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Photographic Posture Analysis in Children With Cerebral Palsy

Primary Purpose

Posture Disorders in Children, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Photographic Posture Analysis
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Posture Disorders in Children focused on measuring trunk, posture analysis, cerebral palsy, performance

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with Cerebral Palsy

Arm Description

Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS

Outcomes

Primary Outcome Measures

Photographic Posture Analysis
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

Secondary Outcome Measures

Trunk Control Measurement Scale (TCMS)
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.
Gross Motor Function Measure-88 (GMFM-88)
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

Full Information

First Posted
May 22, 2020
Last Updated
May 27, 2020
Sponsor
Baskent University
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1. Study Identification

Unique Protocol Identification Number
NCT04409730
Brief Title
Photographic Posture Analysis in Children With Cerebral Palsy
Official Title
Reliability of Photographic Posture Analysis in Children With Cerebral Palsy and Its Relationship With Trunk Control and Motor Functions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posture Disorders in Children, Cerebral Palsy
Keywords
trunk, posture analysis, cerebral palsy, performance

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with Cerebral Palsy
Arm Type
Experimental
Arm Description
Aged 5-12 years, diagnosed as spastic diplegia or hemiplegia , having a level of "I, II, III" according to GMFCS
Intervention Type
Other
Intervention Name(s)
Photographic Posture Analysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Photographic Posture Analysis
Description
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
Time Frame
45-60 minutes
Secondary Outcome Measure Information:
Title
Trunk Control Measurement Scale (TCMS)
Description
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.
Time Frame
30-40 minutes
Title
Gross Motor Function Measure-88 (GMFM-88)
Description
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
Time Frame
30-45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay Çömük Balcı, Pt,PhD
Organizational Affiliation
Baskent University
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University
City
Ankara
State/Province
Etimesgut
ZIP/Postal Code
06790
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Photographic Posture Analysis in Children With Cerebral Palsy

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