NCT04231227

Brief Summary

Selective motor control (SMC) impairment in children with cerebral palsy (CP) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. The research was designed to investigate the validity and the reliability of the Turkish version of the Test of Arm Selective Control (TASC) (which is improved to evaluate SMC in children with spastic CP) and in order to provide more understanding of the relationship between SMC and upper extremity and gross motor functions. The study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with CP whose ages are 4 to 18 years and Gross Motor Function Classification System (GMFCS) level changes from 1 to 4, and their parents. In order to evaluate the gross motor function of children, GMFCS and the ability to hold objects with their hands in daily activities were evaluated with Manual Ability Classification System (MACS). ABILHAND-Kids scale was applied to evaluate upper extremity performance. TASC scale was used to evaluate the upper extremity SMC of children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

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

July 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 10, 2020

Last Update Submit

January 13, 2020

Conditions

Keywords

cerebral palsyselective motor controlupper limbupper limb functionsgross motor functions

Outcome Measures

Primary Outcomes (4)

  • Test of Arm Selective Control

    an upper limb selective motor control evaluation tool.

    from July to September 2018

  • Abilhand- Kids Questionnaire

    to assess a child's unimanual and bimanual upper limb activities

    from July to September 2018

  • Manual Ability Classification System

    to assess manual abilities of children

    from July to September 2018

  • Gross Motor Function Classification System

    To assess gross motor functions of children

    from July to September 2018

Eligibility Criteria

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

Children in Special Education Centers

You may qualify if:

  • having a diagnosis of spastic CP
  • being able to understand the commands required for the test,
  • being between the ages of 3-18,
  • being GMFCS level I to IV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc. Student

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 18, 2020

Study Start

July 1, 2018

Primary Completion

September 30, 2018

Study Completion

June 15, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations