Cerebral PalsyNCT07136129
Functional Exercise Performance in Children With Cerebral Palsy: Is the One-Minute Sit-to-Stand Test an Alternative to the Six-Minute Walk Test
An observational study of Cerebral Palsy and Cerebral Palsy Spastic Hemiplegic, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the validity of the 1-minute sit-to-stand test (1MSTS) as a practical and time-efficient alternative to the 6-minute walk test (6MWT) for assessing functional exercise capacity in children with spastic cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy Spastic Hemiplegic
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2024to 1 Jul 2025
- 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: The study population consisted of children aged between 5 and 18 years who were diagnosed with spastic hemiplegic type cerebral palsy (CP) and were being followed up at the Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital between December 2024 and July 2025. These individuals were classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), indicating relatively high levels of functional mobility. All participants and their legal guardians were informed about the study's purpose and procedures, and written informed consent was obtained. The study was approved and conducted in accordance with the principles of the Declaration of Helsinki.
Who may be able to join
- Having spastic hemiplegic CP between 5-18
- Being level 1 and 2 according to KMFSS
Who cannot join
- Having cognitive/mental problems at a level that may prevent communication
- Having genetic and/or neurological problems in addition to CP
- Having uncontrolled heart disease
- Having any infection Removal Criteria
- The child or his/her parents wanting to leave the study
- Failure to complete the tests to be applied within the scope of the study
- Having an additional disease/surgical operation during the study
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the validity of the 1-minute sit-to-stand test (1MSTS) as a practical and time-efficient alternative to the 6-minute walk test (6MWT) for assessing functional exercise capacity in children with spastic cerebral palsy (CP). Children aged 5 to 18 years with spastic hemiplegic CP, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), will perform both tests on the same day. Cardiopulmonary responses and fatigue will be monitored before and after each test. The study aims to determine whether the 1MSTS can be reliably used in clinical settings as a simpler assessment tool for this population.
Read the detailed description
This cross-sectional study was conducted between December 2024 and July 2025 at Kayseri City Hospital with children diagnosed with spastic hemiplegic cerebral palsy, aged 5-18 years, classified as Level I or II on the Gross Motor Function Classification System (GMFCS). Children with severe cognitive impairment, additional neurological disorders, or uncontrolled health conditions were excluded.
Participants completed both the 6-minute walk test (6MWT) and the 1-minute sit-to-stand test (1MSTS) on the same day, in random order. Tests were performed twice, and a 1-hour rest was given between them. Cardiovascular and respiratory parameters (heart rate, oxygen saturation, blood pressure), dyspnea, and leg fatigue were measured before and after each test using standard tools (pulse oximeter, sphygmomanometer, Modified Borg Scale).
The 6MWT followed ATS guidelines. The 1MSTS was performed using a height-adjustable chair without armrests, and participants stood up and sat down repeatedly for one minute. The number of completed repetitions was recorded. This study followed the Declaration of Helsinki, and written informed consent was obtained from all participants and their guardians.
- Conditions
- Cerebral Palsy, Cerebral Palsy Spastic Hemiplegic
- Keywords
- cerebral palsy, One-Minute Sit-to-Stand Test, Functional Exercise Performance in Cerebral Palsy, Six-Minute Walk Test
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spastic hemiplegic type SP | Individuals between 5 and 18 years of age, diagnosed with spastic hemiplegic type CP and in level I or II according to the Gross Motor Function Classification System (GMFCS) were included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Repetitions in the 1-Minute Sit-to-Stand Test (1MSTS)
This outcome measures the total number of full sit-to-stand movements performed in one minute by participants with spastic hemiplegic cerebral palsy. The aim is to determine whether the 1MSTS is a valid measure of functional exercise performance in this population.
Measured: At baseline (single assessment session)
Distance Walked in the 6-Minute Walk Test (6MWT)
Measures the total distance (in meters) walked in 6 minutes by participants on a 30-meter corridor, in accordance with ATS guidelines. The 6MWT serves as the reference test to compare with the 1MSTS.
Measured: At baseline (single assessment session)
Secondary outcomes (4)
Heart Rate (HR) Before and After Exercise Tests
Heart rate is measured using a pulse oximeter before and after both the 1MSTS and 6MWT to assess cardiovascular response to physical activity.
Measured: Pre-intervention and immediately after the intervention
Oxygen Saturation (SpO2) Before and After Exercise Tests
Peripheral oxygen saturation is recorded before and after each exercise test to monitor oxygenation changes in response to activity.
Measured: Pre-intervention and immediately after the intervention
Systolic and Diastolic Blood Pressure Before and After Exercise Tests
Blood pressure values are recorded before and after the tests using a standard sphygmomanometer to evaluate cardiovascular load.
Measured: Pre-intervention and immediately after the intervention
Perceived Dyspnea and Leg Fatigue Using Modified Borg Scale
Dyspnea and lower extremity fatigue are assessed before and after each test using the Modified Borg Scale (0-10), which evaluates subjective exertion levels.
Measured: Pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start31 Dec 2024
- Primary completion1 Mar 2025
- Study completion1 Jul 2025
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 PalsyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri University
- Responsible party
- Principal investigator, Betul Ergun, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136129
- Sponsor's protocol ID
- SP-1sts6dyt
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ergun B, Baykan Copuroglu O, Baykan M, Gurer F, Abakay H. Functional Exercise Performance in Children with Cerebral Palsy: Is the 1-Minute Sit-to-Stand Test an Alternative to the 6-Minute Walk Test? Phys Occup Ther Pediatr. 2026 Jun 9:1-16. doi: 10.1080/01942638.2026.2682292. Online ahead of print.
PubMed 42264886
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exercise Performance in Children With Cerebral Palsy: Is the One-Minute Sit-to-Stand Test an Alternative to the Six-Minute Walk Test
- ClinicalTrials.gov ID
- NCT07136129
- Acronym / sponsor ID
- SP-1sts6dyt
- Conditions
- Cerebral Palsy, Cerebral Palsy Spastic Hemiplegic
- Keywords
- cerebral palsy, One-Minute Sit-to-Stand Test, Functional Exercise Performance in Cerebral Palsy, Six-Minute Walk Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- Kayseri University
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Aug 2025 (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.
This study investigates the validity of the 1-minute sit-to-stand test (1MSTS) as a practical and time-efficient alternative to the 6-minute walk test (6MWT) for assessing functional exercise capacity in children with spastic cerebral palsy (CP). Children aged 5 to 18 years with spastic hemiplegic CP, classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), will perform both tests on the same day. Cardiopulmonary responses and fatigue will be monitored before and after each test. The study aims to determine whether the 1MSTS can be reliably used in clinical settings as a simpler assessment tool for this population.
Detailed description
This cross-sectional study was conducted between December 2024 and July 2025 at Kayseri City Hospital with children diagnosed with spastic hemiplegic cerebral palsy, aged 5-18 years, classified as Level I or II on the Gross Motor Function Classification System (GMFCS). Children with severe cognitive impairment, additional neurological disorders, or uncontrolled health conditions were excluded.
Participants completed both the 6-minute walk test (6MWT) and the 1-minute sit-to-stand test (1MSTS) on the same day, in random order. Tests were performed twice, and a 1-hour rest was given between them. Cardiovascular and respiratory parameters (heart rate, oxygen saturation, blood pressure), dyspnea, and leg fatigue were measured before and after each test using standard tools (pulse oximeter, sphygmomanometer, Modified Borg Scale).
The 6MWT followed ATS guidelines. The 1MSTS was performed using a height-adjustable chair without armrests, and participants stood up and sat down repeatedly for one minute. The number of completed repetitions was recorded. This study followed the Declaration of Helsinki, and written informed consent was obtained from all participants and their guardians.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic hemiplegic type SP | – | –Individuals between 5 and 18 years of age, diagnosed with spastic hemiplegic type CP and in level I or II according to the Gross Motor Function Classification System (GMFCS) were included. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of children aged between 5 and 18 years who were diagnosed with spastic hemiplegic type cerebral palsy (CP) and were being followed up at the Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital between December 2024 and July 2025. These individuals were classified as Level I or II according to the Gross Motor Function Classification System (GMFCS), indicating relatively high levels of functional mobility. All participants and their legal guardians were informed about the study's purpose and procedures, and written informed consent was obtained. The study was approved and conducted in accordance with the principles of the Declaration of Helsinki.
Key inclusion criteria (2 listed)
- Having spastic hemiplegic CP between 5-18
- Being level 1 and 2 according to KMFSS
Key exclusion criteria (7 listed)
- Having cognitive/mental problems at a level that may prevent communication
- Having genetic and/or neurological problems in addition to CP
- Having uncontrolled heart disease
- Having any infection Removal Criteria
- The child or his/her parents wanting to leave 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.
Primary outcome
Number of Repetitions in the 1-Minute Sit-to-Stand Test (1MSTS)
Time frame: At baseline (single assessment session)
This outcome measures the total number of full sit-to-stand movements performed in one minute by participants with spastic hemiplegic cerebral palsy. The aim is to determine whether the 1MSTS is a valid measure of functional exercise performance in this population.
Distance Walked in the 6-Minute Walk Test (6MWT)
Time frame: At baseline (single assessment session)
Measures the total distance (in meters) walked in 6 minutes by participants on a 30-meter corridor, in accordance with ATS guidelines. The 6MWT serves as the reference test to compare with the 1MSTS.
4 secondary outcomes
Heart Rate (HR) Before and After Exercise Tests
Time frame: Pre-intervention and immediately after the intervention
Oxygen Saturation (SpO2) Before and After Exercise Tests
Time frame: Pre-intervention and immediately after the intervention
Systolic and Diastolic Blood Pressure Before and After Exercise Tests
Time frame: Pre-intervention and immediately after the intervention
Perceived Dyspnea and Leg Fatigue Using Modified Borg Scale
Time frame: Pre-intervention and immediately after the intervention
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 22 Aug 2025.
- Derived from this study: PubMed 42264886Ergun B, Baykan Copuroglu O, Baykan M, Gurer F, Abakay H. Functional Exercise Performance in Children with Cerebral Palsy: Is the 1-Minute Sit-to-Stand Test an Alternative to the 6-Minute Walk Test? Phys Occup Ther Pediatr. 2026 Jun 9:1-16. doi: 10.1080/01942638.2026.2682292. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
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 Cerebral Palsy Spastic Hemiplegic, run by Inonu 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 2 inclusion and 7 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 22 Aug 2025. 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?
Number of Repetitions in the 1-Minute Sit-to-Stand Test (1MSTS) (time frame: At baseline (single assessment session)). The study lists 2 primary outcomes in all. 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 NCT07136129, 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 22 Aug 2025.