Muscle StrengthNCT05573139
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
A study testing Assessment of muscle strength by manual dynamometry in people with Muscle Strength and Muscle Weakness, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Muscle Weakness
- What is being tested?
- Assessment of muscle strength by manual dynamometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2021to 20 Dec 2021
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 year
- both sex
- Healthy
Who cannot join
- individual who practiced physical activity,
- cognitive disability
- osteomioarticular diseases in lower limb and/or spine
- rheumatic or cardiorespiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength: Clinical Study
INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Among them, a national equipment was developed, but its reliability and validation are yet to be confirmed, compared to equipment already used, such as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor® device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165), already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS: A total of 26 recruits of both sexes were selected. Muscle strength was measured by Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors; flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was collected 3 times, and then the average was calculated.
Read the detailed description
Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.
- Conditions
- Muscle Strength, Muscle Weakness
- Being tested
- Assessment of muscle strength by manual dynamometry
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of muscle strength by manual dynamometryDiagnostic test
The reliability and validation of a new manual dynamometer was verified, compared to one already used, in the muscle groups: knee extensors and flexors; hip extensors, flexors, abductors, adductors, internal and external rotators.
| Study group | Role | What they receive |
|---|---|---|
| muscle strength assessment | Experimental | Not described Receives: Diagnostic Test: Assessment of muscle strength by manual dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength assessment by hand dynamometer of the hip
Assessment of muscle strength by hand dynamometer of the hip
Measured: 1 day (single assessment)
Muscle strength assessment by hand dynamometer of the knee
Assessment of muscle strength by hand dynamometer of the knee
Measured: 1 day (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start20 Mar 2021
- Primary completion20 Jul 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrengthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573139
- Sponsor's protocol ID
- MEDEOR
- Status last verified
- Oct 2022
- First submitted
- 27 Apr 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength: Clinical Study
- ClinicalTrials.gov ID
- NCT05573139
- Acronym / sponsor ID
- MEDEOR
- Conditions
- Muscle Strength, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 10 Oct 2022 (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.
INTRODUCTION: There are several ways to assess muscle strength: not only subjective ways, but also high standard equipment, such as isokinetic dynamometers. These, however, are expensive, and require extensive training. Over the years, manual dynamometers were produced, portable equipment that simplify its use. Among them, a national equipment was developed, but its reliability and validation are yet to be confirmed, compared to equipment already used, such as the Lafayette®. OBJECTIVE: Assess the reliability of a new manual dynamometer - Medeor® device (SP Tech model) -, in relation to the gold standard, Lafayette® device (model 01165), already validated, in the evaluation of muscle strength of the knee and hip groups. METHODS: A total of 26 recruits of both sexes were selected. Muscle strength was measured by Lafayette® and Medeor® dynamometers in the following groups: knee flexors and extensors; flexors, extensors, abductors, adductors, hips internal and external rotators. Each data was collected 3 times, and then the average was calculated.
Detailed description
Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muscle strength assessment | Experimental | Diagnostic Test: Assessment of muscle strength by manual dynamometry |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-40 year
- both sex
- Healthy
Key exclusion criteria (4 listed)
- individual who practiced physical activity,
- cognitive disability
- osteomioarticular diseases in lower limb and/or spine
- rheumatic or cardiorespiratory disease
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 |
|---|---|---|
| Assessment of muscle strength by manual dynamometryThe reliability and validation of a new manual dynamometer was verified, compared to one already used, in the muscle groups: knee extensors and flexors; hip extensors, flexors, abductors, adductors, internal and external rotators. | Diagnostic test | muscle strength assessment |
Primary outcome
Muscle strength assessment by hand dynamometer of the hip
Time frame: 1 day (single assessment)
Assessment of muscle strength by hand dynamometer of the hip
Muscle strength assessment by hand dynamometer of the knee
Time frame: 1 day (single assessment)
Assessment of muscle strength by hand dynamometer of the knee
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Individual participant dataSharing planned: No
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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?
A study testing Assessment of muscle strength by manual dynamometry in people with Muscle Strength and Muscle Weakness, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Oct 2022. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle strength assessment by hand dynamometer of the hip (time frame: 1 day (single assessment)). The study lists 2 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 10 Oct 2022.