NCT03951441

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

May 14, 2019

Last Update Submit

May 14, 2019

Conditions

Cerebral Palsy

Keywords

lower limb

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Gross Motor Function Classification System (GMFCS)

    2 minutes

  • Gross Motor Function Measurement (GMFM)

    15 minutes

  • Modified Ashworth Scale (MAS)

    5 minutes

  • The Physicians' Rating Scale (PRS)

    5 minutes

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with Spastic Cerebral Palsy

You may qualify if:

  • diagnosis of spastic cerebral palsy,
  • age between 4 and 18 years,
  • ability to follow simple instructions.
  • ability to walk (GMFCS levels I-IV),

You may not qualify if:

  • unstable situation regarding their tonus-regulating medications
  • orthopedic intervention or surgical correction within the last year,
  • botulinum toxin injection within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Merve Tunçdemir

CONTACT

00903123051576merve.kd@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 15, 2019

Study Start

October 9, 2017

Primary Completion

June 20, 2019

Study Completion

July 22, 2019

Last Updated

May 15, 2019

Record last verified: 2018-05

Locations

TU(1)