Cerebral PalsycpNCT05229523
Validity and Reliability of the Modified Four Square Step Test (mFSST)
An observational study of Cerebral Palsy and Diplegic Cerebral Palsy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that causes activity limitation resulting from movement and posture deficiencies as a result of a lesion in the immature brain. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy, Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- repeated assessments
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 15 Jan 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
- Diagnosed with CP according to SCPE criteria
- Expanded Gross Motor Function Classification System (GMFCS-E\&R) Level ≤ 2
- 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
- Not having 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 Modified Four Square Step Test (mFSST) in Children With Cerebral Palsy
Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder that causes activity limitation resulting from movement and posture deficiencies as a result of a lesion in the immature brain. 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.Hypertonus and abnormal motor patterns, lack of trunk control and postural disorders adversely affect the physical development of these children. Children with CP show various posture disorders due to proximal muscle strength losses leading to limitations and deficiencies in postural reactions. This leads to losses in reactive and antisipatory postural adjustments, and limits upper extremity functions such as walking, reaching, and eating. For this reason, children with CP have difficulties in maintaining balance while standing or sitting independently, walking, maintaining postural control in various environments such as walking, hills/uneven floors, performing activities of daily living (ADL) and social participation.
Read the detailed description
SP; classified as spastic, dyskinetic, ataxic type. The most common type is the spastic type. The ones with the best functional independence level in this group are; hemiparetic and diparetic SP. In addition to the lower extremities, the upper extremities are affected to a small extent in spastic diparetic CP. Increased lower extremity hypertonus in these children causes gait disturbances and balance problems such as fingertip, jumping, scissoring, bent knee gait. In patients with hemiparetic CP, on the other hand, hypertonus, spasticity, inadequacy in trunk control and motor losses are usually observed in one half of the body. In hemiparetic patients, the upper extremity is usually more affected than the lower extremity, and gait pathologies and balance problems are seen in different patterns. Abnormal gait patterns and balance problems are common and common problems in children with CP. As children grow, these disorders in gait become more pronounced as a result of increased hypertonus due to their taller growth. In addition, increased hypertonus and 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 these children. 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. These measurements are of great importance in clinical practice. 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.On the other hand, performance tests commonly used in the clinic such as the Timed Up and Go Test (TUG), the Timed Up and Down Stairs Test, the 2 Minute Walk Test, and the 6 Minute Walk Test evaluate the functionality of walking. All these tests are tests that evaluate gait prospectively and cannot fully address the child's functional status and balance problems. 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, with a test such as the Modified Four-Square Step Test (mFSST), it provides a different task than normal by assessing the sustainability of postural control, which provides balance parameters by changing direction, and enables the observation of body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions. It is performed using tape instead of canes, according to the Four Square Step test (FSST), which is frequently used in SP and found to be valid and reliable. The mFSST, a modified version of the FSST, could allow more children with CP with balance problems to complete the test while retaining the essential components of obstacle avoidance and the need for individuals to step forward, backward, and to either side. In this test, while passing over an object, the height of the object is reduced. The aim of the study is to examine the validity and reliability of the Modified Four Square Step test (mFSST) in children with CP.
- Conditions
- Cerebral Palsy, Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy, Gait Disorders, Neurologic, Gait, Spastic, Gait Disorders in Children
- Being tested
- repeated assessments
- Keywords
- Cerebral Palsy, gait, Modified Four Square Step Test (mFSST), reliability, validity
- 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.
repeated assessmentsOther
Also called validity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsy
validity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsy with the tests of Pediatric Berg Balance Scale (PBSS), Timed Up and Go Test (TUG), Pediatric Functional Reaching Test (PFUT)
| Study group | Role | What they receive |
|---|---|---|
| 1/Children with diparetic and hemiparetic cerebral palsy | 1/Children with diparetic and hemiparetic cerebral palsy aged 7-18 years with the Communication Function Classification System (CFCS) level ≤ 3 and Extended Gross Motor Function Classification System (GMFCS-E\&R) level ≤ 2 Receives: Other: repeated assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Four Square Step Test (mFSST)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Measured: day 1 (observer1)
Modified Four Square Step Test (mFSST)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Measured: day 1 (observer2)
Modified Four Square Step Test (mFSST)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Measured: day 2 (observer2)
Modified Four Square Step Test (mFSST)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Measured: day 2 (observer1)
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: day 1 (observer1)
Timed Up and Go Test (TUG)
It is a reliable test that measures walking speed, postural control, functional mobility and balance. 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 balance.
Measured: day 1 (observer1)
Pediatric Functional Reach test (PFRT)
Necessary environmental conditions are provided away from external stimuli. Then, the child is asked to stand sideways on a wall, with the elbows extended in 90 degrees 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. Increasing the measured distance indicates worse balance.
Measured: day 1 (observer1)
Four Square Stepping 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 fails to complete the series, loses balance, or touches the cane during the trial, the trial is repeated. 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: day 1 (observer1)
Secondary outcomes (2)
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 classifies levels I to V. Level I indicates the best and V the worst level of motor function.
Measured: day 1 (observer1)
Modified Ashworth Scale (MAS)
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: day 1 (observer1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 May 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 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
- NCT05229523
- Sponsor's protocol ID
- KSUFTR2
- 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 Modified Four Square Step Test (mFSST) in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05229523
- Acronym / sponsor ID
- cp / KSUFTR2
- Conditions
- Cerebral Palsy, Diplegic Cerebral Palsy, Hemiplegic Cerebral Palsy, Gait Disorders, Neurologic, Gait, Spastic, Gait Disorders in Children
- Keywords
- Cerebral Palsy, gait, Modified Four Square Step Test (mFSST), reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 8 Feb 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 causes activity limitation resulting from movement and posture deficiencies as a result of a lesion in the immature brain. 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.Hypertonus and abnormal motor patterns, lack of trunk control and postural disorders adversely affect the physical development of these children. Children with CP show various posture disorders due to proximal muscle strength losses leading to limitations and deficiencies in postural reactions. This leads to losses in reactive and antisipatory postural adjustments, and limits upper extremity functions such as walking, reaching, and eating. For this reason, children with CP have difficulties in maintaining balance while standing or sitting independently, walking, maintaining postural control in various environments such as walking, hills/uneven floors, performing activities of daily living (ADL) and social participation.
Detailed description
SP; classified as spastic, dyskinetic, ataxic type. The most common type is the spastic type. The ones with the best functional independence level in this group are; hemiparetic and diparetic SP. In addition to the lower extremities, the upper extremities are affected to a small extent in spastic diparetic CP. Increased lower extremity hypertonus in these children causes gait disturbances and balance problems such as fingertip, jumping, scissoring, bent knee gait. In patients with hemiparetic CP, on the other hand, hypertonus, spasticity, inadequacy in trunk control and motor losses are usually observed in one half of the body. In hemiparetic patients, the upper extremity is usually more affected than the lower extremity, and gait pathologies and balance problems are seen in different patterns. Abnormal gait patterns and balance problems are common and common problems in children with CP. As children grow, these disorders in gait become more pronounced as a result of increased hypertonus due to their taller growth. In addition, increased hypertonus and 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 these children. 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. These measurements are of great importance in clinical practice. 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.On the other hand, performance tests commonly used in the clinic such as the Timed Up and Go Test (TUG), the Timed Up and Down Stairs Test, the 2 Minute Walk Test, and the 6 Minute Walk Test evaluate the functionality of walking. All these tests are tests that evaluate gait prospectively and cannot fully address the child's functional status and balance problems. 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, with a test such as the Modified Four-Square Step Test (mFSST), it provides a different task than normal by assessing the sustainability of postural control, which provides balance parameters by changing direction, and enables the observation of body perception, trunk stability provided by anterior-posterior cocontraction, balance, correction and protective reactions. It is performed using tape instead of canes, according to the Four Square Step test (FSST), which is frequently used in SP and found to be valid and reliable. The mFSST, a modified version of the FSST, could allow more children with CP with balance problems to complete the test while retaining the essential components of obstacle avoidance and the need for individuals to step forward, backward, and to either side. In this test, while passing over an object, the height of the object is reduced. The aim of the study is to examine the validity and reliability of the Modified Four Square Step test (mFSST) 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: repeated assessments1/Children with diparetic and hemiparetic cerebral palsy aged 7-18 years with the Communication Function Classification System (CFCS) level ≤ 3 and Extended Gross Motor Function Classification System (GMFCS-E\&R) level ≤ 2 |
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)
- Diagnosed with CP according to SCPE criteria
- Expanded Gross Motor Function Classification System (GMFCS-E\&R) Level ≤ 2
- 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)
- Not having 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 |
|---|---|---|
| repeated assessmentsAlso: validity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsyvalidity and reliability of the Modified Four Square Step Test (mFSST) in children with cerebral palsy with the tests of Pediatric Berg Balance Scale (PBSS), Timed Up and Go Test (TUG), Pediatric Functional Reaching Test (PFUT) | Other | 1/Children with diparetic and hemiparetic cerebral palsy |
Primary outcome
Modified Four Square Step Test (mFSST)
Time frame: day 1 (observer1)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Modified Four Square Step Test (mFSST)
Time frame: day 1 (observer2)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Modified Four Square Step Test (mFSST)
Time frame: day 2 (observer2)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Modified Four Square Step Test (mFSST)
Time frame: day 2 (observer1)
It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and it is written up to 4 in a clockwise direction. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then back to the number (4). He is then asked to take steps from 4 to 1 again. The time is recorded. High time indicates worse dynamic stability.
Pediatric Berg Balance Scale (PBBS)
Time frame: day 1 (observer1)
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: day 1 (observer1)
It is a reliable test that measures walking speed, postural control, functional mobility and balance. 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 balance.
Pediatric Functional Reach test (PFRT)
Time frame: day 1 (observer1)
Necessary environmental conditions are provided away from external stimuli. Then, the child is asked to stand sideways on a wall, with the elbows extended in 90 degrees 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. Increasing the measured distance indicates worse balance.
Four Square Stepping Test (FSST)
Time frame: day 1 (observer1)
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 fails to complete the series, loses balance, or touches the cane during the trial, the trial is repeated. 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.
2 secondary outcomes
Expanded and revised Gross Motor Function Classification System (GMFCS-E&R)
Time frame: day 1 (observer1)
Modified Ashworth Scale (MAS)
Time frame: day 1 (observer1)
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 Diplegic Cerebral Palsy, 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?
Modified Four Square Step Test (mFSST) (time frame: day 1 (observer1)). The study lists 8 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.