The Relationship of Forward and Backward Walking with SMC, Trunk Control and Balance in Children with Cerebral Palsy

NCT ID: NCT05962749

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2024-03-15

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.

Conditions

Cerebral Palsy; Balance; Gait Disorders in Children

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Children With Cerebral Palsy

Assessment

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alanya Alaaddin Keykubat University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Keklikci

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Keklikci, Res. Assist.

Role: PRINCIPAL_INVESTIGATOR

Alanya Alaaddin Keykubat University

Locations

Alanya Alaaddin Keykubat University

Antalya, Alanya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-743

Identifier Type: -

Identifier Source: org_study_id