- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06733116
Standardizing Reporting Practices for Isokinetic Testing: a Delphi Study
Isokinetic testing plays a crucial role in research and clinical practice, particularly for evaluating muscle strength, functional performance, and imbalances between muscle groups in fields such as rehabilitation, sports medicine, and orthopedics. Despite its widespread use, there is no international consensus on how to standardize protocols or report results, leading to significant variability in methodologies, measurement parameters, and data presentation.
This Delphi method study aims to develop a consensus framework for standardizing the reporting of isokinetic testing data, ensuring consistency and comparability in research and clinical practices.
Study Overview
Status
Intervention / Treatment
Detailed Description
Isokinetic tests are widely used in research and clinical practice to evaluate muscle strength, imbalances between muscle groups, and functional performance. These assessments are particularly important in rehabilitation, sports medicine, and orthopedics. However, the diversity in testing protocols, measured parameters, and reporting methods creates significant challenges for the comparability and interpretation of results.
Currently, there is no international consensus on how to report isokinetic test results. Scientific publications and clinical reports vary greatly in methodologies, units of measurement, and presentation of findings. Additionally, there is considerable heterogeneity in how results are presented, particularly regarding essential elements that ensure methodological reproducibility. This variability complicates the synthesis of data across studies and limits their practical application. As a result, healthcare professionals and researchers struggle to compare results, replicate studies, or effectively use the data in clinical decision-making.
The need to standardize reporting practices for isokinetic tests is therefore clear. A standardized framework would harmonize reporting, facilitate comparisons between studies, support the evaluation of therapeutic interventions, and improve the monitoring of patients or athletes over time. It would also enhance transparency and scientific rigor, which are critical for advancing knowledge and improving care.
The Delphi method, used in this study, is particularly suited to addressing this issue. It relies on an iterative process to gather the opinions of a panel of experts and establish a consensus on specific recommendations. By involving experts from various fields (physicians, physiotherapists, kinesiologists, and sport physiologists), this method ensures that the recommendations reflect a broad and balanced perspective. It also helps structure and prioritize key points, identifying essential elements for a standardized report.
The results of this study are expected to have several significant outcomes. First, they will provide a clear framework for standardizing the reporting of isokinetic tests, improving the quality and utility of the data reported. Second, this framework could be adopted internationally, fostering better collaboration between researchers and clinicians. Finally, it could serve as a foundation for developing official guidelines or recommendations, enhancing the validity and impact of isokinetic testing in clinical and scientific practices.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joffrey DRIGNY, MD PhD
- Phone Number: +33 0231064892
- Email: drigny-j@chu-caen.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Demonstrated knowledge or experience in isokinetic testing, such as research, clinical practice, or equipment design.
- Clinicians, researchers, educators, or professionals with relevant expertise in rehabilitation, sports medicine, biomechanics, or related fields.
- At least 5 peer-reviewed publication (first author) or equivalent contribution in the field of isokinetic testing or related domains.
- Minimum of 5 years of professional experience in a relevant field.
- Agreement to participate in all Delphi rounds and provide informed consent.
- Ability to communicate and provide responses in the language used for the study (English).
Exclusion Criteria:
- Professionals with conflicts of interest that could bias their contributions, such as direct financial ties to specific isokinetic testing equipment manufacturers.
- Inability or unwillingness to commit to the iterative Delphi process, including providing timely responses to questionnaires.
- Accidental inclusion of an expert already represented in another capacity within the study (e.g., as a member of the organizing committee).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group of experts in the field of isokinetic testing
A panel of experts in isokinetic testing, including physicians, physiotherapists, kinesiologists and exercise physiologists with significant expertise and recognition, will participate in a Delphi process to establish a consensus on standardizing data reporting.
|
This intervention involves a Delphi method study, where a panel of experts in isokinetic testing will collaborate to reach a consensus on best practices for standardizing the reporting of isokinetic test data.
Unlike other clinical studies, this intervention focuses on gathering expert opinions iteratively to establish a unified framework for data reporting, without direct clinical or experimental treatment.
The process includes multiple rounds of feedback, refining key elements related to testing protocols, measurement parameters, and result presentation, ensuring broad expertise from various fields such as medicine, rehabilitation, and biomechanics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Consensus on Key Elements for Standardized Reporting of Isokinetic Testing
Time Frame: At the completion of the final Delphi round (approximately 6 months).
|
The proportion of agreement among experts on the key elements to include in a standardized framework for reporting isokinetic testing data, as determined by the final round of the Delphi process.
Agreement will be defined as at least 80% agreement (4 or 5 on a 5 -level Likert scale, minimum=1 maximum=5, 5 corresponding to 'strongly agree')
|
At the completion of the final Delphi round (approximately 6 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Years of Professional Practice
Time Frame: At the beginning of the Delphi process (baseline).
|
Average and range of years of professional experience in fields related to isokinetic testing (e.g., sports medicine, rehabilitation, research).
|
At the beginning of the Delphi process (baseline).
|
|
Academic Contributions
Time Frame: At the beginning of the Delphi process (baseline).
|
Number of peer-reviewed publications or other academic contributions related to isokinetic testing or related fields, self-reported by the participants.
|
At the beginning of the Delphi process (baseline).
|
|
Open Survey to Inform Delphi Rounds
Time Frame: At the end of the first Delphi round (approximately 2 month)
|
The identification and categorization of items related to isokinetic testing, informed by an initial literature review and expert input during Round 1 of the Delphi process.
|
At the end of the first Delphi round (approximately 2 month)
|
|
Prioritization of Reporting Items
Time Frame: During intermediate Delphi rounds (approximately 3-4 months).
|
Ranking of reporting items by importance ("1 = optional", "2 = recommended", "3 = essential"), with 'essential' indicating that the item is mandatory, based on iterative feedback from Delphi panelists.
|
During intermediate Delphi rounds (approximately 3-4 months).
|
|
Geographic Distribution of Expert Panel Participants
Time Frame: At the beginning of the Delphi process (baseline).
|
Distribution of experts by geographic region (e.g., continents, countries) to evaluate the representativeness of the panel.
|
At the beginning of the Delphi process (baseline).
|
|
Expert Panel Composition - gender
Time Frame: At the beginning of the Delphi process (baseline).
|
Analysis of gender distribution within the expert panel
|
At the beginning of the Delphi process (baseline).
|
|
Expert Panel Composition - country
Time Frame: At the beginning of the Delphi process (baseline).
|
Analysis of the country of residence distribution within the expert panel
|
At the beginning of the Delphi process (baseline).
|
|
Expert Panel Composition - job
Time Frame: At the beginning of the Delphi process (baseline).
|
Analysis of the type of job distribution within the expert panel
|
At the beginning of the Delphi process (baseline).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Schindler IFSR, Pontes SS, Bertoni MBM, Junior GF, Junior BRN, de Jesus FLA, Neto MG. A Systematic Review of Isokinetic Muscle Strength in a Healthy Population With Special Reference to Age and Gender. Sports Health. 2023 May;15(3):328-332. doi: 10.1177/19417381221146258. Epub 2023 Jan 16.
- Wilk KE, Arrigo CA, Davies GJ. Isokinetic Testing: Why it is More Important Today than Ever. Int J Sports Phys Ther. 2024 Apr 1;19(4):374-380. doi: 10.26603/001c.95038. eCollection 2024.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Delph-iso
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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