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

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04668820
Collaborator
(none)
20
1
1
1.7
11.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinicChildren 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
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Aug 20, 2021
Actual Primary Completion Date :
Oct 12, 2021
Actual Study Completion Date :
Oct 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children who admit to Pediatric Rehabilitation outpatient clinic

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)
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.

Outcome Measures

Primary Outcome Measures

  1. Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS) [Day 0]

    Face to face examination

  2. real-time virtual video Pediatric Gait, Arms, Legs and Spine (V-pGALS) [Day 1]

    Video real-time examination via zoom application

Secondary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University School of Medicine Department of Physical Medicine and Rehabilitation Istanbul Turkey 34899

Sponsors and Collaborators

  • Marmara University

Investigators

  • Study Chair: Evrim Karadag-Saygı, Prof, Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT04668820
Other Study ID Numbers:
  • 09.2020.1
First Posted:
Dec 16, 2020
Last Update Posted:
Oct 14, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021