NCT03161236

Brief Summary

This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration 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

Study Start

First participant enrolled

October 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2.6 years

First QC Date

March 15, 2017

Last Update Submit

July 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Y Balance Test

    The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.

    change from baseline to 4 weeks

  • Y Balance Test

    The test assesses performance during single-leg balance with a reaching task in the anterior (ANT), posteromedial (PM), and posterolateral (PL) directions to determine lower extremity movement asymmetry and balance deficits. ANT, PM, and PL are a composite measurement.

    change from 4 weeks to 8 weeks

Secondary Outcomes (2)

  • limits of stability

    change from baseline to 4 weeks

  • limits of stability

    change from 4 weeks to 8 weeks

Study Arms (2)

home exercise program

EXPERIMENTAL

• The exercise group will follow a home exercise protocol for eight weeks: that involves standing on one foot, walking, and doing wall squats.

Other: home exercise program

non exercise group

ACTIVE COMPARATOR

• The non-exercise group will continue with their usual life style

Other: non exercise program

Interventions

Subjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks.

home exercise program

continue usual lifestyle

non exercise group

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range: 45-64 years.
  • Able to walk and move independently

You may not qualify if:

  • Lower limb injury in the last 3 months.
  • Lower limb surgery in the last 6 months.
  • Current involvement in a rehabilitation program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Study Officials

  • Gurinder Bains, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 15, 2017

First Posted

May 19, 2017

Study Start

October 31, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations