- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526198
Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground
May 15, 2018 updated by: Leandro Lazzareschi, Universidade Cruzeiro do Sul
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1 (adult)
Each volunteer stood on the platform.
The duration of the tests was standardized at 10 seconds for each angulation variant of the test.
The tilt variables occurred every 5 degrees oscillating in the two-dimensional movement of the ankle joint.
The test was discontinued when the volunteer failed to remain balanced at the tested angulation for more than 10 seconds (thus shifting the foot (s) from the initial position or supporting with one and / or both arms at the therapist or at the support bars ) or when it reached maximum angulation
|
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.
|
EXPERIMENTAL: Group 2 (elderly)
Each volunteer stood on the platform.
The duration of the tests was standardized at 10 seconds for each angulation variant of the test.
The tilt variables occurred every 5 degrees oscillating in the two-dimensional movement of the ankle joint.
The test was discontinued when the volunteer failed to remain balanced at the tested angulation for more than 10 seconds (thus shifting the foot (s) from the initial position or supporting with one and / or both arms at the therapist or at the support bars ) or when it reached maximum angulation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mass distribution
Time Frame: 15 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2016
Primary Completion (ACTUAL)
July 20, 2016
Study Completion (ACTUAL)
July 30, 2016
Study Registration Dates
First Submitted
May 3, 2018
First Submitted That Met QC Criteria
May 3, 2018
First Posted (ACTUAL)
May 16, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 15, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 56483816.8.0000.5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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