An observational study in Cerebral Palsy, Balance and Gait Disorders in Children, sponsored by Alanya Alaaddin Keykubat University. Completed at 1 site in Turkey. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Alanya Alaaddin Keykubat University · Observational
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.
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.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 199 observational studies indexed under Paralysis.
Browse Paralysis studies →Alanya Alaaddin Keykubat University is the lead sponsor of 44 studies on the registry; 15 are open to participants now.
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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.
Exclusion Criteria:
Other: Assessment
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)
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.
Time frame: 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.
Time frame: First day
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First day
Plan to share: No
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Alanya Alaaddin Keykubat University