- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092869
Effects of Feet and Ankle Mobilization on Balance of Older Adults (FEET_BALANCE)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46010
- University of Valencia
-
Valencia, Spain, 46010
- Universidad de Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: David Hernández, PT, University of Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DHG01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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