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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03526198
Other study ID # 56483816.8.0000.5497
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date July 30, 2016

Study information

Verified date May 2018
Source Universidade Cruzeiro do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study developed a controlled soil reaction force platform that provided controlled mechanical stimuli to quantify the distribution of the center of mass as a function of the angular variation of the ankle in the elderly in the upright position.


Description:

Usually the balance evaluation the center of mass displacement for the analysis of postural control is assessed by means of force platforms. However, most of these devices are stationary, that is the patient is the dynamic element which can generate an evaluation with high subjectivity index. Therefore, this study aimed at developed a reaction force to the ground platform which provides mechanical stimuli controlled to quantify the distribution of the mass center as a function of the angular variation in the elderly ankle in the upright position. The construction of the prototype was divided into 3 steps, based on the two-dimensional movement of the ankle joint. In the 1st stage the construction of the mechanical assembly; in the 2nd stage development of the electronics; and 3rd stage the development of the supervisory system (control system). The force plataform was evaluated following the engineering functional tests such as: characterization and calibration of the sensors, the definition of the transfer function and accuracy of tests of angular movements (+ 10 ° and -10 ° to the movements of inversion and eversion, + 15 and -15º to the movements of dorsiflexion and plantar flexion). For the tests with volunteers were selected 30 volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 30, 2016
Est. primary completion date July 20, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- We included in this study individuals male and female

- Age ranging from 20 to 85 years

- Asymptomatic individuals

- Must walk without the use of an attachment

- Do not present motor deficit that makes the study impossible

Exclusion Criteria:

- Decompensated congestive heart failure

- Neurological or neurological diseases that interfere with significant neuromotor

- Individuals who did not agree to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Force plate
Device: force plate An equipment model with the approach of providing the evaluated person with the movement that is closest to the biomechanical and functional reality of the ankle and foot joint and which could equalize the possible changes of the center of mass would contribute to the clinical evaluation and would provide a more efficient therapeutic reasoning rehabilitation.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Cruzeiro do Sul

Outcome

Type Measure Description Time frame Safety issue
Primary Mass distribution The center of mass was measured by the patient remaining on the force platform, remaining for 10 seconds in each angulation variant Unit of measurement: Kilograms (kg) 15 minutes
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