- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409730
Photographic Posture Analysis in Children With Cerebral Palsy
May 27, 2020 updated by: Nilay Comuk Balci, Baskent University
Reliability of Photographic Posture Analysis in Children With Cerebral Palsy and Its Relationship With Trunk Control and Motor Functions
Cerebral palsy (CP), which is the largest group of patients among pediatric neuromuscular diseases, is a non-progressive permanent disorder that affects muscle control, movement, posture and balance.
The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.Children with CP were included in the study according to the following criteria; aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS.
Postural evaluation was done using the photographic method.
Trunk control was evaluated with Trunk Control Measurement Scale,Motor performance of children was evaluated with Gross Motor Function Measure-88.
ICC values for photographic posture analysis was found to be highly reliable.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sitting position is of great importance in the development of upper extremity functions, orthogonal functional skills, personal care, cognitive, perceptual and social skills in children with cerebral palsy and these kids spend most of their time in a sitting position.There are goniometer, inclinometer, flexicurve, spinal mouse, and modified head posture spinal curvature ınstrument tools for posture analysis in the sitting position.However, none of these measurement tools have been validated for validity and reliability studies of head and trunk posture measurement in the sitting position in children with CP.
Methods such as magnetic resonance (MR) and x-ray used in posture evaluation provide clear images of reference points and are the gold standard in the literature.
However, they are not preferred much because they are expensive and contain radiation.Photographic posture analysis can be considered as a measurement method such as posture analysis methods using the gravity line.
It is a digital, more objective measurement method that measures linear distances and angles using anatomical reference points using specially designed software.
Clinical use of photographic posture analysis is recommended in the literature, as it is an accurate and objective method, preventing radiation exposure.The purpose of this study; to evaluate the reliability of photographic posture analysis in the sitting position in children with CP and to examine the relationship between the results of photographic posture analysis with the motor performances and trunk control of children with CP.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
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
-
-
Etimesgut
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Ankara, Etimesgut, Turkey, 06790
- Baskent University
-
-
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
Description
Inclusion Criteria:
- Aged 5-12 years,
- Diagnosed as spastic diplegia or hemiplegia,
- Having a level of "I, II, III" according to GMFCS
Exclusion Criteria:
- Children who could not cooperate,
- Have undergone spinal surgery, had botulinum toxin (BoNT) and surgical treatment in the last 6 months
- Had another neurodevelopmental or congenital disease other than CP
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
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children with Cerebral Palsy
Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS
|
Postural evaluation was done using the photographic method.
All measurements were made by two researchers experienced in postural analysis evaluation.
Canon camera and national geographic tripod with double spirit level were used for evaluation.
The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects.
Spirit levels have been adjusted so that the tripod is completely flat on the ground.
The tripod was taped to the floor to maintain the same distance between the camera and the participants.
Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Photographic Posture Analysis
Time Frame: 45-60 minutes
|
Postural evaluation was done using the photographic method.
All measurements were made by two researchers experienced in postural analysis evaluation.
Canon camera and national geographic tripod with double spirit level were used for evaluation Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers
|
45-60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Control Measurement Scale (TCMS)
Time Frame: 30-40 minutes
|
Trunk control was evaluated with Trunk Control Measurement Scale is a scale that measures the static and dynamic sitting balance in children with CP.
It consists of 15 items in total, 1-5 items measure Static Sitting Balance, 6-15 items measure dynamic sitting balance.
Static sitting balance assesses the ability of children to maintain the trunk posture as they move their upper and lower limbs in the sitting posture.
Dynamic sitting balance is divided into two sub-scales; selective motion control scale and dynamic reach scale.
The maximum score that can be obtained from the test is 58.
Higher scores perform better.
|
30-40 minutes
|
|
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: 30-45 minutes
|
GMFM-88 is a standardized observational test designed to measure the motor development levels of children with SP and their changes over time.
It consists of five main headings and 88 items: lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping.
17 of the 88 items are on the lying and rolling part, 20 on the sitting part, 14 on the crawling and kneeling part, 13 on the standing part, and 24 on the walking, running, and jumping part.
Likert scale is used in scoring.
The child gets 0 points if he / she cannot start the movement, 1 if he / she can start the movement independently, 2 if he / she can partially complete the movement, and 3 if he / she can complete the movement independently.
A 5-year-old child with normal development is expected to score full of 88 items.
The GMFM-88 was administered to the children by therapists trained in its use and tested to ensure an adequate level of competence by using a criterion test videotape
|
30-45 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nilay Çömük Balcı, Pt,PhD, Baskent University
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 1, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
May 22, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
June 1, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA19/126
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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