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

NCT04668820 | Completed

• 1 other identifier: 09.2020.1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Abnormality; Pediatric

Keywords

telemedicine; pandemic; video Pediatric Gait, Arms, Legs and Spine (V-pGALS); pediatric examination; musculoskeletal examination; reliability; acceptability

Outcome Measures

Primary Outcomes (2)

• Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

  Face to face examination

  Day 0

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

  Video real-time examination via zoom application

  Day 1

Secondary Outcomes (4)

• Acceptability of V-pGALS examination to the child in terms of the duration

  Day 1

• Acceptability of V-pGALS examination to the child in terms of the additional discomfort caused

  Day 1

• Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the duration

  Day 1

• Acceptability of V-pGALS examination to the parent who will be present during examination in terms of the additional discomfort caused

  Day 1

Study Arms (1)

Children who admit to Pediatric Rehabilitation outpatient clinic

EXPERIMENTAL

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)

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

Interventions

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

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.

Children who admit to Pediatric Rehabilitation outpatient clinic

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28926470 RESULT

• 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.

  PMID: 2753146 RESULT

• 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.

  PMID: 33129319 RESULT

• 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.

  PMID: 35319535 DERIVED

MeSH Terms

Conditions

Musculoskeletal Abnormalities; Rhabdomyosarcoma, Alveolar

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Evrim Karadag-Saygı, Prof

  Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

  STUDY CHAIR

• Esra Giray, assoc. prof

  Koc University School of Medicine Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Özden Ozyemisci Taskiran, Prof

  Koc University School of Medicine Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Ozge Kenis-Coskun, assoc. prof

  Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinic

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 16, 2020
• Study Start: August 20, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: October 14, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)