Construct Validity and Reliability SCALE

Cerebral Palsy Clinical Trial

Official title:

Construct Validity and Reliability of the Selective Control Assessment of the Lower Extremity in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951441
• Other study ID #: selectivemotorcontrol
• Status: Recruiting
• Start date: October 9, 2017
• Est. completion date: July 22, 2019

Study information

• Verified date: May 2018
• Source: Hacettepe University
• Contact: Merve Tunçdemir
• Phone: 00903123051576
• Email: merve.kd[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control Assessment of the Lower Extremity ( SCALE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 22, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• diagnosis of spastic cerebral palsy,

• age between 4 and 18 years,

• ability to follow simple instructions.

• ability to walk (GMFCS levels I-IV),

Exclusion Criteria:

• unstable situation regarding their tonus-regulating medications

• orthopedic intervention or surgical correction within the last year,

• botulinum toxin injection within the last 6 months

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Sihhiye

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Selective Control Assessment of the Lower Extremity	SCALE examines SVMC in children with spastic CP. The SCALE tool assesses hip, knee, ankle, subtalar, and toe joints bilaterally.The SCALE tool assigns each joint a score from 0 to 2 points: 2 points, normal; 1 point, impaired; and 0 points, unable. The SCALE score is the sum of scoresfor each joint and assumes a 10 point maximum per limb.	15 minutes
Secondary	Gross Motor Function Classification System (GMFCS)	The GMFCS describes gross motor function in children with CP. It focuses on self-initiated movements, in particular sitting and walking. It is an age-related five-level system in which level I represents the least limitation and level V the most.	2 minutes
Secondary	Gross Motor Function Measurement (GMFM)	Gross Motor Function Measurement evaluates motor functions in children with Cerebral Palsy. There is 88 items under 5 subdimensions (lying and rolling, sitting, crawling and kneeling, standing, walking-running-jumping. GMFM has a 4-point scoring system for each item. The higher the child gets, the more successful the child is in gross motor functions.	15 minutes
Secondary	Modified Ashworth Scale (MAS)	Tone of lower extremity muscles will be assessed with Modified Ashworth Scale. The spasticity of each muscle ranged between 0 to 5. 0 means no increase in muscle tonus while 5 means that the joint is rigid due to the increase in excess tonus.	5 minutes
Secondary	The Physicians' Rating Scale (PRS)	The Physicians' Rating Scale is an observational tool that has been used to evaluate gait. PRS is assesses gait in the sagittal plane.	5 minutes