Determination of the Optimal Cut Off Value of the Modified Ashworth Scale in the Evaluation of Gait Performance and Functional Mobility in Individuals With Cerebral Palsy

NCT06826131 | Completed

• 1 other identifier: Ashworth- SP
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The spastic type, which is the most common type of CP, constitutes approximately 75% of individuals. The most prominent physical examination finding in patients with CP is marked tonus changes. Increased tonus and involuntary movement patterns are frequently observed clinically. Today, the Modified Ashworth Scale is mostly used in the evaluation of spasticity in individuals. Ashworth scale was defined in 1964 and modified in 1987. This scale was developed to assess muscle tone. Resistance to passive movement is evaluated and scored between 0-4.

Conditions

Cerebral Palsy (CP); Walking Performance; Functional Mobility

Keywords

cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Optimal cut off value of modified ashworth scale in individuals with CP

  To determine the optimal cut off value of the modified ashworth scale in the evaluation of gait performance and functional mobility in individuals with CP aged 6-15 years. The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.

  1 days

Study Arms (1)

Cerebral Palsy

Individuals with Cerebral Palsy between the ages of 6-15 with gMFSS:1-2

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

It was observed that the effect size obtained in the reference study was strong (d=1.28). As a result of the power analysis performed considering that an effect size at this level could also be obtained; it was calculated that 95% power could be obtained at 95% confidence level when at least 25 people were included in the study (Freire et al, 2023).

You may qualify if:

• GMFSS:1-2,
• Have the appropriate cognitive level to adapt to the tests to be performed in the study,
• Individuals between the ages of 6-15 who agreed to participate in the study were included.

You may not qualify if:

• Bone and/or soft tissue surgery on the lower extremities within the last 1 year who had the operation,
• Extensive serious skin injuries, skin infection,
• Lower extremity MAS score \> 2,
• Mental retardation,
• Individuals who had botulinum toxin applied to their lower extremities within the last 1 year were excluded.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Kayseri City Hospital, Physical Medicine and Rehabilitation Clinic

Kayseri, 38080, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants' biospecimens and DNA will not be used.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: February 8, 2025
• Primary Completion: April 10, 2025
• Study Completion: May 10, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-02

Locations

TU (1)