Muscle Weakness Clinical Trial
Official title:
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength: Clinical Study
| NCT number | NCT05573139 |
| Other study ID # | MEDEOR |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 20, 2021 |
| Est. completion date | December 20, 2021 |
| Verified date | October 2022 |
| Source | Faculdade de Ciências Médicas da Santa Casa de São Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | December 20, 2021 |
| Est. primary completion date | July 20, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years to 40 Years |
| Eligibility | Inclusion Criteria: - 20-40 year - both sex - Healthy Exclusion Criteria: - individual who practiced physical activity, - cognitive disability - osteomioarticular diseases in lower limb and/or spine - rheumatic or cardiorespiratory disease |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Claudio Cazarini Júnior | Sao Paulo | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Faculdade de Ciências Médicas da Santa Casa de São Paulo |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Muscle strength assessment by hand dynamometer of the hip | Assessment of muscle strength by hand dynamometer of the hip | 1 day (single assessment) | |
| Primary | Muscle strength assessment by hand dynamometer of the knee | Assessment of muscle strength by hand dynamometer of the knee | 1 day (single assessment) |
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