Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
Primary Purpose
Muscle Strength, Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Assessment of muscle strength by manual dynamometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscle Strength
Eligibility Criteria
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
Sites / Locations
- Claudio Cazarini Júnior
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
muscle strength assessment
Arm Description
Outcomes
Primary Outcome Measures
Muscle strength assessment by hand dynamometer of the hip
Assessment of muscle strength by hand dynamometer of the hip
Muscle strength assessment by hand dynamometer of the knee
Assessment of muscle strength by hand dynamometer of the knee
Secondary Outcome Measures
Full Information
NCT ID
NCT05573139
First Posted
April 27, 2022
Last Updated
October 5, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05573139
Brief Title
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
Official Title
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength: Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Keywords: Muscle Strength; Muscle Strength Dynamometer; Lower Extremity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Strength, Muscle Weakness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
muscle strength assessment
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of muscle strength by manual dynamometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength assessment by hand dynamometer of the hip
Description
Assessment of muscle strength by hand dynamometer of the hip
Time Frame
1 day (single assessment)
Title
Muscle strength assessment by hand dynamometer of the knee
Description
Assessment of muscle strength by hand dynamometer of the knee
Time Frame
1 day (single assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Claudio Cazarini Júnior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
03156001
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reliability and Validation of New Manual Dynamometer to Measure Lower Limb Strength
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