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

NCT ID: NCT02569138

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-06-30

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.

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.

Conditions

Accidental Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Insole (Experimental)

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

Group Type: EXPERIMENTAL

Modified Insole

Intervention Type: DEVICE

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

Insole (Control)

usual insole found in footwear, non-modified insole

Group Type: EXPERIMENTAL

Non-Modified Insole

Intervention Type: DEVICE

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

Interventions

Modified Insole

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

Intervention Type: DEVICE

Non-Modified Insole

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• have appropriate footwear

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wilfrid Laurier University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stephen Perry

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth McLeod, BSc

Role: PRINCIPAL_INVESTIGATOR

Wilfrid Laurier University

Locations

Biomechanics Lab, Wilfrid Laurier University

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

EM_FFP

Identifier Type: -

Identifier Source: org_study_id