Healthy PeopleRAVEHABDSNCT05140577
Reliability and Validity of the Evaluation of Hip Abductors Strength (RAVEHABDS)
An observational study of Healthy People, run by HES-SO Valais-Wallis at 1 site in Switzerland.
Trial summary
The aim is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy People
- What is being tested?
- Maximal voluntary isometric strengthening
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2021to 5 Jun 2024
- 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: The subjects will be healthy adults belonging to the three age groups mentioned above
Who may be able to join
- Persons over 18 years old, good understanding of French, German, English or Italian, with the capacity of discernment regarding their own participation in the study
Who cannot join
- Persons with cognitive impairment or who are unable to take their own decisions about participation in the study, or who have undergone surgery on the lower limb or lumbopelvic area during the last 6 months that could contradict or influence the strength tests, will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Sport Medical Center Ittigen
Ittigen, Canton of Bern, 3063
About this study
Official title: Reliability and Validity of the Measurement Procedure for the Evaluation of Hip Abductors Strength in Unipodal Standing Position
The aim is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles.
Read the detailed description
Within this Master thesis project, we will investigate intra- and inter-tester reliability, as well as construct validity of a measurement procedure to assess hip abductor strength in a closed-chain position. Additionally, we aim to investigate some aspects of feasibility using a questionnaire about the measurement procedure and by evaluating if the test can be completing in a suitable timeframe for practical use.
To investigate intra- and inter-tester reliability, as well as construct validity, we will analyze and compare the maximal voluntary isometric strength (MVIS) and the rate of force generated (RFG) of the three groups of healthy participant (group 1: 18-30 years old; group 2: 31-65 years old; group 3: 65+ years old).
- Conditions
- Healthy People
- Being tested
- Maximal voluntary isometric strengthening
- Keywords
- hip abductors strengthening, one-leg standing, maximal voluntary isometric strengthening, rate of force generated, dynamometer, aged category, so surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal voluntary isometric strengtheningOther
The subject is asked to perform a maximum voluntary isometric force work against a wall during 5 seconds
| Study group | Role | What they receive |
|---|---|---|
| 18-30 years old | Subjects in this group is aged between 18 ans 30 years old Receives: Other: Maximal voluntary isometric strengthening | |
| 31-65 years old | Subjects in this group is aged between 31 ans 65 years old Receives: Other: Maximal voluntary isometric strengthening | |
| 65+ years old | Subjects in this group is aged over 65 years old Receives: Other: Maximal voluntary isometric strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-tester Correlation
Strength of correlation the measured values
Measured: 1 March, 2022
Inter-tester correlation
Strength of correlation the measured values
Measured: 1 March, 2022
Construct validity
Difference between groups by comparing values
Measured: 1 March, 2022
Secondary outcomes (1)
Feasibility of the measurement procedure
Through the administration of a feasibility questionnaire we investigate the time to perform the test, the understanding of the instructions, the fatigue, the possible pain, or the fear of falling during the test
Measured: 1 March, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Nov 2021
- Primary completion28 Feb 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140577
- Sponsor's protocol ID
- 2021-01829
- Acronym
- RAVEHABDS
- Status last verified
- Sep 2023
- First submitted
- 22 Nov 2021
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sharing of our data will be done on request
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Measurement Procedure for the Evaluation of Hip Abductors Strength in Unipodal Standing Position
- ClinicalTrials.gov ID
- NCT05140577
- Acronym / sponsor ID
- RAVEHABDS / 2021-01829
- Conditions
- Healthy People
- Keywords
- hip abductors strengthening, one-leg standing, maximal voluntary isometric strengthening, rate of force generated, dynamometer, aged category, so surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 1 Dec 2021 (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 is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles.
Detailed description
Within this Master thesis project, we will investigate intra- and inter-tester reliability, as well as construct validity of a measurement procedure to assess hip abductor strength in a closed-chain position. Additionally, we aim to investigate some aspects of feasibility using a questionnaire about the measurement procedure and by evaluating if the test can be completing in a suitable timeframe for practical use.
To investigate intra- and inter-tester reliability, as well as construct validity, we will analyze and compare the maximal voluntary isometric strength (MVIS) and the rate of force generated (RFG) of the three groups of healthy participant (group 1: 18-30 years old; group 2: 31-65 years old; group 3: 65+ years old).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18-30 years old | – | Other: Maximal voluntary isometric strengtheningSubjects in this group is aged between 18 ans 30 years old |
| 31-65 years old | – | Other: Maximal voluntary isometric strengtheningSubjects in this group is aged between 31 ans 65 years old |
| 65+ years old | – | Other: Maximal voluntary isometric strengtheningSubjects in this group is aged over 65 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects will be healthy adults belonging to the three age groups mentioned above
Key inclusion criteria (1 listed)
- Persons over 18 years old, good understanding of French, German, English or Italian, with the capacity of discernment regarding their own participation in the study
Key exclusion criteria (1 listed)
- Persons with cognitive impairment or who are unable to take their own decisions about participation in the study, or who have undergone surgery on the lower limb or lumbopelvic area during the last 6 months that could contradict or influence the strength tests, will be excluded from the study
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 |
|---|---|---|
| Maximal voluntary isometric strengtheningThe subject is asked to perform a maximum voluntary isometric force work against a wall during 5 seconds | Other | 18-30 years old, 31-65 years old, 65+ years old |
Primary outcome
Intra-tester Correlation
Time frame: 1 March, 2022
Strength of correlation the measured values
Inter-tester correlation
Time frame: 1 March, 2022
Strength of correlation the measured values
Construct validity
Time frame: 1 March, 2022
Difference between groups by comparing values
1 secondary outcome
Feasibility of the measurement procedure
Time frame: 1 March, 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided. The sharing of our data will be done on request
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 People, run by HES-SO Valais-Wallis at 1 site in Switzerland.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 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 Switzerland. 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?
Results are not available in the source record.
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?
Intra-tester Correlation (time frame: 1 March, 2022). The study lists 3 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 26 Sep 2023.