Cerebral Palsy (CP)NCT06826131
Determination of the Optimal Cut Off Value of the Modified Ashworth Scale in the Evaluation of Gait Performance and Functional Mobility in Individuals With Cerebral Palsy
An observational study of Cerebral Palsy (CP) and Walking Performance, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The spastic type, which is the most common type of CP, constitutes approximately 75% of individuals. The most prominent physical examination finding in patients with CP is marked tonus changes. Increased tonus and involuntary movement patterns are frequently observed clinically. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy (CP), Walking Performance, Functional Mobility
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2025to 10 May 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: It was observed that the effect size obtained in the reference study was strong (d=1.28). As a result of the power analysis performed considering that an effect size at this level could also be obtained; it was calculated that 95% power could be obtained at 95% confidence level when at least 25 people were included in the study (Freire et al, 2023).
Who may be able to join
- GMFSS:1-2,
- Have the appropriate cognitive level to adapt to the tests to be performed in the study,
- Individuals between the ages of 6-15 who agreed to participate in the study were included.
Who cannot join
- Bone and/or soft tissue surgery on the lower extremities within the last 1 year who had the operation,
- Extensive serious skin injuries, skin infection,
- Lower extremity MAS score > 2,
- Mental retardation,
- Individuals who had botulinum toxin applied to their lower extremities within the last 1 year were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic
Kayseri, 38080
About this study
The spastic type, which is the most common type of CP, constitutes approximately 75% of individuals. The most prominent physical examination finding in patients with CP is marked tonus changes. Increased tonus and involuntary movement patterns are frequently observed clinically. Today, the Modified Ashworth Scale is mostly used in the evaluation of spasticity in individuals. Ashworth scale was defined in 1964 and modified in 1987. This scale was developed to assess muscle tone. Resistance to passive movement is evaluated and scored between 0-4.
Read the detailed description
Cerebral palsy (CP) is one of the common causes of disability in childhood. The prevalence of the disease has been evaluated as 2-3 per 1000 live births on average in various societies. In various prevalence studies conducted in our country, the prevalence of the disease was found to be 1.1- 4.4 per 1000 live births.
CP is a disease with multifactorial etiology. Although antenatal, perinatal and neonatal effects often play a role together, the most important known risk factors are low birth weight and prematurity. Intrauterine infections have been identified as the most important cause of CP etiology in individuals with prematurity and low birth weight. These infections can trigger premature birth and cause damage to the central nervous system, which has not yet completed its development.
In CP, classifications are made according to the extremity involvement, clinical features, etiologies and many different pathogenesis. Currently, the most common and widely used classification is the one defined by Phelps and Perlstein according to the involved extremity and tonus disorder.
- Spastic type: (pyramidal): Monoplegia, Diplegia, Hemiplegia, Triplegia, Tetraplegia B) Dyskinetic type: (Extrapyramidal): Athetoid, Choreic, Choreoathetoid, Dystonic C) Ataxic type D) Hypotonic type E) Mixed type Materials and Methods The study was designed to determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. Patients admitted to the CP outpatient clinic of Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic and Twenty-five individuals who meet the inclusion criteria will be included in the study.
Modified Ashworth Scale 0 : Normal muscle tone. 1 : Slight increase in muscle tone, minimal resistance is felt at the end of joint movement.
1+ : Minimal resistance in less than half of the joint movement. 2 : Significant increased muscle tone throughout the entire movement, but the joint can still be moved easily.
3 : There is significant increased muscle tone throughout the entire movement making passive movement difficult.
4 : The affected muscles are completely rigid, remaining in fixed flexion or extension.
Gross Motor Function Measure Classification System (GMFCS) KMFSS, which is one of the most widely used scales to classify the severity of movement disorders in individuals with CP and to evaluate the current activity levels of the subjects, was developed by Palisano et al. in 1997. In 2012, El et al. conducted a validity and reliability study of the CMFCS for the Turkish population.
Gross motor function classification system Level 1 Walks independently. There is limitation in advanced gross motor skills.
Level 2 Walks without an assistive device. Has limitations when walking in public.
Level 3 Walks with an assistive device. There is limitation while walking in the community.
Level 4 Has limitations. Self-mobile. Transported in the community or uses a wheelchair.
Level 5 Mobilization is severely limited even with assistive technologies. 10 meter walk test: It is used to measure walking speed from functional parameters. A 16-meter walking track is created to perform the test. The first 3 and last 3 meters of this track are completed without taking into account and the measurements are repeated 3 times each. Before the test is performed, starting and ending points are determined on non-slippery ground. The individual starts walking, the stopwatch is started after the first three meters. The stopwatch is stopped at the end of the tenth meter. After the individual walks the last 3 meters, walking is terminated. The completion time of the test is recorded in seconds.
Assessment of Mobility TUG test: It was performed using a standard chair (46 cm high). Patients sat with their backs against the chair. Patients were instructed to get up from the chair without support, walk three meters marked on the floor, turn around, walk back to the chair and sit down again. Patients were told that the test should be performed at a normal pace. The stopwatch was started with the word "start" and stopped when the patient sat down. TUG time was measured in seconds (s).
Five Times Sit and Stand Test: It is used for functional mobility measurements. In the test, the individual sits with arms crossed over the shoulders and back leaning against the chair. With the "go" command, the patient stands up and sits down five times quickly from the standard chair. The elapsed time is measured with a stopwatch.
- Keywords
- cerebral palsy
- 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 |
|---|---|---|
| Cerebral Palsy | Individuals with Cerebral Palsy between the ages of 6-15 with gMFSS:1-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut off value of modified ashworth scale in individuals with CP
To determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start8 Feb 2025
- Primary completion10 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 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
- NCT06826131
- Sponsor's protocol ID
- Ashworth- SP
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 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
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
- Determination of the Optimal Cut Off Value of the Modified Ashworth Scale in the Evaluation of Gait Performance and Functional Mobility in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06826131
- Acronym / sponsor ID
- Ashworth- SP
- Keywords
- cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 13 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 spastic type, which is the most common type of CP, constitutes approximately 75% of individuals. The most prominent physical examination finding in patients with CP is marked tonus changes. Increased tonus and involuntary movement patterns are frequently observed clinically. Today, the Modified Ashworth Scale is mostly used in the evaluation of spasticity in individuals. Ashworth scale was defined in 1964 and modified in 1987. This scale was developed to assess muscle tone. Resistance to passive movement is evaluated and scored between 0-4.
Detailed description
Cerebral palsy (CP) is one of the common causes of disability in childhood. The prevalence of the disease has been evaluated as 2-3 per 1000 live births on average in various societies. In various prevalence studies conducted in our country, the prevalence of the disease was found to be 1.1- 4.4 per 1000 live births.
CP is a disease with multifactorial etiology. Although antenatal, perinatal and neonatal effects often play a role together, the most important known risk factors are low birth weight and prematurity. Intrauterine infections have been identified as the most important cause of CP etiology in individuals with prematurity and low birth weight. These infections can trigger premature birth and cause damage to the central nervous system, which has not yet completed its development.
In CP, classifications are made according to the extremity involvement, clinical features, etiologies and many different pathogenesis. Currently, the most common and widely used classification is the one defined by Phelps and Perlstein according to the involved extremity and tonus disorder.
- Spastic type: (pyramidal): Monoplegia, Diplegia, Hemiplegia, Triplegia, Tetraplegia B) Dyskinetic type: (Extrapyramidal): Athetoid, Choreic, Choreoathetoid, Dystonic C) Ataxic type D) Hypotonic type E) Mixed type Materials and Methods The study was designed to determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. Patients admitted to the CP outpatient clinic of Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic and Twenty-five individuals who meet the inclusion criteria will be included in the study.
Modified Ashworth Scale 0 : Normal muscle tone. 1 : Slight increase in muscle tone, minimal resistance is felt at the end of joint movement.
1+ : Minimal resistance in less than half of the joint movement. 2 : Significant increased muscle tone throughout the entire movement, but the joint can still be moved easily.
3 : There is significant increased muscle tone throughout the entire movement making passive movement difficult.
4 : The affected muscles are completely rigid, remaining in fixed flexion or extension.
Gross Motor Function Measure Classification System (GMFCS) KMFSS, which is one of the most widely used scales to classify the severity of movement disorders in individuals with CP and to evaluate the current activity levels of the subjects, was developed by Palisano et al. in 1997. In 2012, El et al. conducted a validity and reliability study of the CMFCS for the Turkish population.
Gross motor function classification system Level 1 Walks independently. There is limitation in advanced gross motor skills.
Level 2 Walks without an assistive device. Has limitations when walking in public.
Level 3 Walks with an assistive device. There is limitation while walking in the community.
Level 4 Has limitations. Self-mobile. Transported in the community or uses a wheelchair.
Level 5 Mobilization is severely limited even with assistive technologies. 10 meter walk test: It is used to measure walking speed from functional parameters. A 16-meter walking track is created to perform the test. The first 3 and last 3 meters of this track are completed without taking into account and the measurements are repeated 3 times each. Before the test is performed, starting and ending points are determined on non-slippery ground. The individual starts walking, the stopwatch is started after the first three meters. The stopwatch is stopped at the end of the tenth meter. After the individual walks the last 3 meters, walking is terminated. The completion time of the test is recorded in seconds.
Assessment of Mobility TUG test: It was performed using a standard chair (46 cm high). Patients sat with their backs against the chair. Patients were instructed to get up from the chair without support, walk three meters marked on the floor, turn around, walk back to the chair and sit down again. Patients were told that the test should be performed at a normal pace. The stopwatch was started with the word "start" and stopped when the patient sat down. TUG time was measured in seconds (s).
Five Times Sit and Stand Test: It is used for functional mobility measurements. In the test, the individual sits with arms crossed over the shoulders and back leaning against the chair. With the "go" command, the patient stands up and sits down five times quickly from the standard chair. The elapsed time is measured with a stopwatch.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy | – | –Individuals with Cerebral Palsy between the ages of 6-15 with gMFSS:1-2 |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- It was observed that the effect size obtained in the reference study was strong (d=1.28). As a result of the power analysis performed considering that an effect size at this level could also be obtained; it was calculated that 95% power could be obtained at 95% confidence level when at least 25 people were included in the study (Freire et al, 2023).
Key inclusion criteria (3 listed)
- GMFSS:1-2,
- Have the appropriate cognitive level to adapt to the tests to be performed in the study,
- Individuals between the ages of 6-15 who agreed to participate in the study were included.
Key exclusion criteria (5 listed)
- Bone and/or soft tissue surgery on the lower extremities within the last 1 year who had the operation,
- Extensive serious skin injuries, skin infection,
- Lower extremity MAS score > 2,
- Mental retardation,
- Individuals who had botulinum toxin applied to their lower extremities within the last 1 year were excluded.
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
Optimal cut off value of modified ashworth scale in individuals with CP
Time frame: 1 days
To determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
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.
- 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 (CP) and Walking Performance, 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 3 inclusion and 5 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?
Optimal cut off value of modified ashworth scale in individuals with CP (time frame: 1 days). 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 22 Aug 2025.