"Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy

NCT06343688 | Recruiting

• 1 other identifier: BAIBU-FTR-SAT-5
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

" Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval."

Conditions

Diplegic Cerebral Palsy

Keywords

cerebral palsy; Diplegia; Spastic; orthosis; balance

Outcome Measures

Primary Outcomes (4)

• Wii Balance Board

  The Wii Balance Board transmits vertical ground reaction forces from four corners of the device to the Wii system via Bluetooth when an individual stands on it. The Fizyosoft Balance System, developed by engineers and physiotherapists, will be used to assess static balance in participating children. Swing speeds measured using the Wii Balance Board, which establishes a Bluetooth connection with a computer, will be indexed. The dimensions of the Wii Balance Board are approximately 45 x 26.5 cm, with a weight capacity of approximately 150 kg. Children will be instructed to stand on the device with their feet parallel to each other and remain motionless for 15 seconds, with measurements taken with eyes open and closed. The coordinates of the individuals' center of pressure (COPx, COPy) will be recorded in centimeters (cm), while the performance value will be recorded as a percentage in the system.""A high deviation from the x and y coordinates indicates poor balance."

  day 1

• "The Gross Motor Function Measure-88 (D-E) (GMFM-88)

  To assess changes in lower extremity gross motor function in children with cerebral palsy, the D (Standing) and E (Walking/Running/Jumping) sections of the GMFM-88 test will be used. The D section consists of 12 questions ranging from 52 to 64, and the E section consists of 23 questions ranging from 65 to 88. A total of 35 questions will be evaluated""Low scores indicate poor gross motor function."

  day 1

• The Functional Reach Test

  The Functional Reach Test is a dynamic balance assessment method. It measures the maximum distance that can be reached forward and sideways while standing upright. The reached distance is calculated as the difference between the maximum distance reached while standing upright without lifting the heels from the ground and the maximum distance reached while maintaining hip flexion without lifting the heels from the ground. This method, commonly used in adults, is employed to evaluate the ability to maintain balance and stability. Studies have shown that this test, designed for adults, can also be applied to children.Low scores indicate poor balance.

  day 1

• "The Pediatric Berg Balance Scale (PBBS)

  The Pediatric Berg Balance Scale (PBBS) is a test consisting of 14 questions related to parameters such as standing up from sitting, standing, transfers, walking, turning, etc. Each question is scored from 0 to 4, and the time taken to perform the desired activity is recorded. At the end of the test, the total score obtained by the individual is calculated and recorded. Validity and reliability studies of this scale have been conducted for various neurological diseases such as Parkinson's disease, stroke, spinal cord injuries, etc., as well as for geriatrics.""Higher scores indicate better balance levels."

  day 1

Secondary Outcomes (4)

• "The Eating and Drinking Ability Classification System (EDACS)

  day 1

• "The Manual Abilities Classification System (MACS)

  day 1

• "The Gross Motor Function Classification System (GMFCS)

  day 1

• "The Communication Function Classification System (CFCS)

  day 1

Study Arms (1)

Case Group

"The Gross Motor Function Classification System (GMFCS) will be used to classify children's gross motor levels, the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills. Additionally, the Gross Motor Function Measure (GMFM-88) items D and E will be used to assess motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be evaluated in two different ways: with and without DAFO."

Other: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO"

Interventions

"Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO" OTHER

"Measurements will be conducted with the child's custom-made DAFO (Dynamic Ankle-Foot Orthosis) and barefoot."

Case Group

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with spastic diplegic cerebral palsy who are independently walking and aged between 4 and 15 years.

You may qualify if:

• Diagnosed with Spastic Diplegic type of cerebral palsy
• Age between 4 and 15 years
• Using bilateral Dynamic Ankle-Foot Orthosis (DAFO)
• Communication Function Classification System (CFCS) level between 1 and 2
• Gross Motor Function Classification System (GMFCS) level between 1 and 2
• Willingness to participate in the study

You may not qualify if:

• Having experienced lower extremity fractures or muscle-tendon and bone surgery in the past 6 months, or having undergone spinal or orthopedic surgery affecting the lower extremities
• Exposure to any pharmacological agent or intervention inhibiting spasticity in the past 6 months.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• özge karanlık

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda Ayaz Taş, Asst. prof.

CONTACT

5495458040; seda.ayaztas@ibu.edu.tr

Tamer Çankaya, Asst. prof.

CONTACT

5335519171; tamercankaya@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 3, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

TU (1)