Developing a Consensus Framework to Standardize Isokinetic Testing Data ReportingNCT06733116
Standardizing Reporting Practices for Isokinetic Testing: a Delphi Study
An observational study of Developing a Consensus Framework to Standardize Isokinetic Testing Data Reporting, run by University Hospital, Caen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Developing a Consensus Framework to Standardize Isokinetic Testing Data Reporting
- What is being tested?
- Delphi method survey
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population includes a diverse group of experts such as physicians, physiotherapists, kinesiologists, and sport physiologists. These professionals are selected for their expertise in isokinetic testing and its application in clinical practice, rehabilitation, and sports science. The panel aims to represent a broad range of perspectives to ensure a comprehensive and standardized framework for reporting isokinetic testing data.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
Read the 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.
- Being tested
- Delphi method survey
- Keywords
- isokinetic, Delphi method, strength assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi method surveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Delphi method survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus on Key Elements for Standardized Reporting of Isokinetic Testing
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')
Measured: At the completion of the final Delphi round (approximately 6 months).
Secondary outcomes (8)
Open Survey to Inform Delphi Rounds
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.
Measured: At the end of the first Delphi round (approximately 2 month)
Prioritization of Reporting Items
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.
Measured: During intermediate Delphi rounds (approximately 3-4 months).
Years of Professional Practice
Average and range of years of professional experience in fields related to isokinetic testing (e.g., sports medicine, rehabilitation, research).
Measured: At the beginning of the Delphi process (baseline).
Academic Contributions
Number of peer-reviewed publications or other academic contributions related to isokinetic testing or related fields, self-reported by the participants.
Measured: At the beginning of the Delphi process (baseline).
Geographic Distribution of Expert Panel Participants
Distribution of experts by geographic region (e.g., continents, countries) to evaluate the representativeness of the panel.
Measured: At the beginning of the Delphi process (baseline).
Expert Panel Composition - gender
Analysis of gender distribution within the expert panel
Measured: At the beginning of the Delphi process (baseline).
Expert Panel Composition - country
Analysis of the country of residence distribution within the expert panel
Measured: At the beginning of the Delphi process (baseline).
Expert Panel Composition - job
Analysis of the type of job distribution within the expert panel
Measured: At the beginning of the Delphi process (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developing a Consensus Framework to Standardize Isokinetic Testing Data ReportingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733116
- Sponsor's protocol ID
- Delph-iso
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36645122Wilk 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.
PubMed 38576833
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardizing Reporting Practices for Isokinetic Testing: a Delphi Study
- ClinicalTrials.gov ID
- NCT06733116
- Acronym / sponsor ID
- Delph-iso
- Keywords
- isokinetic, Delphi method, strength assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Dec 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group of experts in the field of isokinetic testing | – | Other: Delphi method surveyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes a diverse group of experts such as physicians, physiotherapists, kinesiologists, and sport physiologists. These professionals are selected for their expertise in isokinetic testing and its application in clinical practice, rehabilitation, and sports science. The panel aims to represent a broad range of perspectives to ensure a comprehensive and standardized framework for reporting isokinetic testing data.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Delphi method surveyThis 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. | Other | Group of experts in the field of isokinetic testing |
Primary outcome
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')
8 secondary outcomes
Open Survey to Inform Delphi Rounds
Time frame: 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).
Years of Professional Practice
Time frame: At the beginning of the Delphi process (baseline).
Academic Contributions
Time frame: At the beginning of the Delphi process (baseline).
Geographic Distribution of Expert Panel Participants
Time frame: At the beginning of the Delphi process (baseline).
Expert Panel Composition - gender
Time frame: At the beginning of the Delphi process (baseline).
Expert Panel Composition - country
Time frame: At the beginning of the Delphi process (baseline).
Expert Panel Composition - job
Time frame: At the beginning of the Delphi process (baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 36645122Schindler 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.
- Background: PubMed 38576833Wilk 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.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Developing a Consensus Framework to Standardize Isokinetic Testing Data Reporting, run by University Hospital, Caen.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joffrey DRIGNY, MD PhD (+33 0231064892, drigny-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus on Key Elements for Standardized Reporting of Isokinetic Testing (time frame: At the completion of the final Delphi round (approximately 6 months).). 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 NCT06733116, which also lists 2 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 17 Dec 2024.