Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03898999
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
David Hernández, University of Valencia

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.

Condition or disease Intervention/treatment
Aging Problems Other: Overall status

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship of the Ankle ROM With Balance and Falls in Older Adults: Observational Study
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : May 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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.




Primary Outcome Measures :
  1. Lunge Test (°) [ Time Frame: Baseline ]
    Measure of weight-bearing ankle dorsiflexion with an inclinometer.

  2. Active Ankle Range of Movement [ Time Frame: Baseline ]
    Measure of the active range of movement of the ankle with a telescopic goniometer.


Secondary Outcome Measures :
  1. Pressure Platform - Open Eyes [ Time Frame: Baseline ]
    Measure static balance. Quantitative assess of area and speed of swing, with open eyes.

  2. Pressure Platform - Closed Eyes [ Time Frame: Baseline ]
    Measure static balance. Quantitative assess of area and speed of swing, with closed eyes.

  3. One Leg Balance [ Time Frame: Baseline ]
    Measure balance ability to maintain in monopodal stance, towards registering time.

  4. 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.

  5. Functional Reach [ Time Frame: Baseline ]
    Measure the limits of stability, calculating the distance that can move the center of gravity forward without falling.

  6. 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.

  7. Register of falls [ Time Frame: Baseline ]
    The number of falls that the subject has suffered in the last year is collected.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898999


Contacts
Layout table for location contacts
Contact: David Hernández-Guillén, PT +34963864100 david.hernandez@uv.es
Contact: Jose M Blasco, PhD, PT +34963864100 jose.maria.blasco@uv.es

Locations
Layout table for location information
Spain
Universidad de Valencia Recruiting
Valencia, Spain, 46010
Contact: David Hernández-Guillén, PT    +34963864100    david.hernandez@uv.es   
Contact: Jose M Blasco, PhG    +34963864100    jose.maria.blasco@uv.es   
Sponsors and Collaborators
University of Valencia
Investigators
Layout table for investigator information
Principal Investigator: David Hernández-Guillén, PT University of Valencia
Study Director: Jose M Blasco, PhD, PT University of Valencia

Layout table for additonal information
Responsible Party: David Hernández, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT03898999     History of Changes
Other Study ID Numbers: DHG04
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Hernández, University of Valencia:
Ankle
Balance
Falls
Older Adult