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Reliability and Acceptability of Real-time Virtual Video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

Primary Purpose

Musculoskeletal Abnormality, Pediatric

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Musculoskeletal Abnormality focused on measuring telemedicine, pandemic, video Pediatric Gait, Arms, Legs and Spine (V-pGALS), pediatric examination, musculoskeletal examination, reliability, acceptability

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation

Exclusion Criteria:

  • Non-ambulatory children
  • Children with poor cooperation
  • Being severe ill and unable to tolerate examination
  • Children and parents who do not give oral and written permission for study enrollment

Sites / Locations

  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children who admit to Pediatric Rehabilitation outpatient clinic

Arm Description

Children who admit to Pediatric Rehabilitation outpatient clinic of the Department of Physical Medicine and Rehabilitation will be evaluated by face to face and virtually by using zoom application via video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

Outcomes

Primary Outcome Measures

Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Face to face examination
real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Video real-time examination via zoom application

Secondary Outcome Measures

Acceptability of V-pGALS examination to the child in terms of the duration
visual analog scale with smiley faces (0-10, 0 for full acceptability)
Acceptability of V-pGALS examination to the child in terms of the additional discomfort caused
visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability)
Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the duration
visual analog scale with smiley faces (0-10, 0 for full acceptability)
Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the additional discomfort caused
visual analog scale with smiley faces (0-10, 0 for full acceptability)

Full Information

First Posted
December 9, 2020
Last Updated
October 13, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04668820
Brief Title
Reliability and Acceptability of Real-time Virtual Video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Official Title
Reliability and Acceptability of Real-time Virtual Video Pediatric Gait, Arms, Legs and Spine (V-pGALS) Assessment for Musculoskeletal Assessment of Children for Telemedicine Visits
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

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

5. Study Description

Brief Summary
The use of telemedicine in musculoskeletal assessment has been historically low. The current COVID 19 global pandemic has forced a paradigm shift with many centers rapidly adopting virtual visits to conduct care resulting in rapid expansion of use of telemedicine amongst practices. Mayoclinic has published The Telemedicine Musculoskeletal Examination for adults. Paediatric Musculoskeletal Matters (PMM) has put video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment sheet on their website. However, there is a lack of the acceptability and reliability of these tools. The aim of this study is to investigate acceptability and reliability of real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment for musculoskeletal assessment of children for telemedicine visits.
Detailed Description
The use of telemedicine in musculoskeletal assessment has been historically low. The current COVID 19 global pandemic has forced a paradigm shift with many centers rapidly adopting virtual visits to conduct care resulting in rapid expansion of the use of telemedicine amongst practices. Mayoclinic has published The Telemedicine Musculoskeletal Examination for adults. 'Paediatric Musculoskeletal Matters' (PMM- www.pmmonline.org, is a free, evidence-based, and peer-reviewed open e-resource for pediatric musculoskeletal (MSK) medicine targeting non-MSK specialists. They have also published video Pediatric Gait, Arms, Legs and Spine (V-pGALS), an assessment sheet for telemedicine visits on their webpage. However, there is a lack of the acceptability and reliability of these tools. The aim of this study is to investigate acceptability and reliability of real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) assessment for musculoskeletal assessment of children for telemedicine visits. For this purpose, children at between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation of Marmara University School of Medicine will be recruited to the study. They will be evaluated via V-pGALS face to face on the day of admission and the physiatrist will record the diagnosis if there is. Within 24 hours the child will be reevaluated via V-pGALS by using Zoom application virtually. The acceptability of V-pGALS examination to the child and parents in terms of the duration and additional discomfort caused was evaluated using visual analog scale with smiley faces (0-10, 0 for full acceptability).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Abnormality, Pediatric
Keywords
telemedicine, pandemic, video Pediatric Gait, Arms, Legs and Spine (V-pGALS), pediatric examination, musculoskeletal examination, reliability, acceptability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinic
Masking
None (Open Label)
Masking Description
Two phsyiatrist who will perform virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) and the physiatrist who will perform face to face examination will be blinded to each other
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children who admit to Pediatric Rehabilitation outpatient clinic
Arm Type
Experimental
Arm Description
Children who admit to Pediatric Rehabilitation outpatient clinic of the Department of Physical Medicine and Rehabilitation will be evaluated by face to face and virtually by using zoom application via video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Intervention Type
Diagnostic Test
Intervention Name(s)
video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Intervention Description
The Video-pGALS includes maneuvers from pediatric regional examination of the musculoskeletal system (pREMS) and derived from the pediatric gait arms legs spine examination assessment which is a validated simple basic musculoskeletal (MSK) examination for children. V-pGALS offers a structured approach to a cursory overview MSK exam with a focus on range of movement and symmetry. Utilizing the parent or caregiver to feel the joint in question for obvious warmth/ swelling or to palpate for point of maximal tenderness can add important information.
Primary Outcome Measure Information:
Title
Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Description
Face to face examination
Time Frame
Day 0
Title
real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Description
Video real-time examination via zoom application
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Acceptability of V-pGALS examination to the child in terms of the duration
Description
visual analog scale with smiley faces (0-10, 0 for full acceptability)
Time Frame
Day 1
Title
Acceptability of V-pGALS examination to the child in terms of the additional discomfort caused
Description
visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability). visual analog scale with smiley faces (0-10, 0 for full acceptability)
Time Frame
Day 1
Title
Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the duration
Description
visual analog scale with smiley faces (0-10, 0 for full acceptability)
Time Frame
Day 1
Title
Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the additional discomfort caused
Description
visual analog scale with smiley faces (0-10, 0 for full acceptability)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children between the ages of 7-18 who admitted the Pediatric Rehabilitation outpatient clinic of Department of Physical Medicine and Rehabilitation Exclusion Criteria: Non-ambulatory children Children with poor cooperation Being severe ill and unable to tolerate examination Children and parents who do not give oral and written permission for study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim Karadag-Saygı, Prof
Organizational Affiliation
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Esra Giray, assoc. prof
Organizational Affiliation
Koc University School of Medicine Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özden Ozyemisci Taskiran, Prof
Organizational Affiliation
Koc University School of Medicine Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ozge Kenis-Coskun, assoc. prof
Organizational Affiliation
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.
Citations:
PubMed Identifier
28926470
Citation
Batu ED, Kenis Coskun O, Sonmez HE, Karali D, Arslanoglu Aydin E, Bilginer Y, Karadag Saygi E, Ozen S. Acceptability and Practicality of the Turkish Translation of Pediatric Gait Arm Legs and Spine in Turkish Children. J Clin Rheumatol. 2017 Dec;23(8):421-424. doi: 10.1097/RHU.0000000000000586.
Results Reference
result
PubMed Identifier
2753146
Citation
Pelaez F, de Haro C. Translational inhibition by eIF-2-phospholipid complex in mammalian cell-free systems. FEBS Lett. 1989 Jul 3;250(2):523-8. doi: 10.1016/0014-5793(89)80789-6.
Results Reference
result
PubMed Identifier
33129319
Citation
Shenoi S, Hayward K, Curran ML, Kessler E, Mehta JJ, Riebschleger MP, Foster HE. Telemedicine in pediatric rheumatology: this is the time for the community to embrace a new way of clinical practice. Pediatr Rheumatol Online J. 2020 Oct 31;18(1):85. doi: 10.1186/s12969-020-00476-z.
Results Reference
result
PubMed Identifier
35319535
Citation
Giray E, Kenis-Coskun O, Karadag-Saygi E, Ozyemisci-Taskiran O. Interrater Reliability, Acceptability, and Practicality of Real-Time Video Pediatric Gait, Arms, Legs, and Spine for Musculoskeletal Assessment of Children During Telemedicine Visits. J Clin Rheumatol. 2022 Aug 1;28(5):235-239. doi: 10.1097/RHU.0000000000001840. Epub 2022 Mar 22.
Results Reference
derived

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Reliability and Acceptability of Real-time Virtual Video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

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