NCT05573139

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

April 27, 2022

Last Update Submit

October 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle strength assessment by hand dynamometer of the hip

    Assessment of muscle strength by hand dynamometer of the hip

    1 day (single assessment)

  • Muscle strength assessment by hand dynamometer of the knee

    Assessment of muscle strength by hand dynamometer of the knee

    1 day (single assessment)

Study Arms (1)

muscle strength assessment

EXPERIMENTAL
Diagnostic Test: Assessment of muscle strength by manual dynamometry

Interventions

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.

muscle strength assessment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year
  • both sex
  • Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Cazarini Júnior

São Paulo, São Paulo, 03156001, Brazil

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

October 10, 2022

Study Start

March 20, 2021

Primary Completion

July 20, 2021

Study Completion

December 20, 2021

Last Updated

October 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations