Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04685434
Other study ID # IstanbulUC_34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date March 30, 2021

Study information

Verified date August 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Various questionnaires and test batteries are available to evaluate the functional activities of the upper extremities in children with upper extremity involvement. Among these questionnaires and test batteries, there are different performance tests evaluating the grip, wrist, and elbow movements in the upper extremity due to rheumatic disease. In the literature, the most common performance tests used in children diagnosed with rheumatic disease are the 9-hole peg test and the 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 accessible in terms of cost, these tests are non-specific performance tests. There is no test battery that examines the mobility and position of each segment of the upper extremity during a function in detail for motor skills specific to children with rheumatic diseases. The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based assessment validated 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. SHUEE provides detailed information about the location of the upper extremity segments during the function. In addition, due to the video recording of the evaluation, it provides a detailed examination opportunity to the evaluator 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 30, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Having an acute pathology that could affect walking - To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Shriners Hospital for Children Upper Extremity Evaluation
The interventions are evaluating tools for the functional performance of the upper extremity.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Ozdogan H, Ruperto N, Kasapçopur 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. — View Citation

Sigirtmaç IC, Öksüz Ç. Investigation of reliability, validity, and cutoff value of the Jebsen-Taylor Hand Function Test. J Hand Ther. 2020 Mar 7. pii: S0894-1130(20)30024-7. doi: 10.1016/j.jht.2020.01.004. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 The Childhood Health Assessment Questionnaire It is a self-report questionnaire and is said to measure both disability and discomfort in children with chronic arthritis. It assesses functional ability in 8 domains of physical function (30 items) for children between the ages of 6 months up to 18 years. Each item is scored on a four-point scale ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), 3 (unable to do). Lower scores mean a better outcome. Baseline
See also
  Status Clinical Trial Phase
Completed NCT06190457 - Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
Recruiting NCT04691349 - CAR-T for r/r Malignant Tumors in Children Early Phase 1
Not yet recruiting NCT06455592 - Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years N/A
Not yet recruiting NCT05806983 - Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program N/A
Not yet recruiting NCT05566951 - Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents N/A
Recruiting NCT05329467 - Validation of Pain Assessment Scale Faces Thermometer Scale (FTS) N/A
Not yet recruiting NCT04016506 - Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
Recruiting NCT05761847 - Pediatric Medication Therapy Management Trial N/A
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Not yet recruiting NCT05943587 - The Development and Evaluation of Pain Neuroscience Education in Children N/A
Recruiting NCT05109013 - Juvenile Essential Arterial Hypertension and Vascular Function
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Completed NCT04040036 - Effects of Virtual Reality on Pain, Fear and Anxiety During Blood Draw in Children Aged 5-12 Years Old N/A
Completed NCT03312881 - Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Completed NCT04334733 - The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children N/A
Completed NCT06220383 - Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03244332 - HEMOCC Study. Hemostasis in Cirrhotic Children. N/A
Not yet recruiting NCT06299267 - The Effect of Dual Task on Manual Skill Performance in Children and Adolescents N/A
Active, not recruiting NCT04070131 - Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects N/A