NCT03600597

Brief Summary

The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control of the Upper Extremity Scale (SCUES).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 17, 2018

Last Update Submit

July 25, 2018

Conditions

Cerebral PalsyUpper Extremity Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Selective Control of the Extremity Scale

    SCUES administration required patients to perform specific isolated movement patterns at the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/ thumb (grasp/release). Presence of mirror movements, movement of additional joints and motion less than available ROM are graded for movement at each joint level. Motion at each of the five joint levels is graded on a four-point scale: no SMC, moderately diminished SMC, mildly diminished SMC, and normal SMC.

    10 minutes

Secondary Outcomes (1)

  • Jebsen Taylor Hand Function Test

    20 minutes

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with Unilateral Cerebral Play

You may qualify if:

  • Ages between 3-18 years
  • Diagnosed as Cerebral Palsy (Hemiplegia)

You may not qualify if:

  • Participants with an unstable situation regarding their tonus-regulating medications
  • Participants had a botulinum toxin injection within the last 6 months, or any surgical correction within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Yeni̇mahalle, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bulent Elbasan

    Study chair

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

April 10, 2017

Primary Completion

March 10, 2018

Study Completion

May 10, 2018

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

TU(1)