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Musculoskeletal AbnormalityNCT04668820

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

A study testing video Pediatric Gait, Arms, Legs and Spine (V-pGALS) in people with Musculoskeletal Abnormality and Pediatric, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Musculoskeletal Abnormality, Pediatric
What is being tested?
video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Aug 2021to 12 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul, 34899

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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).

Being tested
video Pediatric Gait, Arms, Legs and Spine (V-pGALS)
Keywords
telemedicine, pandemic, video Pediatric Gait, Arms, Legs and Spine (V-pGALS), pediatric examination, musculoskeletal examination, reliability, acceptability
Medical subject headings
Musculoskeletal Abnormalities, Rhabdomyosarcoma, Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04668820
Study groupRoleWhat they receive
Children who admit to Pediatric Rehabilitation outpatient clinicExperimentalChildren 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)
Receives: Diagnostic Test: video Pediatric Gait, Arms, Legs and Spine (V-pGALS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Face to face examination

    Measured: Day 0

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

    Video real-time examination via zoom application

    Measured: Day 1

Secondary outcomes (4)

  1. 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)

    Measured: Day 1

  2. 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)

    Measured: Day 1

  3. 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)

    Measured: Day 1

  4. 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)

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start20 Aug 2021
  3. Primary completion12 Oct 2021
  4. Study completion12 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Children between the ages of 7-18 who admit pediatric rehabilitation outpatient clinic
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04668820
Sponsor's protocol ID
09.2020.1
Status last verified
Dec 2020
First submitted
9 Dec 2020
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.

Publications

  • 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.

    PubMed 28926470

  • 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.

    PubMed 2753146

  • 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.

    PubMed 33129319

  • 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.

    PubMed 35319535

Questions about this trial

What is this clinical trial studying?

A study testing video Pediatric Gait, Arms, Legs and Spine (V-pGALS) in people with Musculoskeletal Abnormality and Pediatric, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Face to face examination of video Pediatric Gait, Arms, Legs and Spine (V-pGALS) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04668820, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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