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CompletedNCT05573139Updated Oct 10, 2022

Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength

An interventional study of Assessment of muscle strength by manual dynamometry in Muscle Strength and Muscle Weakness, sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo. Completed at 1 site in Brazil. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by Faculdade de Ciências Médicas da Santa Casa de São Paulo · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Muscle Strength
  • Muscle Weakness

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03

In context

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

This study's enrollment of 26 is below the median of 44 across 362 interventional studies indexed under Muscle Weakness.

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Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 20-40 year
  • both sex
  • Healthy

Exclusion criteria

Exclusion Criteria:

  • individual who practiced physical activity,
  • cognitive disability
  • osteomioarticular diseases in lower limb and/or spine
  • rheumatic or cardiorespiratory disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    muscle strength assessment

    Diagnostic Test: Assessment of muscle strength by manual dynamometry

Interventions

  • Diagnostic testAssessment of muscle strength by manual dynamometry

    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.

06

What researchers measure

Primary outcomes

  1. Muscle strength assessment by hand dynamometer of the hip

    Assessment of muscle strength by hand dynamometer of the hip

    Time frame: 1 day (single assessment)

  2. Muscle strength assessment by hand dynamometer of the knee

    Assessment of muscle strength by hand dynamometer of the knee

    Time frame: 1 day (single assessment)

07

Study locations

1 site
  • Claudio Cazarini Júnior
    Sao Paulo, São Paulo 03156001, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05573139
Lead sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Responsible party
Sponsor
First posted
Oct 10, 2022
Start date
Mar 20, 2021
Primary completion
Jul 20, 2021
Completion
Dec 20, 2021
Last update
Oct 10, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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