NCT02569138

Brief Summary

The purpose of this study is to investigate the long term balance-enhancing effects of insoles that are hard and thin for older adults. Thirty older female adults between the ages of 65-84 years will be recruited for this study. Twenty participants (20) will wear the experimental insole and ten (10) participants will work their usual insole, during a 12 week period. Balance and foot sensitivity testing will take place at 0, 6 and 12 weeks. These tests will involve measurement of body motion and foot pressure in order to evaluate balance control. Additionally, each participant will be asked to return a bi-weekly postcard that will report on footwear wearing patterns and any falls (or fall-related) incidents that have occurred during the 12 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

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

September 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

September 30, 2015

Last Update Submit

December 6, 2016

Conditions

Accidental Falls

Keywords

BalanceFootwearShoesFalls

Outcome Measures

Primary Outcomes (1)

  • Change of Stability Margin from Week 0

    Stability margin is the ability of the individual to maintain their body's balance point within their base of support while walking or performing a balance task

    At 0, 6, and 12 Weeks

Secondary Outcomes (1)

  • Number of Falls

    Recorded twice a week during the 12 week study duration

Study Arms (2)

Insole (Experimental)

EXPERIMENTAL

specially designed insole, featuring hard and thin design, modified insole

Device: Modified Insole

Insole (Control)

EXPERIMENTAL

usual insole found in footwear, non-modified insole

Device: Non-Modified Insole

Interventions

Modified InsoleDEVICE

hard and thin shoe insert between the foot sole and base of the footwear

Insole (Experimental)
Non-Modified InsoleDEVICE

regular shoe insert between the foot sole and base of the footwear

Insole (Control)

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • have appropriate footwear

You may not qualify if:

  • any vestibular, neurological, or muscular injuries that may affect their balance or gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics Lab, Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

Location

Study Officials

  • Elizabeth McLeod, BSc

    Wilfrid Laurier University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 6, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

CA(1)