Construct Validity and Reliability SCALE

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

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).

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy

• Study Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

Study Locations

• Turkey
  • Sıhhiye
    • Ankara, Sıhhiye, Turkey, 06100
      • Recruiting
      • HACETTEPE UNIVERSİTY
      • Contact: Merve Tunçdemir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with Spastic Cerebral Palsy

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Anticipated): June 20, 2019
• Study Completion (Anticipated): July 22, 2019

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: lower limb
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: selectivemotorcontrol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No