ArmNCT04685434
Validity and Reliability of "Shriners Hospital Upper Extremity Evaluation" in Children With Rheumatic Disease
An observational study of Arm and Rheumatic Diseases, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Arm, Rheumatic Diseases, Child, Only
- What is being tested?
- Shriners Hospital for Children Upper Extremity Evaluation
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2020to 30 Mar 2021
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: the patients who applied to the pediatric rheumatology clinic in the university hospital
Who may be able to join
- 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
Who cannot join
- Having an acute pathology that could affect walking
- To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability Study of "Shriners Hospital for Children Upper Extremity Evaluation" in Children With Rheumatic Disease
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.
Read more
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.
Read the detailed 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.
- Conditions
- Arm, Rheumatic Diseases, Child, Only
- Being tested
- Shriners Hospital for Children Upper Extremity Evaluation
- Keywords
- rheumatic diseases, children, function
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shriners Hospital for Children Upper Extremity EvaluationOther
Also called Jebsen-Taylor Hand Function Test, Childhood Health Assessment Questionnaire
The interventions are evaluating tools for the functional performance of the upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shriners Hospital for Children Upper Extremity Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: after two weeks from baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start4 Nov 2020
- Primary completion15 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArmStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokce Leblebici, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685434
- Sponsor's protocol ID
- IstanbulUC_34
- Status last verified
- Aug 2021
- First submitted
- 12 Dec 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16452744Ozdogan 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.
PubMed 11510322Sigirtmac 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.
PubMed 32156578
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of "Shriners Hospital for Children Upper Extremity Evaluation" in Children With Rheumatic Disease
- ClinicalTrials.gov ID
- NCT04685434
- Acronym / sponsor ID
- IstanbulUC_34
- Conditions
- Arm, Rheumatic Diseases, Child, Only
- Keywords
- rheumatic diseases, children, function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients diagnosed with rheumatic diseases. | – | Other: Shriners Hospital for Children Upper Extremity EvaluationThe 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- the patients who applied to the pediatric rheumatology clinic in the university hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Having an acute pathology that could affect walking
- To be diagnosed with orthopedic/neurological pathology that will affect work and cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shriners Hospital for Children Upper Extremity EvaluationAlso: Jebsen-Taylor Hand Function Test, Childhood Health Assessment QuestionnaireThe interventions are evaluating tools for the functional performance of the upper extremity. | Other | pediatric patients diagnosed with rheumatic diseases. |
Primary outcome
Shriners Hospital Upper Extremity Evaluation
Time frame: Baseline
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.
Jebsen-Taylor Hand Function Test
Time frame: Baseline
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.
Shriners Hospital Upper Extremity Evaluation
Time frame: after two weeks from baseline
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.
1 secondary outcome
The Childhood Health Assessment Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Background: PubMed 16452744Davids 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.
- Background: PubMed 11510322Ozdogan 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.
- Background: PubMed 32156578Sigirtmac 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arm and Rheumatic Diseases, run by Istanbul University - Cerrahpasa 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 3 inclusion and 2 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 31 Aug 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?
Shriners Hospital Upper Extremity Evaluation (time frame: Baseline). The study lists 3 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 NCT04685434, which also lists 3 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 31 Aug 2021.