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Accidental FallsNCT02569138

Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear

A study testing Modified Insole and Non-Modified Insole in people with Accidental Falls, run by Wilfrid Laurier University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Accidental Falls
What is being tested?
Modified Insole and Non-Modified Insole
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteCanada
Study dates
Oct 2015to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • have appropriate footwear

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Biomechanics Lab, Wilfrid Laurier University

    Waterloo, Ontario, N2L 3C5

Other trials in Canada

About this study

Official title: Investigating Long Term Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear

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.

Read the detailed description

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. Those who are defined as healthy older adults as per the initial screening questionnaire will be asked to complete additional screening tests during a scheduled testing session including sensory testing, balance testing, and cognitive testing using monofilaments, the Berg Balance Scale, and the Montreal Cognitive Assessment tool, respectively. Participants will also be examined for degree of hallux valgus using the Manchester Scale, since moderate to severe hallux valgus has displayed balance deficits for older adults. Those participants that complete all tests and display acceptable age range scores as define by the test guidelines will be randomly selected to either be in an intervention group (20 participants) or a control group (10 participants). All participants will be fitted for custom insoles that are hard and thin. These insoles will not affect their habitual ankle position or habitual stance in any way. These insoles will be designed to mechanically support the foot within the shoe, but mostly to provide as much somatosensory feedback as possible detected through mechanoreceptors under the skin on the plantar sole of the foot. Participants in the intervention group will be required to wear these insoles in their shoes for the full 12 week intervention. One pair of each participant's shoes of both groups will be chosen by the primary investigator to be worn for the entire duration of the 12 week intervention for at least 8 hours per day. These shoes will be chosen if eligible within a footwear assessment form and previous footwear recommendations from previous literature for older adults. Each testing session will be held in a common room located within close vicinity of the participant's residence. A camcorder will be used to record participant movement during each trial located directly in front of the participant. Foam markers will then be fastened on to the participant's body using tape at 7 locations to allow for body movement analysis in correspondence with the video recording. Flat and thin pressure sensor insoles that will not cause any discomfort to the participant will be place into each shoe to detect the pressure forces and distribution under the feet. Once equipment has been set up in the room and with the participant, participants will complete various tasks including quiet standing, one-legged stance, and walking up and down a ramp while unexpectedly terminating gait (10 seconds), performing a cognitive task while walking up and down a ramp (10 seconds), and normal walking (10 seconds). Participants will be provided with 12 postcards outlining general questions regarding insole and footwear comfort, hours of wear, and record of falls. Participants will be required to complete these cards twice a week and mail/return the cards to Wilfrid Laurier University. The cards will be pre-printed with address on the front and a sticky tab to seal the card once completed.

Being tested
Modified Insole, Non-Modified Insole
Keywords
Balance, Footwear, Shoes, Falls

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified InsoleDevice

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

  • Non-Modified InsoleDevice

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

Study groups in NCT02569138
Study groupRoleWhat they receive
Insole (Experimental)Experimentalspecially designed insole, featuring hard and thin design, modified insole
Receives: Device: Modified Insole
Insole (Control)Experimentalusual insole found in footwear, non-modified insole
Receives: Device: Non-Modified Insole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 0, 6, and 12 Weeks

Secondary outcomes (1)
  1. Number of Falls

    Measured: Recorded twice a week during the 12 week study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionApr 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569138
Sponsor's protocol ID
EM_FFP
Status last verified
Dec 2016
First submitted
30 Sep 2015
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Modified Insole and Non-Modified Insole in people with Accidental Falls, run by Wilfrid Laurier University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Stability Margin from Week 0 (time frame: At 0, 6, and 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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