Clinical trial NCT04668820: 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
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Abnormality
Pediatric
Keywords: telemedicine
pandemic
video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
pediatric examination
musculoskeletal examination
reliability
acceptability
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinic
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
timeFrame: Day 0
measure: real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
timeFrame: Day 1
Secondary outcomes:
measure: Acceptability of V-pGALS examination to the child in terms of the duration
timeFrame: Day 1
measure: Acceptability of V-pGALS examination to the child in terms of the additional discomfort caused
timeFrame: Day 1
measure: Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the duration
timeFrame: Day 1
measure: Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the additional discomfort caused
timeFrame: Day 1
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
name: Evrim Karadag-Saygı, Prof
role: STUDY_CHAIR
affiliation: Koc University School of Medicine Department of Physical Medicine and Rehabilitation
name: Esra Giray, assoc. prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Koc University School of Medicine Department of Physical Medicine and Rehabilitation
name: Özden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
name: Ozge Kenis-Coskun, assoc. prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.