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

Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Aging Problems
• Intervention / Treatment: Procedure: Manual Therapy

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Universidad de Valencia

Participation Criteria

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:

• 60 years or more

Exclusion Criteria:

• Do not sign the consent
• No acute pathology (3 months)
• Vestibular pathology
• CNS disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; No intervention
EXPERIMENTAL: Manual Therapy; 6 sessions of ankle manual therapy	Procedure: Manual Therapy; AP ankle mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test Up and Go	It is a test in which the functional mobility of the participant is measured.	Change from baseline to day 21
One Leg Balance Test	The time that the participant can be with monopodal support is measured	Change from baseline to day 21
Functional Reach Test	It measures the ability to move the center of gravity forward without losing balance.	Change from baseline to day 21
Analysis of Center of Pressure	Measurement of the displacement of the center of pressures using a Pressure Platform.	Change from baseline to day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active ankle range of movement	Measurement of the total active joint range of the ankle in discharge with a goniometer.	Change from baseline to day 21
Weight Bearing Dorsiflexion Lunge Test	Measurement of dorsiflexion of the ankle under load with an inclinometer.	Change from baseline to day 21
Falls Efficacy Scale	Scale that measures the worry of suffering a fall.	Change from baseline to day 21
Assessment of ankle plantar flexion muscle strength	Measurement of the strength of the plantar flexion of the ankle with a dynamometer.	Change from baseline to day 21

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: David Hernández-Guillén, PT, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): January 10, 2019

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (ACTUAL): November 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Balance; Ankle; Manual Therapy; Older Adult
• Other Study ID Numbers: DHG03

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