NCT03898999

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

March 30, 2019

Last Update Submit

December 6, 2019

Conditions

Keywords

AnkleBalanceFallsOlder Adult

Outcome Measures

Primary Outcomes (2)

  • Lunge Test (°)

    Measure of weight-bearing ankle dorsiflexion with an inclinometer.

    Baseline

  • Active Ankle Range of Movement

    Measure of the active range of movement of the ankle with a telescopic goniometer.

    Baseline

Secondary Outcomes (8)

  • Pressure Platform - Open Eyes

    Baseline

  • Pressure Platform - Closed Eyes

    Baseline

  • One Leg Balance

    Baseline

  • Timed "Up and Go" Test

    Baseline

  • Functional Reach

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

Older adult

Individuals belonging to the population group of the elderly (60 years or more)

Other: Overall status

Interventions

An assessment is made of the participants measuring both the joint range of the ankle and the balance and risk of falls.

Older adult

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Be 60 years old or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Health Status

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • David Hernández-Guillén, PT

    University of Valencia

    PRINCIPAL INVESTIGATOR
  • Jose M Blasco, PhD, PT

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2019

First Posted

April 2, 2019

Study Start

April 1, 2019

Primary Completion

May 1, 2019

Study Completion

September 1, 2019

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations