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Effects of Improvement of the Ankle Joint Range on Balance in the Elderly. (ANKLE_ROM)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743857
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
David Hernández, University of Valencia

Study Description
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Brief Summary:
The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.

Condition or disease Intervention/treatment Phase
Aging Problems Procedure: Manual Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : January 10, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Manual Therapy
6 sessions of ankle manual therapy
 Procedure: Manual Therapy
AP ankle mobilization
No Intervention: Control
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Test Up and Go [ Time Frame: Change from baseline to day 21 ]
    It is a test in which the functional mobility of the participant is measured.

  2. One Leg Balance Test [ Time Frame: Change from baseline to day 21 ]
    The time that the participant can be with monopodal support is measured

  3. Functional Reach Test [ Time Frame: Change from baseline to day 21 ]
    It measures the ability to move the center of gravity forward without losing balance.

  4. Analysis of Center of Pressure [ Time Frame: Change from baseline to day 21 ]
    Measurement of the displacement of the center of pressures using a Pressure Platform.


Secondary Outcome Measures :
  1. Active ankle range of movement [ Time Frame: Change from baseline to day 21 ]
    Measurement of the total active joint range of the ankle in discharge with a goniometer.

  2. Weight Bearing Dorsiflexion Lunge Test [ Time Frame: Change from baseline to day 21 ]
    Measurement of dorsiflexion of the ankle under load with an inclinometer.

  3. Falls Efficacy Scale [ Time Frame: Change from baseline to day 21 ]
    Scale that measures the worry of suffering a fall.

  4. Assessment of ankle plantar flexion muscle strength [ Time Frame: Change from baseline to day 21 ]
    Measurement of the strength of the plantar flexion of the ankle with a dynamometer.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60 years or more

Exclusion Criteria:

  • Do not sign the consent
  • No acute pathology (3 months)
  • Vestibular pathology
  • CNS disease
Contacts and Locations
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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): NCT03743857


Locations
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Spain
Universidad de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: David Hernández-Guillén, PT Study Principal Investigator
More Information
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Responsible Party: David Hernández, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT03743857    
Other Study ID Numbers: DHG03
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Manual Therapy
Older Adult