Construct Validity and Reliability SCALE

• Conditions: Cerebral Palsy

• Registration Number: NCT03951441
• Lead Sponsor: Hacettepe University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-09
• Status Verified: 2018-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-15
• Last Update Posted: 2019-05-15
• Primary Completion: 2019-06-20
• Study Completion: 2019-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Selective Control Assessment of the Lower Extremity	15 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Gross Motor Function Measurement (GMFM)	15 minutes	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.
Modified Ashworth Scale (MAS)	5 minutes	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.
Gross Motor Function Classification System (GMFCS)	2 minutes	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.
The Physicians' Rating Scale (PRS)	5 minutes	The Physicians' Rating Scale is an observational tool that has been used to evaluate gait. PRS is assesses gait in the sagittal plane.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Sıhhiye, Turkey