Reliability of Elbow Flexion and Extension Strength Measu... | NCT04352673

Studies
Reliability of Elbow Flexion and Extension Strength Measurement Protocols Using a Hand-held Dynamometer

NCT04352673

Sponsor

Dokuz Eylul University

Status

Completed

Last Update Posted

Jan 12, 2023Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Healthy Individuals

Interventions

Elbow flexion and extension strength measurements using a hand-held dynamometer

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Actual

Primary Completion Date

Nov 23, 2022Actual

Completion Date

Nov 23, 2022Actual

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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°.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy individuals		Healthy students 18 years and older	Diagnostic Test: Elbow flexion and extension strength measurements using a hand-held dynamometer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elbow flexion and extension strength measurements using a hand-held dynamometer	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Elbow flexion measurements	Elbow flexion strength will be measured in 3 different positions.	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.	Measurements will be performed in two sessions (3-7 days between sessions)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Being older than 18 years old

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Students of Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sevgi Sevi Yesilyaprak, PhD	Dokuz Eylul University	Principal Investigator
Fatma Özden, MS	Dokuz Eylul University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dokuz Eylul University, School of Physical Therapy and Rehabilitation		Izmir	Balçova	35340	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided