NCT03743857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

29 days

First QC Date

November 11, 2018

Last Update Submit

January 26, 2019

Conditions

Aging Problems

Keywords

AnkleBalanceManual TherapyOlder Adult

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Active ankle range of movement

    Change from baseline to day 21

  • Weight Bearing Dorsiflexion Lunge Test

    Change from baseline to day 21

  • Falls Efficacy Scale

    Change from baseline to day 21

  • Assessment of ankle plantar flexion muscle strength

    Change from baseline to day 21

Study Arms (2)

Manual Therapy

EXPERIMENTAL

6 sessions of ankle manual therapy

Procedure: Manual Therapy

Control

NO INTERVENTION

No intervention

Interventions

Manual TherapyPROCEDURE

AP ankle mobilization

Manual Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or more

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • David Hernández-Guillén, PT

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 16, 2018

Study Start

December 1, 2018

Primary Completion

December 30, 2018

Study Completion

January 10, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

ES(1)