NCT03092869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2017

Completed
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

March 22, 2017

Last Update Submit

June 7, 2018

Conditions

Aging Problems

Keywords

FeetAnkleBalanceManual TherapyOlder Adult

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    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 Outcomes (3)

  • Test Up and Go

    Change from baseline to end of intervention (one month)

  • Pressure Platform Outcome

    Change from baseline to end of intervention (one month)

  • Range of Movement

    Change from baseline to end of intervention (one month)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Feet and Ankle Mobilization

Other: Feet and Ankle MobilizationOther: Proprioceptive Training

Control Group

ACTIVE COMPARATOR

Proprioceptive Training

Other: Proprioceptive Training

Interventions

Feet and Ankle MobilizationOTHER

A set of manual therapy mobilization in feet and ankle joints

Experimental Group
Proprioceptive TrainingOTHER

A set of proprioceptive exercises oriented to improve balance abilities

Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • Old adults over 60 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de Valencia

Valencia, 46010, Spain

Location

University of Valencia

Valencia, 46010, Spain

Location

Study Officials

  • David Hernández, PT

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

April 3, 2017

Primary Completion

July 1, 2017

Study Completion

September 2, 2017

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

ES(2)