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Completed

NCT Number: NCT04668820

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

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.

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Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Day 0

    Face to face examination

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

    Time frame: Day 1

    Video real-time examination via zoom application

Secondary outcomes

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

    Time frame: Day 1

    visual analog scale with smiley faces (0-10, 0 for full acceptability)

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

    Time frame: Day 1

    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)

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

    Time frame: Day 1

    visual analog scale with smiley faces (0-10, 0 for full acceptability)

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

    Time frame: Day 1

    visual analog scale with smiley faces (0-10, 0 for full acceptability)

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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