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

Pediatric Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668820
• Other study ID #: 09.2020.1
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: October 12, 2021

Study information

• Verified date: December 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Abnormalities
• Musculoskeletal Abnormality
• Pediatric

Intervention

Diagnostic Test:
• video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Batu ED, Kenis Coskun Ö, Sönmez HE, Karali D, Arslanoglu Aydin E, Bilginer Y, Karadag Saygi E, Özen 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 — View 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. — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS)	Face to face examination	Day 0
Primary	real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS)	Video real-time examination via zoom application	Day 1
Secondary	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)	Day 1
Secondary	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)	Day 1
Secondary	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)	Day 1
Secondary	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)	Day 1

External Links

•   video Pediatric Gait, Arms, Legs and Spine (V-pGALS)