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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03898999
Other study ID # DHG04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date September 1, 2019

Study information

Verified date December 2019
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date September 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Universidad de Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lunge Test (°) Measure of weight-bearing ankle dorsiflexion with an inclinometer. Baseline
Primary Active Ankle Range of Movement Measure of the active range of movement of the ankle with a telescopic goniometer. Baseline
Secondary Pressure Platform - Open Eyes Measure static balance. Quantitative assess of area and speed of swing, with open eyes. Baseline
Secondary Pressure Platform - Closed Eyes Measure static balance. Quantitative assess of area and speed of swing, with closed eyes. Baseline
Secondary One Leg Balance Measure balance ability to maintain in monopodal stance, towards registering time. Baseline
Secondary Timed "Up and Go" Test Measures the functional mobility and dynamic balance, through a circuit where the subject will have to get up, walk and sit down. Baseline
Secondary Functional Reach Measure the limits of stability, calculating the distance that can move the center of gravity forward without falling. Baseline
Secondary Falls Efficacy Scale-International Is a scale that, through 16 items, describes the concern that a subject has to suffer a fall. Baseline
Secondary Register of falls The number of falls that the subject has suffered in the last year is collected. Baseline
Secondary Ankle plantar flexion strength The plantar flexion strength is measured by means of a dynamometer, is related with the risk of falls. Baseline
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