- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179124
Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
June 6, 2017 updated by: Ayse Simsek, Gazi University
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.
Study Overview
Status
Completed
Conditions
Detailed 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).
Study Type
Observational
Enrollment (Actual)
62
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cerebral palsy (CP) describes a group of permanent disorders in movement and posture that limit activity and participation and are attributed to non-progressive disturbances in the developing fetal or infant brain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Hemiparetic cerebral palsy
Unilateral paresis in which upper extremities are more severely affected than lower extremities.
|
Diparetic cerebral palsy
Lower extremities were more affected than upper extremities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Upper Extremity Skills Test
Time Frame: 30 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Balance Scale
Time Frame: 20 minutes
|
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
|
Trunk Control Measurement Scale
Time Frame: 20 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2016
Primary Completion (Actual)
April 20, 2017
Study Completion (Actual)
May 20, 2017
Study Registration Dates
First Submitted
June 6, 2017
First Submitted That Met QC Criteria
June 6, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
June 7, 2017
Last Update Submitted That Met QC Criteria
June 6, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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