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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569138
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Stephen Perry, Wilfrid Laurier University

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.

Condition or disease Intervention/treatment Phase
Accidental Falls Device: Modified Insole Device: Non-Modified Insole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating Long Term Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear
Study Start Date : October 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Insole (Experimental)
specially designed insole, featuring hard and thin design, modified insole
Device: Modified Insole
hard and thin shoe insert between the foot sole and base of the footwear

Experimental: Insole (Control)
usual insole found in footwear, non-modified insole
Device: Non-Modified Insole
regular shoe insert between the foot sole and base of the footwear




Primary Outcome Measures :
  1. Change of Stability Margin from Week 0 [ Time Frame: At 0, 6, and 12 Weeks ]
    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


Secondary Outcome Measures :
  1. Number of Falls [ Time Frame: Recorded twice a week during the 12 week study duration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • have appropriate footwear

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569138


Locations
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Canada, Ontario
Biomechanics Lab, Wilfrid Laurier University
Waterloo, Ontario, Canada, N2L 3C5
Sponsors and Collaborators
Wilfrid Laurier University
Investigators
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Principal Investigator: Elizabeth McLeod, BSc Wilfrid Laurier University
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Responsible Party: Dr. Stephen Perry, Professor, Wilfrid Laurier University
ClinicalTrials.gov Identifier: NCT02569138    
Other Study ID Numbers: EM_FFP
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Dr. Stephen Perry, Wilfrid Laurier University:
Balance
Footwear
Shoes
Falls