Healthy IndividualsNCT04352673
Reliability of Elbow Flexion and Extension Strength Measurement Protocols Using a Hand-held Dynamometer
An observational study of Healthy Individuals, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the intra-rater and inter-rater reliability of elbow strength measurement procedures performed in different body postures and shoulder and elbow positions using a hand-held dynamometer in healthy individuals and to determine the standard error of measurement (SEM) and minimum… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Elbow flexion and extension strength measurements using a hand-held dynamometer
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2022to 23 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students of Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Who may be able to join
- -Being older than 18 years old
Who cannot join
- Having neck, shoulder, elbow or forearm injuries in the last 6 months,
- Having upper extremity or neck fracture or surgical history
- Symptoms related to the neck, shoulder, elbow, and forearm at the time of assessment
- Having neurological or systemic musculoskeletal diseases or disorders
- Having a diagnosis of chest deformity or scoliosis
- Doing regular exercise related to upper extremity for the last year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Izmir, Balçova, 35340
About this study
The aim of the study was to investigate the intra-rater and inter-rater reliability of elbow strength measurement procedures performed in different body postures and shoulder and elbow positions using a hand-held dynamometer in healthy individuals and to determine the standard error of measurement (SEM) and minimum detectable change (MDC) values for these procedures.
Read the detailed description
Healthy university students aged 18 years and older will be included in the study. Elbow flexion and extension strength will be measured in both arms in different body postures and shoulder and elbow positions using a hand-held dynamometer. Thus, the reliability of these procedures will be investigated, and the standard error of the measurement and the minimum detectable change will be determined. Strength measurements will be performed by two physiotherapists on each arm of the participants and repeated between 3 - 7 days after the measurement to evaluate both intra-rater and inter-rater reliability.
3 different positions will be used for elbow flexion:
- Participants sit on a stool, and their arms are at the side with the elbow flexed 90° (forearm in supination).
- Participants sit on a stool, and their shoulder and elbow are flexed to 90° (forearm in supination) and supported on the treatment table.
- Participants lie supine and place their shoulders on neutral position and elbow flexed 90° (forearm in supination).
3 different positions will be used for elbow extension:
- Participants sit on a stool, and their shoulder and elbow are flexed to 90° (forearm in supination) and supported on the treatment table.
- Participants lie supine and place their shoulders on neutral position and elbow flexed 90° (forearm in supination).
- Participants lie prone, and their shoulders аre placed at 90° abduction and elbows flexed to 90°.
- Conditions
- Healthy Individuals
- Being tested
- Elbow flexion and extension strength measurements using a hand-held dynamometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow flexion and extension strength measurements using a hand-held dynamometerDiagnostic test
Elbow flexion and extension strength of the participants will be measured in both arms in the supine, prone, and sitting positions using a hand-held dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Healthy students 18 years and older Receives: Diagnostic Test: Elbow flexion and extension strength measurements using a hand-held dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow flexion measurements
Elbow flexion strength will be measured in 3 different positions.
Measured: Measurements will be performed in two sessions (3-7 days between sessions)
Elbow extension measurements
Elbow extension strength will be measured in 3 different positions.
Measured: Measurements will be performed in two sessions (3-7 days between sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start21 Mar 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Karabay, Dokuz Eylul University
- Investigators
- Sevgi Sevi Yesilyaprak, PhD, Principal investigator, Dokuz Eylul UniversityFatma Özden, MS, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352673
- Sponsor's protocol ID
- 5001-GOA
- Status last verified
- Jan 2023
- First submitted
- 16 Apr 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Elbow Flexion and Extension Strength Measurement Protocols Using a Hand-held Dynamometer
- ClinicalTrials.gov ID
- NCT04352673
- Acronym / sponsor ID
- 5001-GOA
- Conditions
- Healthy Individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 20 Apr 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 aim of the study was to investigate the intra-rater and inter-rater reliability of elbow strength measurement procedures performed in different body postures and shoulder and elbow positions using a hand-held dynamometer in healthy individuals and to determine the standard error of measurement (SEM) and minimum detectable change (MDC) values for these procedures.
Detailed description
Healthy university students aged 18 years and older will be included in the study. Elbow flexion and extension strength will be measured in both arms in different body postures and shoulder and elbow positions using a hand-held dynamometer. Thus, the reliability of these procedures will be investigated, and the standard error of the measurement and the minimum detectable change will be determined. Strength measurements will be performed by two physiotherapists on each arm of the participants and repeated between 3 - 7 days after the measurement to evaluate both intra-rater and inter-rater reliability.
3 different positions will be used for elbow flexion:
- Participants sit on a stool, and their arms are at the side with the elbow flexed 90° (forearm in supination).
- Participants sit on a stool, and their shoulder and elbow are flexed to 90° (forearm in supination) and supported on the treatment table.
- Participants lie supine and place their shoulders on neutral position and elbow flexed 90° (forearm in supination).
3 different positions will be used for elbow extension:
- Participants sit on a stool, and their shoulder and elbow are flexed to 90° (forearm in supination) and supported on the treatment table.
- Participants lie supine and place their shoulders on neutral position and elbow flexed 90° (forearm in supination).
- Participants lie prone, and their shoulders аre placed at 90° abduction and elbows flexed to 90°.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Diagnostic Test: Elbow flexion and extension strength measurements using a hand-held dynamometerHealthy students 18 years and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students of Dokuz Eylul University, School of Physical Therapy and Rehabilitation
Key inclusion criteria (1 listed)
- -Being older than 18 years old
Key exclusion criteria (6 listed)
- Having neck, shoulder, elbow or forearm injuries in the last 6 months,
- Having upper extremity or neck fracture or surgical history
- Symptoms related to the neck, shoulder, elbow, and forearm at the time of assessment
- Having neurological or systemic musculoskeletal diseases or disorders
- Having a diagnosis of chest deformity or scoliosis
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 |
|---|---|---|
| Elbow flexion and extension strength measurements using a hand-held dynamometerElbow flexion and extension strength of the participants will be measured in both arms in the supine, prone, and sitting positions using a hand-held dynamometer. | Diagnostic test | Healthy individuals |
Primary outcome
Elbow flexion measurements
Time frame: Measurements will be performed in two sessions (3-7 days between sessions)
Elbow flexion strength will be measured in 3 different positions.
Elbow extension measurements
Time frame: Measurements will be performed in two sessions (3-7 days between sessions)
Elbow extension strength will be measured in 3 different positions.
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 12 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Sevgi Sevi Yesilyaprak, PhD principal investigator
Dokuz Eylul University
Fatma Özden, MS study chair
Dokuz Eylul University
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 Healthy Individuals, run by Dokuz Eylul 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 6 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 12 Jan 2023. 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?
Elbow flexion measurements (time frame: Measurements will be performed in two sessions (3-7 days between sessions)). 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?
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 12 Jan 2023.