Cerebral Palsy, SpasticNCT05682079
The Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Cerebral Palsi
An observational study of Cerebral Palsy, Spastic, run by Nursena Güçlü at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 15 Nov 2022
- How long will I take part?
- 14 Days
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals aged 6-18 years
Who may be able to join
- Being between 6-18 years old,
- Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy,
- No communication problem,
- GMFCS level was determined to be between I-III.
Who cannot join
- The parent who will answer the form does not know Turkish,
- Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study,
- It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Spastic Cerebral Palsy.
Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.
Read the detailed description
Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.
23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity
- Keywords
- Trunk Control, Respiratory Muscle Strength, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCMS, PEDİ, respiration, GMFCS,PBS,functional capacityOther
The Trunk Control Measurement Scale evaluates the two main components of trunk control, static sitting balance and dynamic sitting balance. The scale includes a total of 15 items. The Pediatric Disability Assessment Inventory evaluates ADLs in individuals between the ages of 6 months and 7.5 years. It is a detailed clinical assessment scale that evaluates the functional skills and performance of individuals. Items in this section are scored as "0=cannot" and "1=can". The Pediatric Berg Balance Scale is an adapted version of the Berg Balance test for adults, which consists of 14 questions. It is a scale that consists of 14 questions and evaluates balance functionally. For the 2-minute walking test; They were asked to walk at their own pace without running for 2 minutes on a quiet, concrete walkway 15 m long. It was repeated 2 times with a 10-minute rest between each trial. Respiratory muscle strength was measured using a portable, electronic mouth pressure measuring device.
| Study group | Role | What they receive |
|---|---|---|
| children with cerebral palsy | After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Receives: Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity | |
| typical kids | After recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Receives: Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System (GMFCS)
Level I: Walks without restraint. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is restricted. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start15 Aug 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Nursena Güçlü
- Sponsor type
- University, hospital or other
- Collaborators
- yeni kurtuluş özel eğitim ve rehabilitasyon merkezi, Özel Gelişim Akademi Özel Eğitim ve Rehabilitasyon Merkezi
- Responsible party
- Sponsor-investigator, Nursena Güçlü, Kırıkkale University
- Investigators
- saniye aydoğan arslan, Study director, kırıkkale üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682079
- Sponsor's protocol ID
- KirikkaleUni2
- Status last verified
- Aug 2023
- First submitted
- 23 Dec 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guclu Sayin NS, Aydogan Arslan S, Korkem Yorulmaz D. Examination of the relationship between respiratory muscle strength, postural control, functional exercise capacity, and daily living activities in individuals with spastic cerebral palsy: A case-control study. Dev Neurorehabil. 2026 Jan-Feb;29(1-2):10-17. doi: 10.1080/17518423.2026.2665088. Epub 2026 Apr 29.
PubMed 42057323
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Functional Exercise Capacity, Respiratory Muscle Strength, Trunk Control, Balance and Activities of Daily Living in Individuals With Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05682079
- Acronym / sponsor ID
- KirikkaleUni2
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Trunk Control, Respiratory Muscle Strength, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nursena GüçlüUniversity, hospital or other
- Collaborators
- yeni kurtuluş özel eğitim ve rehabilitasyon merkezi, Özel Gelişim Akademi Özel Eğitim ve Rehabilitasyon Merkezi
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 12 Jan 2023 (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.
Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.
Detailed description
Cerebral palsy (CP) causes problems in posture, movement, breathing, postural control and balance in individuals. This work; This study was conducted to examine the relationship between functional exercise capacity, respiratory muscle strength, trunk control, balance and activities of daily living in individuals with spastic cerebral palsy.
23 children with spastic type CP and 22 typically developing children aged 6-18 years were included in the study. After recording the demographic data, the trunk control "Trunk control measurement scale" (TCMS), the activities of daily living "Pediatric Disability Assessment Inventory" (PDI), the balance "Pediatric Berg Balance Scale" (PBDI), functional exercise capacity "2 Minute Walking Test" and respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. Compared to individuals with typical development, individuals with CP had lower TCMS, PPI, PBRS, 2-minute walking test and respiratory muscle strength values (p<0.01). At the same time, it was observed that individuals with hemiparetic CP had better TCMS, PPI, PBRS scores, functional exercise capacities and respiratory muscle strength compared to individuals with diparetic disease and individuals with CP at GMFCS I level compared to individuals with other levels. It was found that there was a high correlation between trunk control, balance and functional capacity of individuals with CP. It was concluded that the influence on trunk control affects balance and functional capacity. There was also a correlation between the scales.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with cerebral palsy | – | Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacityAfter recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. |
| typical kids | – | Other: TCMS, PEDİ, respiration, GMFCS,PBS,functional capacityAfter recording demographic data, "Trunk control measurement scale" (TCMS) to evaluate trunk control, "Gorge motor function classification system" (GMFCS) to measure gross motor functions, "Pediatric Disability Assessment Inventory" (PDI) to evaluate activities of daily living, balance 'Pediatric Berg Balance Scale' was used to evaluate functional capacities and '2-minute walking test' was used to evaluate functional capacities. In addition, respiratory muscle strength was evaluated with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals aged 6-18 years
Key inclusion criteria (4 listed)
- Being between 6-18 years old,
- Having been diagnosed with spastic hemiplegic or spastic diplegic cerebral palsy,
- No communication problem,
- GMFCS level was determined to be between I-III.
Key exclusion criteria (3 listed)
- The parent who will answer the form does not know Turkish,
- Orthopedic surgical treatment and botulinum toxin injection in the 6 months before the study,
- It was determined as having other orthopedic, neurological and cardiopulmonary diseases that may affect balance and gait.
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 |
|---|---|---|
| TCMS, PEDİ, respiration, GMFCS,PBS,functional capacityThe Trunk Control Measurement Scale evaluates the two main components of trunk control, static sitting balance and dynamic sitting balance. The scale includes a total of 15 items. The Pediatric Disability Assessment Inventory evaluates ADLs in individuals between the ages of 6 months and 7.5 years. It is a detailed clinical assessment scale that evaluates the functional skills and performance of individuals. Items in this section are scored as "0=cannot" and "1=can". The Pediatric Berg Balance Scale is an adapted version of the Berg Balance test for adults, which consists of 14 questions. It is a scale that consists of 14 questions and evaluates balance functionally. For the 2-minute walking test; They were asked to walk at their own pace without running for 2 minutes on a quiet, concrete walkway 15 m long. It was repeated 2 times with a 10-minute rest between each trial. Respiratory muscle strength was measured using a portable, electronic mouth pressure measuring device. | Other | children with cerebral palsy, typical kids |
Primary outcome
Gross Motor Function Classification System (GMFCS)
Time frame: 2 week
Level I: Walks without restraint. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is restricted. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair.
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 1 Sep 2023.
- Derived from this study: PubMed 42057323Guclu Sayin NS, Aydogan Arslan S, Korkem Yorulmaz D. Examination of the relationship between respiratory muscle strength, postural control, functional exercise capacity, and daily living activities in individuals with spastic cerebral palsy: A case-control study. Dev Neurorehabil. 2026 Jan-Feb;29(1-2):10-17. doi: 10.1080/17518423.2026.2665088. Epub 2026 Apr 29.
- 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.
saniye aydoğan arslan study director
kırıkkale üniversitesi
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, Spastic, run by Nursena Güçlü 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 4 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 1 Sep 2023. 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?
Gross Motor Function Classification System (GMFCS) (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682079, which also lists 1 linked publication.
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 1 Sep 2023.