NCT04352673

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.

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 Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

April 16, 2020

Last Update Submit

January 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

Healthy individuals

Healthy students 18 years and older

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

Interventions

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.

Healthy individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Being older than 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

Study Officials

  • Sevgi Sevi Yesilyaprak, PhD

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR
  • Fatma Özden, MS

    Dokuz Eylul University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 20, 2020

Study Start

March 21, 2022

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations