Cerebral PalsycpNCT05213039
Validity and Reliability of the the Timed 360° Turn Test
An observational study of Cerebral Palsy and Gait, Spastic, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy, Gait, Spastic, Gait Disorders in Children
- What is being tested?
- assessments
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2022to 15 Mar 2024
- How long will I take part?
- 1 Day
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with spastic diparetic and hemiparetic cerebral palsy
Who may be able to join
- Having been diagnosed with CP according to SCPE criteria
- Level ≤ 2 by GMFCS-E\&R
- Children aged 7-18 with CP with a Communication Function Classification System (CFCS) ≤ 3
- Children with a Modified Ashworth Scale (MASH) ≤ 3
- Passive range of motion in the ankle, knee and hip joints
- Individuals with spastic hemiparetic-diparetic CP who can follow verbal commands
- Volunteer to participate in the study
Who cannot join
- Have not had Botox, (Botulinum toxin) or surgery in the last 6 months
- Contracture of ankle and knee joint
- Individuals with hemiparetic-diparetic CP who can follow verbal commands
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, 46100
About this study
Official title: Validity and Reliability of the Timed 360° Turn Test in Children With Cerebral Palsy
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Many children with CP have difficulty in balancing independently, walking, walking on hills/uneven ground, and performing daily physical functions.
Read the detailed description
Abnormal gait patterns and balance problems are common problems in children with CP. As children get older, these impairments in walking abilities become more pronounced. In addition to all these problems, hypertonus, increased stretch reflex, muscle weakness, coactivation of antagonist muscles, posture disorders, proprioception losses, muscle and joint deformities are other factors that cause gait disorders and balance problems in children with CP. At this point, the main purpose of CP rehabilitation is to ensure that the child gains maximum functional independence by achieving optimal developmental potential. Therefore, balance and gait restrictions are important problems in children with CP. For these reasons, the evaluation of gait and balance is of great importance in terms of determining the effectiveness of the physiotherapy program, shaping the program, planning and determining the effectiveness of orthopedic and surgical applications, especially in children with CP who have walking potential. In the literature, gait pathologies in children with CP and easy-to-use, valid and reliable observational gait analyzes that can evaluate gait in the clinic are emphasized.Gait analysis systems including computerized kinetics and kinematics laboratories, electromyography (EMG) and video imaging are the "gold standard" methods used to evaluate the gait of children with CP. However, these evaluation methods are not routinely used in clinics because they are complex, expensive, time-consuming and not easy to apply. In addition to many gait assessment scales, the standing, walking, running and stair climbing sections of Gross Motor Function Measurement (GMFM) are widely used in the clinic to evaluate gait. In addition to all these, performance tests that are commonly used in the clinic, such as the Timed Sit and Go Test, the Up and Down Stair Climbing Test, the 2 Minute Walk Test, and the 6 Minute Walk Test, evaluate the functionality of gait. All these tests are tests that evaluate gait prospectively and cannot fully address the functional status of the child. Therefore, in order to gain and maintain functional independence, the gait problems of the child with CP need to be examined more. In this respect, it provides a different task than normal with the evaluation of rotation, allowing the observation of body perception, trunk stability, balance, correction and protective reactions provided by anterior-posterior cocontraction. This observation can provide the exact determination of the problem that will guide the treatment. The timed 360° turn test is a standard clinical measure used to evaluate dynamic standing balance. When the literature was reviewed, no study was found about the The timed 360° turn test in children with CP. The aim of the study is to examine the validity and reliability of The timed 360° turn test in children with CP.
- Conditions
- Cerebral Palsy, Gait, Spastic, Gait Disorders in Children, Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy
- Being tested
- assessments
- Keywords
- Cerebral Palsy, the timed 360° turn test, validity, reliability
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentsOther
Also called the timed 360° turn test
All of the children with cerebral palsy will be assessed by two different physiotherapist observers. The timed 360° turn test, Expanded and revised Gross Motor Function Classification System (GMFCS-E\&R) for functional motor levels of the subjects, lower extremity muscle tone will be measured with the Modified Ashworth Scale (MASH) at the beginning of the one-time study and recorded. Pediatric Berg Balance Scale, Timed Up and Go Test, Pediatric Functional Reaching test and Modified Four Square Stepping Test, 3m walking back test (3MGYT) will be performed.Evaluations will be made by two separate physiotherapists with at least 5 years of experience in this field. The time it took for individuals to complete activities during the tests with a stopwatch will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| 1/Children with diparetic and hemiparetic cerebral palsy | 1/Children with diparetic and hemiparetic cerebral palsy whose Gross Motor Function Classification System (GMFCS) Level ≤ 2 will be evaulated by two different observers. Receives: Other: assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
the timed 360° turn test
In the timed 360° turn test, any marker, such as a tape or pen, is used to determine the starting point and a stopwatch is used to measure time. Each participant stands up comfortably at the starting point and rotates 360° for both sides. The time begins with the word "begin" and ends when the participants' shoulders look forward again. Each participant completes. The average of 3 trials and 3 trials for each side yields a result. The average score is recorded for the timed 360° turn test performance.
Measured: two different observers' measurements in 2 different days (2 sessions per day on two separate days)
Four Square Step Test (FSST)
The child stands in square 2 facing square 1 in a marked area divided into 4 squares. The child has to take turns stepping on each square as fast as possible: it requires the child to step forward, backward, right, and left in a sequence of 2, 3, 4, 1, 4, 3, 2, and 1, respectively. The necessary equipment is a stopwatch and 4 walking sticks 90 cm long. A square with 4 is formed by laying the canes flat on the ground. If the child cannot complete the series, loses balance or touches the cane during the trial, the trial is repeated.Two FSSTs are completed with the best time taken as a score.Timing begins with the first foot touching the floor in frame 1 and ends with the last foot touching the floor in frame 4. Test performance is measured in seconds (sec) and shorter completion time means better dynamic stability.
Measured: first day of assessment
Pediatric Berg Balance Scale (PBBS)
The test has 14 items of increasing difficulty to test functional skills related to activities of daily living, from sitting to standing on one leg. Each item is scored on a five-point ranking scale ranging from 0 to 4 points, with a maximum score level of 56. A higher score indicates better postural balance.
Measured: first day of assesment
Timed Up and Go Test (TUG)
For the test, the child is seated in a height-adjustable chair. The chair height is adjusted so that the child's feet are in contact with the floor and the knees and hips are flexed to 90 degrees. A distance of 3 meters is marked. When the command is given, the child is asked to get up, walk, return and sit on the chair until the marked area. By starting the time with the start command, the time until sitting is recorded. This test will be repeated 3 times and the average time will be recorded. Increasing time indicates worse dynamic stability.
Measured: first day of assesment
Pediatric Functional Reach test
The child is asked to stand sideways on a wall, with the elbows extended at 90 degrees of shoulder flexion without touching the wall. The first measurement is made in this position. Then, he is asked to reach forward without taking a step. The last point it can reach is recorded. The distance between these two distances is measured in meters and recorded. The test is repeated when stepping or stopping the contact of the foot with the ground. A higher measurement indicates worse balance.
Measured: first day of assesment
Secondary outcomes (3)
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
It is a standard classification system used to classify gross motor functions of children with CP. GMFCS-E\&R classifies levels I to V. Level I indicates the best and V the worst level of motor function.
Measured: first day of assessment
Modified Ashworth Scale (MASH)
It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination. Spasticity of the bilateral hip adductors, hip flexors, knee flexors, ankle plantar flexors (gastro-solues) muscles in the lower extremity will be evaluated once at the beginning of the treatment program. The tone felt in these muscles against passive movement is classified as follows; 0: No increase in tone, 1: Slight increase in tone characterized by catching and relaxation or mild resistance at the end of the ROM, 1+: Slight increase in tone characterized by minimal resistance in the remaining ROM (less than half) after capture, 2: Significant tone over most of the ROM increase, but the involved joint can be moved easily, 3: Significant increase in muscle tone, passive movement is difficult, 4: The involved part is rigid in flexion or extension.
Measured: first day of assessment
Demographic information of the children
age, height, gender, education level, background of physiotherapy and diagnosis will be recorded.
Measured: first day of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start15 Jul 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adıgüzel, PhD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213039
- Sponsor's protocol ID
- KSUFTR1
- Acronym
- cp
- Status last verified
- Mar 2024
- First submitted
- 16 Jan 2022
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Timed 360° Turn Test in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05213039
- Acronym / sponsor ID
- cp / KSUFTR1
- Conditions
- Cerebral Palsy, Gait, Spastic, Gait Disorders in Children, Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy
- Keywords
- Cerebral Palsy, the timed 360° turn test, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 28 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.
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that starts in the early stages of life, causes activity limitation, and consists of movement and posture deficiencies. Children with CP usually have difficulties in mobility, transfer and social participation due to many motor and sensory disorders such as muscle weakness, decreased postural control, balance, spasticity. Many children with CP have difficulty in balancing independently, walking, walking on hills/uneven ground, and performing daily physical functions.
Detailed description
Abnormal gait patterns and balance problems are common problems in children with CP. As children get older, these impairments in walking abilities become more pronounced. In addition to all these problems, hypertonus, increased stretch reflex, muscle weakness, coactivation of antagonist muscles, posture disorders, proprioception losses, muscle and joint deformities are other factors that cause gait disorders and balance problems in children with CP. At this point, the main purpose of CP rehabilitation is to ensure that the child gains maximum functional independence by achieving optimal developmental potential. Therefore, balance and gait restrictions are important problems in children with CP. For these reasons, the evaluation of gait and balance is of great importance in terms of determining the effectiveness of the physiotherapy program, shaping the program, planning and determining the effectiveness of orthopedic and surgical applications, especially in children with CP who have walking potential. In the literature, gait pathologies in children with CP and easy-to-use, valid and reliable observational gait analyzes that can evaluate gait in the clinic are emphasized.Gait analysis systems including computerized kinetics and kinematics laboratories, electromyography (EMG) and video imaging are the "gold standard" methods used to evaluate the gait of children with CP. However, these evaluation methods are not routinely used in clinics because they are complex, expensive, time-consuming and not easy to apply. In addition to many gait assessment scales, the standing, walking, running and stair climbing sections of Gross Motor Function Measurement (GMFM) are widely used in the clinic to evaluate gait. In addition to all these, performance tests that are commonly used in the clinic, such as the Timed Sit and Go Test, the Up and Down Stair Climbing Test, the 2 Minute Walk Test, and the 6 Minute Walk Test, evaluate the functionality of gait. All these tests are tests that evaluate gait prospectively and cannot fully address the functional status of the child. Therefore, in order to gain and maintain functional independence, the gait problems of the child with CP need to be examined more. In this respect, it provides a different task than normal with the evaluation of rotation, allowing the observation of body perception, trunk stability, balance, correction and protective reactions provided by anterior-posterior cocontraction. This observation can provide the exact determination of the problem that will guide the treatment. The timed 360° turn test is a standard clinical measure used to evaluate dynamic standing balance. When the literature was reviewed, no study was found about the The timed 360° turn test in children with CP. The aim of the study is to examine the validity and reliability of The timed 360° turn test in children with CP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Children with diparetic and hemiparetic cerebral palsy | – | Other: assessments1/Children with diparetic and hemiparetic cerebral palsy whose Gross Motor Function Classification System (GMFCS) Level ≤ 2 will be evaulated by two different observers. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with spastic diparetic and hemiparetic cerebral palsy
Key inclusion criteria (7 listed)
- Having been diagnosed with CP according to SCPE criteria
- Level ≤ 2 by GMFCS-E\&R
- Children aged 7-18 with CP with a Communication Function Classification System (CFCS) ≤ 3
- Children with a Modified Ashworth Scale (MASH) ≤ 3
- Passive range of motion in the ankle, knee and hip joints
Key exclusion criteria (3 listed)
- Have not had Botox, (Botulinum toxin) or surgery in the last 6 months
- Contracture of ankle and knee joint
- Individuals with hemiparetic-diparetic CP who can follow verbal commands
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 |
|---|---|---|
| assessmentsAlso: the timed 360° turn testAll of the children with cerebral palsy will be assessed by two different physiotherapist observers. The timed 360° turn test, Expanded and revised Gross Motor Function Classification System (GMFCS-E\&R) for functional motor levels of the subjects, lower extremity muscle tone will be measured with the Modified Ashworth Scale (MASH) at the beginning of the one-time study and recorded. Pediatric Berg Balance Scale, Timed Up and Go Test, Pediatric Functional Reaching test and Modified Four Square Stepping Test, 3m walking back test (3MGYT) will be performed.Evaluations will be made by two separate physiotherapists with at least 5 years of experience in this field. The time it took for individuals to complete activities during the tests with a stopwatch will be recorded. | Other | 1/Children with diparetic and hemiparetic cerebral palsy |
Primary outcome
the timed 360° turn test
Time frame: two different observers' measurements in 2 different days (2 sessions per day on two separate days)
In the timed 360° turn test, any marker, such as a tape or pen, is used to determine the starting point and a stopwatch is used to measure time. Each participant stands up comfortably at the starting point and rotates 360° for both sides. The time begins with the word "begin" and ends when the participants' shoulders look forward again. Each participant completes. The average of 3 trials and 3 trials for each side yields a result. The average score is recorded for the timed 360° turn test performance.
Four Square Step Test (FSST)
Time frame: first day of assessment
The child stands in square 2 facing square 1 in a marked area divided into 4 squares. The child has to take turns stepping on each square as fast as possible: it requires the child to step forward, backward, right, and left in a sequence of 2, 3, 4, 1, 4, 3, 2, and 1, respectively. The necessary equipment is a stopwatch and 4 walking sticks 90 cm long. A square with 4 is formed by laying the canes flat on the ground. If the child cannot complete the series, loses balance or touches the cane during the trial, the trial is repeated.Two FSSTs are completed with the best time taken as a score.Timing begins with the first foot touching the floor in frame 1 and ends with the last foot touching the floor in frame 4. Test performance is measured in seconds (sec) and shorter completion time means better dynamic stability.
Pediatric Berg Balance Scale (PBBS)
Time frame: first day of assesment
The test has 14 items of increasing difficulty to test functional skills related to activities of daily living, from sitting to standing on one leg. Each item is scored on a five-point ranking scale ranging from 0 to 4 points, with a maximum score level of 56. A higher score indicates better postural balance.
Timed Up and Go Test (TUG)
Time frame: first day of assesment
For the test, the child is seated in a height-adjustable chair. The chair height is adjusted so that the child's feet are in contact with the floor and the knees and hips are flexed to 90 degrees. A distance of 3 meters is marked. When the command is given, the child is asked to get up, walk, return and sit on the chair until the marked area. By starting the time with the start command, the time until sitting is recorded. This test will be repeated 3 times and the average time will be recorded. Increasing time indicates worse dynamic stability.
Pediatric Functional Reach test
Time frame: first day of assesment
The child is asked to stand sideways on a wall, with the elbows extended at 90 degrees of shoulder flexion without touching the wall. The first measurement is made in this position. Then, he is asked to reach forward without taking a step. The last point it can reach is recorded. The distance between these two distances is measured in meters and recorded. The test is repeated when stepping or stopping the contact of the foot with the ground. A higher measurement indicates worse balance.
3 secondary outcomes
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Time frame: first day of assessment
Modified Ashworth Scale (MASH)
Time frame: first day of assessment
Demographic information of the children
Time frame: first day of assessment
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 20 Mar 2024.
- 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.
hatice adıgüzel, PhD principal investigator
Kahramanmaras Sutcu Imam 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 Gait, Spastic, run by Kahramanmaras Sutcu Imam 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 7 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 20 Mar 2024. 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?
the timed 360° turn test (time frame: two different observers' measurements in 2 different days (2 sessions per day on two separate days)). The study lists 5 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 20 Mar 2024.