Cerebral PalsyNCT05206461
Relationship Between Trunk Control and Hand Function and Quality of Life
An observational study of Cerebral Palsy and Quality of Life, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Quality of Life, Hand
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 13 Dec 2021
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with hemiparetic and diparetic Cerebral Palsy aged 5-18
Who may be able to join
- Being between the ages of 5-18,
- Having a diagnosis of hemiparetic or diparetic CP,
- To be at the level of I-II-III according to the Gross Motor Function Classification System,
- Not having had orthopedic surgery on the upper extremity in the last 6 months,
- Not having been injected with Botulinum Toxin-A in the last 6 months,
- Accepting the study and signing the consent form.
Who cannot join
- Children who could not understand and follow simple verbal commands,
- Did not meet the inclusion criteria,
- Incomplete assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Trunk Control Which is Fundamental in Hemiparetic and Diparetic Cerebral Palsied Children: Its Relationship With Hand Function and Quality of Life
Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy.
Read the detailed description
Trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory. Participants were informed about the procedure of the tests. The evaluation period lasted 30-40 minutes for each child.
- Conditions
- Cerebral Palsy, Quality of Life, Hand
- Being tested
- Trunk Control Measurement Scale
- Keywords
- Cerebral Palsy, Trunk Control, Hand Function, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk Control Measurement ScaleOther
Also called 9-Hole Peg Test, Pediatric Quality of Life Inventory
Trunk Control Measurement Scale, easy and simple to use, was used to evaluate trunk control
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic CP | Trunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Hemiparetic CP Receives: Other: Trunk Control Measurement Scale | |
| Diparetic CP | Trunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Diparetic CP Receives: Other: Trunk Control Measurement Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Control Measurement Test
Trunk control
Measured: Baseline
9-Hole Peg Test
Hand function
Measured: Baseline
Pediatric Quality of Life Inventory
Quality of life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jan 2020
- Primary completion1 Sep 2021
- Study completion13 Dec 2021
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feride Yarar, Asst Prof,PT, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206461
- Sponsor's protocol ID
- KaratayU1
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 25 Jan 2022
- 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trunk Control Which is Fundamental in Hemiparetic and Diparetic Cerebral Palsied Children: Its Relationship With Hand Function and Quality of Life
- ClinicalTrials.gov ID
- NCT05206461
- Acronym / sponsor ID
- KaratayU1
- Conditions
- Cerebral Palsy, Quality of Life, Hand
- Keywords
- Cerebral Palsy, Trunk Control, Hand Function, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 25 Jan 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.
Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy.
Detailed description
Trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory. Participants were informed about the procedure of the tests. The evaluation period lasted 30-40 minutes for each child.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic CP | – | Other: Trunk Control Measurement ScaleTrunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Hemiparetic CP |
| Diparetic CP | – | Other: Trunk Control Measurement ScaleTrunk control, hand function and quality of life were evaluated with the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory in Diparetic CP |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with hemiparetic and diparetic Cerebral Palsy aged 5-18
Key inclusion criteria (6 listed)
- Being between the ages of 5-18,
- Having a diagnosis of hemiparetic or diparetic CP,
- To be at the level of I-II-III according to the Gross Motor Function Classification System,
- Not having had orthopedic surgery on the upper extremity in the last 6 months,
- Not having been injected with Botulinum Toxin-A in the last 6 months,
Key exclusion criteria (3 listed)
- Children who could not understand and follow simple verbal commands,
- Did not meet the inclusion criteria,
- Incomplete assessments.
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 |
|---|---|---|
| Trunk Control Measurement ScaleAlso: 9-Hole Peg Test, Pediatric Quality of Life InventoryTrunk Control Measurement Scale, easy and simple to use, was used to evaluate trunk control | Other | Diparetic CP, Hemiparetic CP |
Primary outcome
Trunk Control Measurement Test
Time frame: Baseline
Trunk control
9-Hole Peg Test
Time frame: Baseline
Hand function
Pediatric Quality of Life Inventory
Time frame: Baseline
Quality of life
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 25 Jan 2022.
- 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.
Feride Yarar, Asst Prof,PT study chair
Pamukkale University
1 site 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 and Quality of Life, run by KTO Karatay University at 1 site 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 6 inclusion and 3 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Test (time frame: Baseline). The study lists 3 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 25 Jan 2022.