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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04231227
Other study ID # Upper Limb SMC in CP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date June 15, 2019

Study information

Verified date January 2020
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 15, 2019
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria: • Having undergone orthopedic surgery or Botulinum Toxin A (BTX-A) within the last 6 months

Study Design


Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test of Arm Selective Control an upper limb selective motor control evaluation tool. from July to September 2018
Primary Abilhand- Kids Questionnaire to assess a child's unimanual and bimanual upper limb activities from July to September 2018
Primary Manual Ability Classification System to assess manual abilities of children from July to September 2018
Primary Gross Motor Function Classification System To assess gross motor functions of children from July to September 2018
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