- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05749809
The Relationship Between Lower Extremity Selective Motor Control and Gait in Children With Cerebral Palsy
September 11, 2023 updated by: Erkan Erol, Tokat Gaziosmanpasa University
The aim of this study is to examine the relationship between lower extremity selectivity and gait in children with cerebral palsy.
32 volunteer children with CP between the ages of 5-20 will participate in the study.
The Selective Control Assessment of the Lower Extremity (SCALE) questionnaire will be used to assess lower extremity selectivity, and the Edinburgh observational gait scale will be used to assess gait.
Both assessments are observational.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokat, Turkey, 60250
- Recruiting
- Faculty of Health Sciences, Tokat Gaziosmanpaşa University
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Contact:
- Erkan Erol, PhD
- Phone Number: 05547920118
- Email: erkanerol@gmail.com
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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 20 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Cerebral palsy
Description
Inclusion Criteria:
- Between the ages of 5-20
- Diagnosed with CP
Exclusion Criteria:
- Medical complications that limit participation in assessments (for example, severe visual impairment)
- Lower extremity surgery or botox surgery in the last 6 months
- Mental problems that cannot understand the commands given
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edinburgh Visual Gait Score
Time Frame: Baseline
|
It consists of 17 items scored separately for the right and left lower extremities.
Assessments include 6 anatomical levels: trunk, pelvis, hip, knee, ankle, and foot.
These anatomical levels are evaluated in the sagittal, coronal and transverse planes.
A 3-point ordinal scale is used for scoring.
In scoring, a value of 0 indicates normal, a value of 1 indicates moderate deviation from normal, and a value of 2 indicates significant deviation from normal.
The scores obtained by watching the camera recordings for each lower extremity are summed and a single score is obtained.
|
Baseline
|
Selective Control Assessment of the Lower Extremity (SCALE)
Time Frame: Baseline
|
Evaluates the selective motor control of the lower extremities.
It evaluates hip, knee, ankle, subtalar and finger joints bilaterally.
Voluntary flexion and extension movements are observed to assess selective voluntary motor control at each joint.
Except for the hip joint, which is tested in the side-lying position to allow adequate joint movement, the evaluation of other joints is made in the sitting position.
|
Baseline
|
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)
March 30, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
July 30, 2024
Study Registration Dates
First Submitted
February 19, 2023
First Submitted That Met QC Criteria
February 19, 2023
First Posted (Actual)
March 1, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaU_Erol_05
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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