NCT04685434

Brief Summary

The most commonly used performance tests to evaluate upper extremity function in children diagnosed with rheumatic disease are the 9-hole peg test and Jebsen Taylor hand function tests. Although these tests have advantages such as being able to be applied in a short time, providing objective data, being easily applicable in the clinical environment, and being cost-effective, these tests are non-specific performance tests. Fine motor skills specific to rheumatic diseases, planned for children; There is no test battery that examines the mobility and position of each segment of the upper extremity during a function in detail. The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based assessment approved for use in children with hemiplegic cerebral palsy. In addition to spontaneous functional movement, it also evaluates the dynamical position, grip, and release movements of the upper extremity segments. Approved with a total of 22 questions/tasks observed for children aged 3-18. While the evaluation takes about 15 minutes, it takes about 15-30 minutes for the participant to score after the evaluation. The test battery can be created with the materials found in the physiotherapy clinic and is therefore very practical in terms of cost. In addition, due to the video recording of the evaluation, it provides a detailed examination opportunity to the evaluator both during and after the evaluation. However, it is superior to other tests in terms of creating a patient archive due to video recording. This study aimed to introduce SHUEE to the literature as a new assessment tool to be used in pediatric rheumatic pathologies. It is planned to include 25 volunteer pediatric patients diagnosed with rheumatic diseases in the study. Intra-observer and inter-observer reliability of SHUEE in children with a rheumatic diagnosis will be evaluated. For validity, the Jebsen-Taylor Hand Function test and Childhood Health Assessment Questionnaire will be used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

December 12, 2020

Last Update Submit

August 30, 2021

Conditions

Keywords

rheumatic diseaseschildrenfunction

Outcome Measures

Primary Outcomes (3)

  • Shriners Hospital Upper Extremity Evaluation

    The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function. The outcome is the total score of the spontaneous functional analysis, dynamic positional analysis, and grasp/release analysis. Higher scores mean a better outcome.

    Baseline

  • Jebsen-Taylor Hand Function Test

    The Jebsen-Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). The outcome is the sum of time taken for each sub-test, which is rounded to the nearest second. Lower scores mean a better outcome. Except for the subtest titled writing, all subtest scores should be under 10 seconds at least.

    Baseline

  • Shriners Hospital Upper Extremity Evaluation

    The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function. The outcome is the total score of the spontaneous functional analysis, dynamic positional analysis, and grasp/release analysis. Higher scores mean a better outcome.

    after two weeks from baseline

Secondary Outcomes (1)

  • The Childhood Health Assessment Questionnaire

    Baseline

Study Arms (1)

pediatric patients diagnosed with rheumatic diseases.

The Shriners Hospital for Children Upper Extremity Evaluation, the Jebsen-Taylor Hand Function Test, and the Childhood Health Assessment Questionnaire will be administered in children with rheumatic diseases. The Shriners Hospital for Children Upper Extremity Evaluation will be administered two weeks after the first examination and the results will be compared.

Other: Shriners Hospital for Children Upper Extremity Evaluation

Interventions

The interventions are evaluating tools for the functional performance of the upper extremity.

Also known as: Jebsen-Taylor Hand Function Test, Childhood Health Assessment Questionnaire
pediatric patients diagnosed with rheumatic diseases.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

the patients who applied to the pediatric rheumatology clinic in the university hospital

You may qualify if:

  • To be in the 10-18 ages group (In order for the devices to comply with the minimum measurement criteria and to be able to cooperate with the study)
  • Being diagnosed with rheumatic diseases at least 6 months ago with only upper extremity affected
  • Unilateral upper extremity involvement

You may not qualify if:

  • Having an acute pathology that could affect walking
  • To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Davids JR, Peace LC, Wagner LV, Gidewall MA, Blackhurst DW, Roberson WM. Validation of the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) for children with hemiplegic cerebral palsy. J Bone Joint Surg Am. 2006 Feb;88(2):326-33. doi: 10.2106/JBJS.E.00298.

    PMID: 16452744BACKGROUND
  • Ozdogan H, Ruperto N, Kasapcopur O, Bakkaloglu A, Arisoy N, Ozen S, Ugurlu U, Unsal E, Melikoglu M; Paediatric Rheumatology International Trials Organisation. The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin Exp Rheumatol. 2001 Jul-Aug;19(4 Suppl 23):S158-62.

    PMID: 11510322BACKGROUND
  • Sigirtmac IC, Oksuz C. Investigation of reliability, validity, and cutoff value of the Jebsen-Taylor Hand Function Test. J Hand Ther. 2021 Jul-Sep;34(3):396-403. doi: 10.1016/j.jht.2020.01.004. Epub 2020 Mar 7.

    PMID: 32156578BACKGROUND

MeSH Terms

Conditions

Rheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD Student

Study Record Dates

First Submitted

December 12, 2020

First Posted

December 28, 2020

Study Start

November 4, 2020

Primary Completion

March 15, 2021

Study Completion

March 30, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations