NCT03504787

Brief Summary

The aim of the study was to determine upper extremity selective motor control (SMC) in Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship between upper extremity SMC and upper extremity functions in unilateral CP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

9 months

First QC Date

April 10, 2018

Last Update Submit

April 19, 2018

Conditions

Keywords

cerebral palsyupper extremityselective motor control

Outcome Measures

Primary Outcomes (1)

  • Selective Control of the Upper Extremity Scale (SCUES)

    The SCUES evaluate for movement at each joint level: the presence of mirror movements, movement of additional joints the target or index joint, presence of trunk movement, dynamic motion less than passive ROM. Upper extremity joint levels and motions examined include the shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers/thumb (grasp/release). A video camera is placed in front of a participant sitting on a table. The examiner demonstrate the desired motion to the participant, then passively moves the participant's joint in the desired planes. The participant is then asked to perform the same motion. This activity is graded by the examiner from the videotape. Evaluation lasts less than 15 minutes. 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 (2)

  • Jebsen Taylor Hand Function Test (JTT)

    10 minutes

  • Quality of Upper Extremity Skill Test (QUEST)

    20 minutes

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with unilateral cerebral palsy.

You may qualify if:

  • diagnosis of unilateral spastic CP,
  • age between 5 and 18 years,
  • ability to follow simple instructions.

You may not qualify if:

  • significant ataxia or dystonia
  • orthopedic intervention or botulinum toxin injection to the upper extremities in the last 6 months
  • orthopedic problems or medical conditions that prevented children from participating in the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazı University

Ankara, 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

    Gazi University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 20, 2018

Study Start

April 25, 2017

Primary Completion

January 25, 2018

Study Completion

March 25, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations