of 6-18.
Who may be able to join
- Being diagnosed with Cerebral Palsy Volunteer Be between the ages of 6-18 Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2).
- To have the cognitive skills to understand and apply the evaluation parameters.
Who cannot join
- Participants diagnosed with Cerebral Palsy having cognitive disorders Participants diagnosed with Cerebral Palsy having vision or hearing problems Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Universitesi-Cerrahpasa
Istanbul, Istanbul
Işıl Özel Eğitim ve Rehabilitasyon Merkezi
Istanbul, Istanbul
About this study
Official title: Investigation of the Relationship of Trunk Control and Endurance with Balance and Functional Mobility in Children with Cerebral Palsy
It is predicted by studies that the motor and cognitive performance disorders seen in children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility. At the same time, trunk muscle fatigue seen in children with CP is a critical motor problem and may cause deficits in adjusting the proper connection between the trunk and pelvis stabilizers.These deficits can lead to impairments in balance, postural control and mobility. Considering the relationship between the deficits seen in children with CP and postural control and postural control with the trunk, the idea that there is a need for studies that evaluate the trunk in every way and reveal its relationship with balance, postural control and mobility in order to organize the rehabilitation program effectively in children with CP. Therefore, in the planning of our study, it was aimed to evaluate trunk control and endurance in children with CP and to examine their relationship with balance and functional mobility parameters, as well as to reveal their relationship with functional health and quality of life.
- Conditions
- Cerebral Palsy
- Being tested
- Evaluations
- Keywords
- Cerebral Palsy, Trunk Control, Mobility, Balance, Functional Health, Endurance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationsOther
Within the scope of the study, the participants will be evaluated for 30 minutes in a single session. The participants' trunk stabilization and endurance, balance, functional mobility, upper extremity endurance, functional health and quality of life will be questioned by questionnaires, scales and tests. Evaluation will begin with a literature-supported demographic data form prepared for the participants.
Assessments to be made are listed below. Trunk Control Measurement Scale (TCMS) Pediatric Balance Scale (PBS) Time Up and Go test (TUG) Trunk Flexor Test (TFT) The Pediatric Outcomes Data Collection Instrument (PODCI)
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy | Inclusion Criterias: Being diagnosed with Cerebral Palsy. Volunteer. Be between the ages of 6-18. Being at level 1 and level 2 according to Gross Motor Function Classification System (GMFCS) (Level 1 and 2).
To have the cognitive skills to understand and apply the evaluation parameters.
Exclusion Criterias: Cognitive impairment of participants diagnosed with Cerebral Palsy. Participants diagnosed with Cerebral Palsy have vision or hearing problems. Participants diagnosed with Cerebral Palsy must have a history of trauma such as botox or muscle relaxation operation and/or fracture at least 6 months before participating in the study. Receives: Other: Evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Scale (TCMS)
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Measured: Baseline
Pediatric Balance Scale (PBS)
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Measured: Baseline
Time Up and Go (TUG)
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.
Measured: Baseline
Trunk Endurance
In the test performed to evaluate trunk endurance, the starting position is trunk flexed to 60 degrees (supported by a foam wedge), hips and knees flexed to 90 degrees, and feet in a stable position. In the test position, after the wedge is lifted, the participant is asked to try to keep the body in the flexion position at 60 degrees as much as possible and the time is recorded in seconds. The trunk endurance of the participants will be evaluated with the Trunk Flexor Test.
Measured: Baseline
Secondary outcomes (2)
Modified Push-up Test
In the test used to evaluate the endurance of the upper extremities, in the starting position, individuals are asked to lie in a prone position, take their hands at shoulder level, flex their elbows to the side of the trunk, and bring their knees to 90 degrees of flexion. Then, while in this position, they are asked to raise the head, shoulders and trunk for 30 seconds, with the elbows in full extension. The number of repetitions of the movement for 30 seconds is recorded. Participants' upper extremity endurance will be evaluated with the Modified Push-up Test.
Measured: Baseline
Pediatric Outcomes Data Collection Instrument (PODCI)
PODCI has 2 parent forms (child and adolescent) and adolescent forms consisting of the same questions. The test is a Likert-type scale and consists of 5 parts: Upper Extremity Functions-UEF, Physical Function and Sport-FFS, Transfer and Basic Mobility-TM, Pain-RA and Happiness / Satisfaction-MM, as well as Expectations-TB section where expectations from treatment are questioned. Each section is calculated between 0-100. Participants' quality of life will be evaluated with PODCI.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start30 Dec 2021
- Primary completion28 Jan 2022
- Study completion20 Feb 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asena Yekdaneh, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Asena Yekdaneh, Pt.,MSc., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158634
- Sponsor's protocol ID
- A.Gulnergiz
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2021
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Trunk Control and Endurance with Balance and Functional Mobility in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05158634
- Acronym / sponsor ID
- A.Gulnergiz
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Trunk Control, Mobility, Balance, Functional Health, Endurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 15 Dec 2021 (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.
It is predicted by studies that the motor and cognitive performance disorders seen in children with Cerebral Palsy (CP) may lead to loss of balance, postural control and mobility. At the same time, trunk muscle fatigue seen in children with CP is a critical motor problem and may cause deficits in adjusting the proper connection between the trunk and pelvis stabilizers.These deficits can lead to impairments in balance, postural control and mobility. Considering the relationship between the deficits seen in children with CP and postural control and postural control with the trunk, the idea that there is a need for studies that evaluate the trunk in every way and reveal its relationship with balance, postural control and mobility in order to organize the rehabilitation program effectively in children with CP. Therefore, in the planning of our study, it was aimed to evaluate trunk control and endurance in children with CP and to examine their relationship with balance and functional mobility parameters, as well as to reveal their relationship with functional health and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy | – | Other: EvaluationsInclusion Criterias: Being diagnosed with Cerebral Palsy. Volunteer. Be between the ages of 6-18. Being at level 1 and level 2 according to Gross Motor Function Classification System (GMFCS) (Level 1 and 2). To have the cognitive skills to understand and apply the evaluation parameters. Exclusion Criterias: Cognitive impairment of participants diagnosed with Cerebral Palsy. Participants diagnosed with Cerebral Palsy have vision or hearing problems. Participants diagnosed with Cerebral Palsy must have a history of trauma such as botox or muscle relaxation operation and/or fracture at least 6 months before participating in the study. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Being diagnosed with Cerebral Palsy. Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2). Be between the ages of 6-18.
Key inclusion criteria (2 listed)
- Being diagnosed with Cerebral Palsy Volunteer Be between the ages of 6-18 Being at level 1 and 2 according to Gross Motor Function Classification System (GMFCS) (Level 1-2).
- To have the cognitive skills to understand and apply the evaluation parameters.
Key exclusion criteria (1 listed)
- Participants diagnosed with Cerebral Palsy having cognitive disorders Participants diagnosed with Cerebral Palsy having vision or hearing problems Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
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 |
|---|---|---|
| EvaluationsWithin the scope of the study, the participants will be evaluated for 30 minutes in a single session. The participants' trunk stabilization and endurance, balance, functional mobility, upper extremity endurance, functional health and quality of life will be questioned by questionnaires, scales and tests. Evaluation will begin with a literature-supported demographic data form prepared for the participants. Assessments to be made are listed below. Trunk Control Measurement Scale (TCMS) Pediatric Balance Scale (PBS) Time Up and Go test (TUG) Trunk Flexor Test (TFT) The Pediatric Outcomes Data Collection Instrument (PODCI) | Other | Cerebral Palsy |
Primary outcome
Trunk Control Measurement Scale (TCMS)
Time frame: Baseline
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Pediatric Balance Scale (PBS)
Time frame: Baseline
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Time Up and Go (TUG)
Time frame: Baseline
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.
Trunk Endurance
Time frame: Baseline
In the test performed to evaluate trunk endurance, the starting position is trunk flexed to 60 degrees (supported by a foam wedge), hips and knees flexed to 90 degrees, and feet in a stable position. In the test position, after the wedge is lifted, the participant is asked to try to keep the body in the flexion position at 60 degrees as much as possible and the time is recorded in seconds. The trunk endurance of the participants will be evaluated with the Trunk Flexor Test.
2 secondary outcomes
Modified Push-up Test
Time frame: Baseline
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Ayşe Asena Yekdaneh, Pt.,MSc. principal investigator
Istanbul University - Cerrahpasa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trunk Control Measurement Scale (TCMS) (time frame: Baseline). The study lists 4 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 14 Jan 2025.