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

Accidental Falls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569138
• Other study ID #: EM_FFP
• Status: Completed
• Phase: N/A
• First received: September 30, 2015
• Last updated: December 6, 2016
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: Wilfrid Laurier University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• have appropriate footwear

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Device:
• Modified Insole
hard and thin shoe insert between the foot sole and base of the footwear
• Non-Modified Insole
regular shoe insert between the foot sole and base of the footwear

Locations

Country	Name	City	State
Canada	Biomechanics Lab, Wilfrid Laurier University	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Wilfrid Laurier University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Falls		Recorded twice a week during the 12 week study duration	No