Clinical trial NCT05962749: The Relationship of Forward and Backward Walking with SMC, Trunk Control and Balance in Children with Cerebral Palsy
Official title: The Relationship of Forward and Backward Walking with Selective Motor Control, Trunk Control and Balance in Children with Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Balance
Gait Disorders in Children
Keywords: Cerebral Palsy
Backward Walking
Selective Motor Control
Trunk Control
Balance
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 3 meter backward walk test (3MBWT)
timeFrame: First day
measure: 10 meter walk test (10MWT)
timeFrame: First day
Secondary outcomes:
measure: Selective Control Assessment of the Lower Extremities (SCALE)
timeFrame: First day
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: First day
measure: Pediatric Balance Scale (PBS)
timeFrame: First day
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: First day
measure: Modified Ashworth Scale (MAS)
timeFrame: First day
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Alaaddin Keykubat University
state: Alanya
Study officials:
affiliation: Alanya Alaaddin Keykubat University
name: Ebru Keklikci, Res. Assist.
role: PRINCIPAL_INVESTIGATOR
References: