Cerebral PalsyNCT05962749
The Relationship of Forward and Backward Walking with SMC, Trunk Control and Balance in Children with Cerebral Palsy
An observational study of Cerebral Palsy and Balance, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Balance, Gait Disorders in Children
- What is being tested?
- Assessment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2023to 15 Mar 2024
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who apply for rehabilitation in Special Education and Rehabilitation Centers affiliated to the Ministry of National Education in the city of Antalya will be included in the study.
Who may be able to join
- To be diagnosed with cerebral palsy by a specialist physician
- Gross Motor Function Classification System (GMFCS) level I or II
- Children with lower extremity muscles level ≤ 2 according to the Modified Ashworth Scale (MAS)
- Ability to follow verbal commands
- Modified Ashworth Scale (MAS) Level ≤2
- Complete passive range of motion in the ankle and knee joints
- Agree to participate in the study (with parent and child consent)
Who cannot join
- Having had Botox (Botulinum toxin) or a surgical operation in the last 6 months
- Having contractures in the ankle and knee joints that affect walking
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Antalya, Alanya, 07425
About this study
Official title: The Relationship of Forward and Backward Walking with Selective Motor Control, Trunk Control and Balance in Children with Cerebral Palsy
Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their voluntary participation.
To evaluate gait, the 3-Meter Backward Walking Test (3MBWT) and the 10-Meter Walk Test (10MWT) will be performed on a flat. The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective motor control in the lower extremity (hip, knee, ankle, subtalar, and toe joints). To evaluate trunk control, the Trunk Control Measurement Scale (TCMS) will be applied in a sitting position. For balance assessment, the Pediatric Balance Scale will be used to reflect activities of daily living. To assess functional independence, the Pediatric Functional Independence Measure (WeeFIM) will be applied. The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity.
Read the detailed description
Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. The study will be conducted at the Özel Özgün Kardelen Special Education and Rehabilitation Center, affiliated with the Ministry of National Education in Antalya. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their voluntary participation.
To evaluate gait, the 3-Meter Backward Walking Test (3MBWT) and the 10-Meter Walk Test (10MWT) will be performed on a flat, obstacle-free track measuring 3 meters and 10 meters in length. The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective motor control in the lower extremity (hip, knee, ankle, subtalar, and toe joints). To evaluate trunk control, the Trunk Control Measurement Scale (TCMS) will be applied in a sitting position.
For balance assessment, the Pediatric Balance Scale, consisting of 14 items with increasing difficulty from a sitting position to standing on one leg, will be used to reflect activities of daily living. To assess functional independence, the Pediatric Functional Independence Measure (WeeFIM), which includes 6 sections and 18 items, will be applied. The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity.
Each child will be assessed only once. Statistical analyses for the study will be conducted using the Statistical Package for Social Sciences (SPSS) Version 21.0 (SPSS Inc., Chicago, IL, USA). Data distribution will be examined using the Shapiro-Wilk Test. Variables with normal distribution will be presented as mean ± standard deviation, while non-normally distributed variables will be presented as median (IQR). Categorical variables will be expressed as frequency and percentage (%). The correlation between the assessment results in the cases will be determined based on the normality of the distribution. The statistical error level will be set at p<0.05.
- Conditions
- Cerebral Palsy, Balance, Gait Disorders in Children
- Being tested
- Assessment
- Keywords
- Cerebral Palsy, Backward Walking, Selective Motor Control, Trunk Control, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS)
| Study group | Role | What they receive |
|---|---|---|
| Children With Cerebral Palsy | Not described Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 meter backward walk test (3MBWT)
The 3-Meter Backward Walk Test (3MBWT) measures the time it takes for a person to walk 3 meters backward. This test assesses balance, coordination, and leg strength, making it especially useful for individuals at risk of falling or those with neurological issues. During the test, the participant is timed while walking backward over a flat 3-meter distance. Completing the distance quickly and safely indicates good balance and backward walking ability, while taking longer may suggest potential issues with balance or motor control. This simple yet effective test is used in clinical settings to evaluate functional mobility and monitor progress over time.
Measured: First day
10 meter walk test (10MWT)
The 10-Meter Walk Test (10MWT) measures the time it takes for a person to walk a distance of 10 meters at their comfortable walking pace. This test is widely used to assess walking speed, gait, and functional mobility, and it can be particularly beneficial for individuals with mobility impairments, including those with neurological conditions or musculoskeletal issues. During the test, the participant is timed while walking the 10-meter distance, with the time recorded starting when the participant's foot crosses the starting line and stopping when they cross the finish line. A shorter completion time indicates better walking speed and mobility, while longer times may suggest difficulties in gait or increased risk of falls. The 10MWT is a straightforward and effective tool used in clinical settings to evaluate functional mobility and track changes over time.
Measured: First day
Secondary outcomes (5)
Selective Control Assessment of the Lower Extremities (SCALE)
While applying the Selective Control Assessment of the Lower Extremities (SCALE), the child is asked to perform specific isolated movement patterns at the hip, knee, ankle, subtalar, and toe joints. The clinician scores the selective motor control of each joint based on the child's ability to perform isolated movements. The child receives 2 points if they can move the tested joint in isolation, 1 point if mirror movements occur, indicating impaired selectivity in the untested joint, and 0 points if no movement occurs in the tested joint or if mass-synergy patterns are present. A low score on the SCALE indicates poor selective motor control in the lower extremities.
Measured: First day
Trunk Control Measurement Scale (TCMS)
The Trunk Control Measurement Scale (TCMS) is a clinical tool used to assess trunk control and sitting balance during functional activities. It consists of 15 items that evaluate a person's ability to maintain trunk stability in different positions and movements, making it particularly useful for individuals with neurological conditions, such as stroke or cerebral palsy. During the test, the participant is asked to perform various tasks, such as reaching, turning, and maintaining balance while sitting. Each item is scored, contributing to a total score, with higher scores indicating better trunk control and balance.
Measured: First day
Pediatric Balance Scale (PBS)
The 'Pediatric Balance Scale (PBS)' 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 ordinal scale ranging from 0 to 4 points, with a maximum score level of 56. Higher scores indicate better balance.
Measured: First day
Functional Independence Measure for Children (WeeFIM)
The 'Functional Independence Measure for Children (WeeFIM)' has 6 sections, namely sphincter control, self-care, communication, locomotion, social cognition and transfers. There are a total of 18 items in these sections and each item is scored from 1 to 7. Scoring is done by paying attention to whether the individual performs the specified function on time, receives help or needs an assistive device. If the desired function is performed completely with help, 1 point is given; if the individual performs it completely independently, safely and at the appropriate time, 7 points are given. Accordingly, the individual receives at least 18 points, which means that he/she is fully dependent. The maximum full score that can be obtained from the scale is 126, which means that the individual is fully independent.
Measured: First day
Modified Ashworth Scale (MAS)
The 'Modified Ashworth Scale (MAS)' scores spasticity on a scale ranging from "0" to "4" according to the definition of velocity-dependent spasticity. High MAS score indicates severe spasticity.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start17 Jul 2023
- 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
- Other
- Time perspective
- Other
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Keklikci, Alanya Alaaddin Keykubat University
- Investigators
- Ebru Keklikci, Res. Assist., Principal investigator, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962749
- Sponsor's protocol ID
- 2023-743
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2023
- Last updated
- 8 Nov 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Forward and Backward Walking with Selective Motor Control, Trunk Control and Balance in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05962749
- Acronym / sponsor ID
- 2023-743
- Conditions
- Cerebral Palsy, Balance, Gait Disorders in Children
- Keywords
- Cerebral Palsy, Backward Walking, Selective Motor Control, Trunk Control, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 27 Jul 2023 (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.
Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their voluntary participation.
To evaluate gait, the 3-Meter Backward Walking Test (3MBWT) and the 10-Meter Walk Test (10MWT) will be performed on a flat. The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective motor control in the lower extremity (hip, knee, ankle, subtalar, and toe joints). To evaluate trunk control, the Trunk Control Measurement Scale (TCMS) will be applied in a sitting position. For balance assessment, the Pediatric Balance Scale will be used to reflect activities of daily living. To assess functional independence, the Pediatric Functional Independence Measure (WeeFIM) will be applied. The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity.
Detailed description
Children aged between 6-18 years old, diagnosed with cerebral palsy and meeting the inclusion criteria, will be included in this study. The study will be conducted at the Özel Özgün Kardelen Special Education and Rehabilitation Center, affiliated with the Ministry of National Education in Antalya. All children and their parents who agree to participate in the study will be informed about the study and will be required to sign an "Informed Consent Form" indicating their voluntary participation.
To evaluate gait, the 3-Meter Backward Walking Test (3MBWT) and the 10-Meter Walk Test (10MWT) will be performed on a flat, obstacle-free track measuring 3 meters and 10 meters in length. The Selective Control Assessment of the Lower Extremity (SCALE) will be used to assess selective motor control in the lower extremity (hip, knee, ankle, subtalar, and toe joints). To evaluate trunk control, the Trunk Control Measurement Scale (TCMS) will be applied in a sitting position.
For balance assessment, the Pediatric Balance Scale, consisting of 14 items with increasing difficulty from a sitting position to standing on one leg, will be used to reflect activities of daily living. To assess functional independence, the Pediatric Functional Independence Measure (WeeFIM), which includes 6 sections and 18 items, will be applied. The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity.
Each child will be assessed only once. Statistical analyses for the study will be conducted using the Statistical Package for Social Sciences (SPSS) Version 21.0 (SPSS Inc., Chicago, IL, USA). Data distribution will be examined using the Shapiro-Wilk Test. Variables with normal distribution will be presented as mean ± standard deviation, while non-normally distributed variables will be presented as median (IQR). Categorical variables will be expressed as frequency and percentage (%). The correlation between the assessment results in the cases will be determined based on the normality of the distribution. The statistical error level will be set at p<0.05.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Cerebral Palsy | – | Other: Assessment |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who apply for rehabilitation in Special Education and Rehabilitation Centers affiliated to the Ministry of National Education in the city of Antalya will be included in the study.
Key inclusion criteria (7 listed)
- To be diagnosed with cerebral palsy by a specialist physician
- Gross Motor Function Classification System (GMFCS) level I or II
- Children with lower extremity muscles level ≤ 2 according to the Modified Ashworth Scale (MAS)
- Ability to follow verbal commands
- Modified Ashworth Scale (MAS) Level ≤2
Key exclusion criteria (2 listed)
- Having had Botox (Botulinum toxin) or a surgical operation in the last 6 months
- Having contractures in the ankle and knee joints that affect walking
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 |
|---|---|---|
| Assessment3 meter backward walk test (3MBWT), 10 meter walk test (10MWT), Selective Control Assessment of the Lower Extremities (SCALE), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Functional Independence Measure for Children (WeeFIM), Modified Ashworth Scale (MAS) | Other | Children With Cerebral Palsy |
Primary outcome
3 meter backward walk test (3MBWT)
Time frame: First day
The 3-Meter Backward Walk Test (3MBWT) measures the time it takes for a person to walk 3 meters backward. This test assesses balance, coordination, and leg strength, making it especially useful for individuals at risk of falling or those with neurological issues. During the test, the participant is timed while walking backward over a flat 3-meter distance. Completing the distance quickly and safely indicates good balance and backward walking ability, while taking longer may suggest potential issues with balance or motor control. This simple yet effective test is used in clinical settings to evaluate functional mobility and monitor progress over time.
10 meter walk test (10MWT)
Time frame: First day
The 10-Meter Walk Test (10MWT) measures the time it takes for a person to walk a distance of 10 meters at their comfortable walking pace. This test is widely used to assess walking speed, gait, and functional mobility, and it can be particularly beneficial for individuals with mobility impairments, including those with neurological conditions or musculoskeletal issues. During the test, the participant is timed while walking the 10-meter distance, with the time recorded starting when the participant's foot crosses the starting line and stopping when they cross the finish line. A shorter completion time indicates better walking speed and mobility, while longer times may suggest difficulties in gait or increased risk of falls. The 10MWT is a straightforward and effective tool used in clinical settings to evaluate functional mobility and track changes over time.
5 secondary outcomes
Selective Control Assessment of the Lower Extremities (SCALE)
Time frame: First day
Trunk Control Measurement Scale (TCMS)
Time frame: First day
Pediatric Balance Scale (PBS)
Time frame: First day
Functional Independence Measure for Children (WeeFIM)
Time frame: First day
Modified Ashworth Scale (MAS)
Time frame: First day
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 8 Nov 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.
Ebru Keklikci, Res. Assist. principal investigator
Alanya Alaaddin Keykubat 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 Balance, run by Alanya Alaaddin Keykubat 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 2 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 8 Nov 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?
3 meter backward walk test (3MBWT) (time frame: First day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.