Cerebral Palsy (CP)NCT06831591
Dubousset Functional Test: An Investigation of Its Validity and Reliability in Children With GMFCS I-II Spastic Cerebral Palsy
An observational study of Cerebral Palsy (CP) and Reliability and Validity, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
the investigators hypothesize that over time, it may lead to loss of functional capacity in children with CP. In this context, our study aims to examine the validity and reliability of the four-component Dubousset Functional Test (DFT), which is used to objectively measure the functional capacity of children with… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP), Reliability and Validity, Functional Test
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2025to 1 Mar 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: G-Power 3.1.9.2 program was used to estimate the required sample size and it was observed that the effect obtained in the reference study was at a strong level (d = 0.731) (Lexell JE, Downham DY, 2005). As a result of the power analysis performed with the assumption that this effect size could be obtained again, it was calculated that 95% statistical power would be obtained at 95% confidence level if at least 33 people were included in the study.
Who may be able to join
- 12-18 years old,
- Diagnosed with spastic cerebral palsy,
- GMFCS level I-II,
- At the appropriate cognitive level to adapt to the tests to be performed in the study,
- Completed primary school level,
- Individuals who agree to participate in the study will be recruited.
Who cannot join
- Bone and/or soft tissue surgery on the lower extremities within the last 1 year,
- Inability to perform a task due to sensory, cognitive or other problems,
- Ataxic CP, Dyskinetic CP, Hypotonic CP, Mixed type CP groups will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic
Kayseri, 38000
About this study
the investigators hypothesize that over time, it may lead to loss of functional capacity in children with CP. In this context, our study aims to examine the validity and reliability of the four-component Dubousset Functional Test (DFT), which is used to objectively measure the functional capacity of children with spastic CP, in children with spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) I-II level.
Read the detailed description
Cerebral Palsy (CP) is a group of permanent disorders in the development of movement and posture due to damage to the fetal or infant brain that is not progressive but leads to limitations in activity and participation over time (Rosenbaum et al, 2007). Although the lesion in CP is not progressive, children's participation in daily life activities and social roles is limited due to secondary problems. In this sense, CP is the childhood problem that occurs in childhood and limits mobility the most (McIntyre et al, 2022).
According to the most recent classification, CP is divided into four categories: spastic, ataxic, dyskinetic and unclassifiable (Cans, C. (2000). Although spastic type CP is characterized with spasticity and hypertonus, various disorders such as weakness in muscle strength, selective motor loss, bilateral coordination failure, sensory problems, mirror movements, and inadequacy in trunk control may be observed (Cans et al., 2007). Hemiplegic spastic CP is a type in which the right or left half of the body is affected and the upper extremities are affected more than the lower extremities (Kitai et al, 2016 ). It is reported that there are 18 million children with CP worldwide and 200 thousand children with CP in Turkey and approximately 75%-85% of them have spastic CP (Cerebral Palsy Guide, 2024). In this sense, spastic CP is the most common type.
In children with spastic CP, spasticity is generally observed in the muscles of the extremities and hypotonia is generally observed in the trunk muscles. The muscles in which spasticity is most commonly observed include shoulder extensor, shoulder adductor and shoulder internal rotator muscles, elbow flexor muscles, forearm pronator muscles, wrist and finger flexor muscles, hip flexor, adductor and internal rotator muscles, knee flexor muscles and ankle plantar flexor muscles (Davids et al.).
In children with spastic CP, co-contraction of antagonist and agonist muscles is preserved instead of normal reciprocal relaxation (Aloraini et al, 2020). Although spasticity is the prominent feature, many problems such as stereotypic movement patterns, increased deep tendon reflexes, hyperreflexia and clonus, inadequacy in balance and protective reactions, combined reactions, selective motor control impairment, and decreased active and passive normal range of motion are associated. Increased muscle tone also causes secondary joint deformities, muscle contractures, posture and gait disorders. The most common types in children with spastic CP are as follows; 30-40% diparetic, 20-30% hemiparetic and 10-15% quadriparetic type CP (Vova, J. 2022).
- Dubousset Functional Test (DFT): A conceptual four-component global functional assessment test - Dubousset Functional Test (DFT) - will be applied to objectively measure the functional capacity of children with spastic cerebral palsy (Diebo et al, 2019). These four components are as follows.
- Get Up and Walk Test: Children with spastic cerebral palsy will get up unassisted from a seated position in a chair without arms, walk 5 meters (500 cm), turn around, walk back 5 meters and sit down again unassisted.
- Step Test: Children with spastic cerebral palsy will climb three steps of stairs from a starting position 50 cm away, turn around on the third step and walk back down.
- Sit and stand test: Children with spastic cerebral palsy will sit on the floor from a standing position with assistance if necessary and stand up again with assistance if necessary.
- Dual Task Test: Children with spastic cerebral palsy will walk 5 meters forward, turn around and walk 5 meters backward while doing a memory exercise (counting down from 50 in 2 intervals).
Patients will rest for 1 hour and Dubousset Functional Test will be performed again.
- Gross Motor Function Classification System (GMFCS) Gross motor function classification system. Developed in 1997 by Palisano et al. It was found to be valid and reliable in individuals with cerebral palsy (Palisano, 1997). Günel et al. translated the Turkish version and the evaluation form is available on the online website (Palisano, 2007).
The GMFCS used for CP is based on the child's self-initiated movement, focusing on sitting, shifting and mobility. In the five-level system, the significance of the observed differences in daily life is the main criterion. Differences are based on functional limitations, the need for hand-held mobility aids (walker, crutches or cane) or a wheelchair, and partly on the quality of movement. Expanded in 2007, the GMFCS covers the age range 12-18 years and emphasizes the World Health Organization (WHO) international classification concepts of function, disability and health (Palisano, 2007).
General characteristics of the levels
- LEVEL-1: Can walk without limitation.
- LEVEL-2: Experiences some limitations while walking.
- LEVEL-3: Walks with hand-held mobility aids.
- LEVEL-4: Movement alone is limited; may need a motorized mobility device.
- LEVEL-5: Moves with assistance in a manual wheelchair.
Statistical Method IBM SPSS 24.0 (Mac version) will be used for statistical analysis. Mean and standard deviation will be used for descriptive quantitative data and numbers and percentages will be used for qualitative data. The suitability of the data for normal distribution will be determined by Kolmogrov-Smirnov test. Repeated Measurements ANOVA, One Way ANOVA and Tukey HSD tests will be used for multiple comparisons. Chi-square test will be used in the statistical evaluation of categorical variables (frequency, percentage calculation). Significance level will be accepted as p<0.05.
The test-retest reliability of the subcomponents of the Dubousset function test will be tested with the 2-way random effect intraclass correlation coefficient (ICC) at 95% confidence interval. The ICC results will be expressed as suggested by Bland and Altman (≤0.20 poor, 0.21-0.40 fair, 0.41-0.60 moderate, 0.61-0.80 good, and 0.81-1.00 excellent). To determine the standard error of measurement (SEM) levels and the precision of the measurements, the SEM value will be calculated using the formula SEM = SD x.
- Conditions
- Cerebral Palsy (CP), Reliability and Validity, Functional Test, Gross Motor Function Classification System (GMFCS) Level I,II
- 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 |
|---|---|---|
| gmfcs 1-2 | It was conducted on individuals diagnosed with spastic CP at GMFCS level I-II. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dubousset Functional Test
Investigation of the Validity and Reliability of the Dubousset Functional Test in Children with GMFCS I-II Spastic Cerebral Palsy. It is a test used to objectively measure the functional capacity of children with spastic CP. The DFT includes 4 different test components. After the patients are administered the DFT, they will rest for 1 hour and then the DFT will be administered again. The time to complete the tests will be recorded in seconds and evaluated before and after.
Measured: 1 days
Secondary outcomes (5)
TUG (Timed Up and Go) Test
The TUG test is a tool designed to assess dynamic balance, walking speed and mobility. To complete the test, participants are required to get up from a chair with armrests, walk 3 m, turn, walk back and sit on the chair. The completion time of the test is recorded with a stopwatch
Measured: Day 1
Dual Task TUG (Additional Cognitive Task)
During the TUG test, counting backwards by twos from 50 will be used as an additional cognitive task. When the test had to be repeated, individuals continued counting from the number they had left off. Counting errors will be ignored.
Measured: Day 1
Three-Meter Backward Walk Test (3MBWT)
Participant walks backward along a 3-meter line marked with tape as quickly as possible, keeping heels aligned with the line. Completion time is measured.
Measured: day 1
Functional Reach Test
Standing with one arm flexed to 90°, participant reaches forward as far as possible without moving the feet. The distance between the starting and farthest fingertip positions is recorded. The test is repeated three times, and the average is used.
Measured: day 1
Pediatric Balance Scale
Balance performance is assessed using the Pediatric Balance Scale, which consists of 14 items scored from 0 to 4. Higher scores indicate better balance.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start24 Jan 2025
- Primary completion1 Feb 2025
- Study completion1 Mar 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 Palsy (CP)Studies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Ergun, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831591
- Sponsor's protocol ID
- Dobousset
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ergun B, Baykan M, Baykan Copuroglu O, Abakay H, Guc A, Karabulut R. Functional motor performance and reliability of the Dubousset Functional Test in ambulatory children with spastic cerebral palsy. Dev Neurorehabil. 2025 Nov;28(8):304-310. doi: 10.1080/17518423.2026.2626754. Epub 2026 Feb 7.
PubMed 41653057
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dubousset Functional Test: An Investigation of Its Validity and Reliability in Children With GMFCS I-II Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06831591
- Acronym / sponsor ID
- Dobousset
- Conditions
- Cerebral Palsy (CP), Reliability and Validity, Functional Test, Gross Motor Function Classification System (GMFCS) Level I,II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Feb 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.
the investigators hypothesize that over time, it may lead to loss of functional capacity in children with CP. In this context, our study aims to examine the validity and reliability of the four-component Dubousset Functional Test (DFT), which is used to objectively measure the functional capacity of children with spastic CP, in children with spastic cerebral palsy at Gross Motor Function Classification System (GMFCS) I-II level.
Detailed description
Cerebral Palsy (CP) is a group of permanent disorders in the development of movement and posture due to damage to the fetal or infant brain that is not progressive but leads to limitations in activity and participation over time (Rosenbaum et al, 2007). Although the lesion in CP is not progressive, children's participation in daily life activities and social roles is limited due to secondary problems. In this sense, CP is the childhood problem that occurs in childhood and limits mobility the most (McIntyre et al, 2022).
According to the most recent classification, CP is divided into four categories: spastic, ataxic, dyskinetic and unclassifiable (Cans, C. (2000). Although spastic type CP is characterized with spasticity and hypertonus, various disorders such as weakness in muscle strength, selective motor loss, bilateral coordination failure, sensory problems, mirror movements, and inadequacy in trunk control may be observed (Cans et al., 2007). Hemiplegic spastic CP is a type in which the right or left half of the body is affected and the upper extremities are affected more than the lower extremities (Kitai et al, 2016 ). It is reported that there are 18 million children with CP worldwide and 200 thousand children with CP in Turkey and approximately 75%-85% of them have spastic CP (Cerebral Palsy Guide, 2024). In this sense, spastic CP is the most common type.
In children with spastic CP, spasticity is generally observed in the muscles of the extremities and hypotonia is generally observed in the trunk muscles. The muscles in which spasticity is most commonly observed include shoulder extensor, shoulder adductor and shoulder internal rotator muscles, elbow flexor muscles, forearm pronator muscles, wrist and finger flexor muscles, hip flexor, adductor and internal rotator muscles, knee flexor muscles and ankle plantar flexor muscles (Davids et al.).
In children with spastic CP, co-contraction of antagonist and agonist muscles is preserved instead of normal reciprocal relaxation (Aloraini et al, 2020). Although spasticity is the prominent feature, many problems such as stereotypic movement patterns, increased deep tendon reflexes, hyperreflexia and clonus, inadequacy in balance and protective reactions, combined reactions, selective motor control impairment, and decreased active and passive normal range of motion are associated. Increased muscle tone also causes secondary joint deformities, muscle contractures, posture and gait disorders. The most common types in children with spastic CP are as follows; 30-40% diparetic, 20-30% hemiparetic and 10-15% quadriparetic type CP (Vova, J. 2022).
- Dubousset Functional Test (DFT): A conceptual four-component global functional assessment test - Dubousset Functional Test (DFT) - will be applied to objectively measure the functional capacity of children with spastic cerebral palsy (Diebo et al, 2019). These four components are as follows.
- Get Up and Walk Test: Children with spastic cerebral palsy will get up unassisted from a seated position in a chair without arms, walk 5 meters (500 cm), turn around, walk back 5 meters and sit down again unassisted.
- Step Test: Children with spastic cerebral palsy will climb three steps of stairs from a starting position 50 cm away, turn around on the third step and walk back down.
- Sit and stand test: Children with spastic cerebral palsy will sit on the floor from a standing position with assistance if necessary and stand up again with assistance if necessary.
- Dual Task Test: Children with spastic cerebral palsy will walk 5 meters forward, turn around and walk 5 meters backward while doing a memory exercise (counting down from 50 in 2 intervals).
Patients will rest for 1 hour and Dubousset Functional Test will be performed again.
- Gross Motor Function Classification System (GMFCS) Gross motor function classification system. Developed in 1997 by Palisano et al. It was found to be valid and reliable in individuals with cerebral palsy (Palisano, 1997). Günel et al. translated the Turkish version and the evaluation form is available on the online website (Palisano, 2007).
The GMFCS used for CP is based on the child's self-initiated movement, focusing on sitting, shifting and mobility. In the five-level system, the significance of the observed differences in daily life is the main criterion. Differences are based on functional limitations, the need for hand-held mobility aids (walker, crutches or cane) or a wheelchair, and partly on the quality of movement. Expanded in 2007, the GMFCS covers the age range 12-18 years and emphasizes the World Health Organization (WHO) international classification concepts of function, disability and health (Palisano, 2007).
General characteristics of the levels
- LEVEL-1: Can walk without limitation.
- LEVEL-2: Experiences some limitations while walking.
- LEVEL-3: Walks with hand-held mobility aids.
- LEVEL-4: Movement alone is limited; may need a motorized mobility device.
- LEVEL-5: Moves with assistance in a manual wheelchair.
Statistical Method IBM SPSS 24.0 (Mac version) will be used for statistical analysis. Mean and standard deviation will be used for descriptive quantitative data and numbers and percentages will be used for qualitative data. The suitability of the data for normal distribution will be determined by Kolmogrov-Smirnov test. Repeated Measurements ANOVA, One Way ANOVA and Tukey HSD tests will be used for multiple comparisons. Chi-square test will be used in the statistical evaluation of categorical variables (frequency, percentage calculation). Significance level will be accepted as p<0.05.
The test-retest reliability of the subcomponents of the Dubousset function test will be tested with the 2-way random effect intraclass correlation coefficient (ICC) at 95% confidence interval. The ICC results will be expressed as suggested by Bland and Altman (≤0.20 poor, 0.21-0.40 fair, 0.41-0.60 moderate, 0.61-0.80 good, and 0.81-1.00 excellent). To determine the standard error of measurement (SEM) levels and the precision of the measurements, the SEM value will be calculated using the formula SEM = SD x.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gmfcs 1-2 | – | –It was conducted on individuals diagnosed with spastic CP at GMFCS level I-II. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- G-Power 3.1.9.2 program was used to estimate the required sample size and it was observed that the effect obtained in the reference study was at a strong level (d = 0.731) (Lexell JE, Downham DY, 2005). As a result of the power analysis performed with the assumption that this effect size could be obtained again, it was calculated that 95% statistical power would be obtained at 95% confidence level if at least 33 people were included in the study.
Key inclusion criteria (6 listed)
- 12-18 years old,
- Diagnosed with spastic cerebral palsy,
- GMFCS level I-II,
- At the appropriate cognitive level to adapt to the tests to be performed in the study,
- Completed primary school level,
Key exclusion criteria (3 listed)
- Bone and/or soft tissue surgery on the lower extremities within the last 1 year,
- Inability to perform a task due to sensory, cognitive or other problems,
- Ataxic CP, Dyskinetic CP, Hypotonic CP, Mixed type CP groups will not be included 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.
Primary outcome
Dubousset Functional Test
Time frame: 1 days
Investigation of the Validity and Reliability of the Dubousset Functional Test in Children with GMFCS I-II Spastic Cerebral Palsy. It is a test used to objectively measure the functional capacity of children with spastic CP. The DFT includes 4 different test components. After the patients are administered the DFT, they will rest for 1 hour and then the DFT will be administered again. The time to complete the tests will be recorded in seconds and evaluated before and after.
5 secondary outcomes
TUG (Timed Up and Go) Test
Time frame: Day 1
Dual Task TUG (Additional Cognitive Task)
Time frame: Day 1
Three-Meter Backward Walk Test (3MBWT)
Time frame: day 1
Functional Reach Test
Time frame: day 1
Pediatric Balance Scale
Time frame: day 1
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 28 Aug 2025.
- Derived from this study: PubMed 41653057Ergun B, Baykan M, Baykan Copuroglu O, Abakay H, Guc A, Karabulut R. Functional motor performance and reliability of the Dubousset Functional Test in ambulatory children with spastic cerebral palsy. Dev Neurorehabil. 2025 Nov;28(8):304-310. doi: 10.1080/17518423.2026.2626754. Epub 2026 Feb 7.
- 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.
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 (CP) and Reliability and Validity, 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 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 28 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?
Dubousset Functional Test (time frame: 1 days). 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 NCT06831591, 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 28 Aug 2025.