Effects of Feet and Ankle Mobilization on Balance of Older Adults (FEET_BALANCE)

June 7, 2018 updated by: David Hernández, University of Valencia

This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly.

To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and foot joints.

Study Overview

Detailed Description

Aging leads to a decrease in physical activity and a reduction of postural control, which implies a loss of balance control, both static and dynamic, thus compromising the autonomy of the elderly and increasing the risk of suffering a fall. It has been observed that the balance degenerates in an accelerated way from 60 years of age. Basically appears a natural physiological degeneration of the organism, which affects strength, range of mobility, reduces vestibular function, there is loss vision and lower cardiopulmonary capacity.

In the older adult who suffers falls, in relation to the one who does not suffer, a series of differences or determinants have been observed. In this group, a series of characteristics such as the lower flexibility of the ankle joint and the muscle-tendon complex are present, hallux valgus appears, lower foot tenderness or a decrease in the strength in the first plantar flexor finger. They appear to have poorer balance and have less force in the flexors of the soles accompanied by less mobility of the foot inversion-eversion.

One of the causes that seems to contribute in the decrease of the balance in the older adult are the alterations in the ankle and foot, besides supposing a worse capacity of adaptation to the possible environmental changes. Before a deficit of this type, the subject tends to compensate for his position with compensatory strategies in other joints of the lower limb. It has also been shown that as we grow older, there is an increase in the demand for articulation of the other joints, such as the hip and knee, secondary to a decrease in joint range of ankle and foot or weakness of the dorsal flexors of the foot.

It follows that there is a relationship between alterations in the ankle and foot and the balance in the elderly, all related to the forces that suffer the ankle in the gait and to the low normal activity. Any alteration in this joint could predetermine an alteration of its function in maintaining stability in the elderly.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

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

      • Valencia, Spain, 46010
        • University of Valencia
      • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Old adults over 60 years

Exclusion Criteria:

  • Subjects with balance disorders whether vestibular or central.
  • Subjects with lower limb prosthesis.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Feet and Ankle Mobilization
A set of manual therapy mobilization in feet and ankle joints
A set of proprioceptive exercises oriented to improve balance abilities
Active Comparator: Control Group
Proprioceptive Training
A set of proprioceptive exercises oriented to improve balance abilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: Change from baseline to end of intervention (one month)
This is a 14 item scale used to assess the overall state of balance of the oder adult
Change from baseline to end of intervention (one month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Up and Go
Time Frame: Change from baseline to end of intervention (one month)
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Change from baseline to end of intervention (one month)
Pressure Platform Outcome
Time Frame: Change from baseline to end of intervention (one month)
Romberg test. Static balance when standing in the platform in a static position without moving the feet during 30 seconds
Change from baseline to end of intervention (one month)
Range of Movement
Time Frame: Change from baseline to end of intervention (one month)
Flexion-extension range of movement of the ankle joint
Change from baseline to end of intervention (one month)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David Hernández, 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 3, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 2, 2017

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • DHG01

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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