Relationship of de Ankle ROM With Balance and Falls in Older Adults (ANKLE_JOINT)

December 6, 2019 updated by: David Hernández, University of Valencia

Relationship of the Ankle ROM With Balance and Falls in Older Adults: Observational Study

The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. There is evidence to suggest that a lower range of motion in the ankle can negatively affect balance and, consequently, increase the risk of falls in the elderly. It would be interesting to assess if this relationship is true. The aim of the study will be to study if the state of the joint range of the ankle is related in some way to balance and falls in the elderly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Universidad de Valencia

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects must belong to the population of older adults, who must not present serious pathologies that make their balance or mobility difficult, although they can use aids.

Description

Inclusion Criteria:

  • Be 60 years old or older

Exclusion Criteria:

  • Do not sign the informed consent
  • Lower limb injury in the previous three months
  • Presenting severe pathology that affects balance or mobility

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Older adult
Individuals belonging to the population group of the elderly (60 years or more)
Other: Overall status
An assessment is made of the participants measuring both the joint range of the ankle and the balance and risk of falls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lunge Test (°)
Time Frame: Baseline
Measure of weight-bearing ankle dorsiflexion with an inclinometer.
Baseline
Active Ankle Range of Movement
Time Frame: Baseline
Measure of the active range of movement of the ankle with a telescopic goniometer.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Platform - Open Eyes
Time Frame: Baseline
Measure static balance. Quantitative assess of area and speed of swing, with open eyes.
Baseline
Pressure Platform - Closed Eyes
Time Frame: Baseline
Measure static balance. Quantitative assess of area and speed of swing, with closed eyes.
Baseline
One Leg Balance
Time Frame: Baseline
Measure balance ability to maintain in monopodal stance, towards registering time.
Baseline
Timed "Up and Go" Test
Time Frame: Baseline
Measures the functional mobility and dynamic balance, through a circuit where the subject will have to get up, walk and sit down.
Baseline
Functional Reach
Time Frame: Baseline
Measure the limits of stability, calculating the distance that can move the center of gravity forward without falling.
Baseline
Falls Efficacy Scale-International
Time Frame: Baseline
Is a scale that, through 16 items, describes the concern that a subject has to suffer a fall.
Baseline
Register of falls
Time Frame: Baseline
The number of falls that the subject has suffered in the last year is collected.
Baseline
Ankle plantar flexion strength
Time Frame: Baseline
The plantar flexion strength is measured by means of a dynamometer, is related with the risk of falls.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: David Hernández-Guillén, PT, University of Valencia
  • Study Director: Jose M Blasco, PhD, PT, University of Valencia

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)

April 1, 2019

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

March 30, 2019

First Submitted That Met QC Criteria

March 30, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DHG04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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