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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03179124
Other study ID # 214
Secondary ID
Status Completed
Phase N/A
First received June 6, 2017
Last updated June 6, 2017
Start date June 20, 2016
Est. completion date May 20, 2017

Study information

Verified date June 2017
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Children with cerebral palsy (CP) have postural control problems due to the lack of motor and sensory development. Trunk control which has an important role in ensuring postural control, is the basis for sitting, mobility, development of the upper extremity, pulmonary function and activities of daily living. Poor postural control restricts upper extremity functions which also affects the quality of movements. For this reason, it is important to assess the relationship between trunk control and upper extremity functions. This study is planned to investigate the effect of balance and trunk control on upper extremity functions in children with CP.


Description:

30 hemiparetic and 32 diparetic CP, in total 62 children, aged between 5-12 years, were included in this study. Trunk Control Measurement Scale (TCMS) was used to assess trunk control, Pediatric Balance Scale (PBS) was used to assess balance, and Quality of Upper Extremity Skills Test was used to assess upper extremity functions (QUEST).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 20, 2017
Est. primary completion date April 20, 2017
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility Inclusion Criteria:

- spastic hemiparetic and / or diparetic CP

- co-operative enough to understand test directives

- between 5 and 12 years of age

- Having spasticity of 0-2 according to the modified wax and / or modified Ashworth Scale (MAS)

- GMFCS I, II and III

Exclusion Criteria:

Have had previous orthopedic surgery to the upper extremity

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Upper Extremity Skills Test QUEST is a reliable tool for children with CP aged 2-12 years.The QUEST groups upper limb movement into four domains. Each domain focuses on areas of difficulty typically seen in children with spastic cerebral palsy: (a) Dissociated Movements, (ability to voluntarily isolate movement at the shoulder, elbow, wrist and fingers); (b) Grasps (which also rates sitting postures during grasps of 1 inch cube, cereal, pencil or crayon); (c) Weight Bearing (ability to lean on the arms in prone or 4-point kneeling, sitting and while reaching); and (d) Protective Extension (using the arms to stop oneself from falling forward, backward and to the side). In addition to the four domains of movement the QUEST also has three scales: Hand Function, Spasticity and Co-operativeness. 30 minutes
Secondary Pediatric Balance Scale The PBS measure can be performed without specialized equipment and is quickly and easily administered. The PBS has been used to measure the balance functions for school-age children with mild-to-moderate motor impairments 20 minutes
Secondary Trunk Control Measurement Scale This scale consists of 15 items measuring two main components of trunk control: (a) a stable base of support (static sitting balance), and (b) an actively moving body segment (dynamic sitting balance). The subscale static sitting balance (items 1-5) evaluates the ability of the child to maintain a stable trunk posture during movements of upper and lower limbs. The section dynamic sitting balance is further divided into two subscales: selective movement control and dynamic reaching. The subscale selective movement control (items 6-12) measures selective trunk movements in the sagittal (flexion/extension), frontal (lateral flexion) and transverse (rotation) plane within the base of support. The subscale dynamic reaching (items 13-15) evaluates the performance of three reaching tasks, requiring active trunk movements beyond the base of support 20 minutes
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