NCT03526198

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

19 days

First QC Date

May 3, 2018

Last Update Submit

May 15, 2018

Conditions

Keywords

Force plateCenter of mass

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group 1 (adult)

EXPERIMENTAL

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

Group 2 (elderly)

EXPERIMENTAL

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

Interventions

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.

Group 1 (adult)Group 2 (elderly)

Eligibility Criteria

Age20 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details30 individuals, asymptomatic
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Decompensated congestive heart failure
  • Neurological or neurological diseases that interfere with significant neuromotor
  • Individuals who did not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 3, 2018

First Posted

May 16, 2018

Study Start

July 1, 2016

Primary Completion

July 20, 2016

Study Completion

July 30, 2016

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share