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Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear
6 december 2016 bijgewerkt door: Dr. Stephen Perry, Wilfrid Laurier University
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
13
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3C5
- Biomechanics Lab, Wilfrid Laurier University
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
65 jaar en ouder (Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- have appropriate footwear
Exclusion Criteria:
- any vestibular, neurological, or muscular injuries that may affect their balance or gait
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Insole (Experimental)
specially designed insole, featuring hard and thin design, modified insole
|
hard and thin shoe insert between the foot sole and base of the footwear
|
|
Experimenteel: Insole (Control)
usual insole found in footwear, non-modified insole
|
regular shoe insert between the foot sole and base of the footwear
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change of Stability Margin from Week 0
Tijdsspanne: 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
|
At 0, 6, and 12 Weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of Falls
Tijdsspanne: Recorded twice a week during the 12 week study duration
|
Recorded twice a week during the 12 week study duration
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elizabeth McLeod, BSc, Wilfrid Laurier University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2015
Primaire voltooiing (Werkelijk)
1 april 2016
Studie voltooiing (Werkelijk)
1 juni 2016
Studieregistratiedata
Eerst ingediend
30 september 2015
Eerst ingediend dat voldeed aan de QC-criteria
5 oktober 2015
Eerst geplaatst (Schatting)
6 oktober 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
7 december 2016
Laatste update ingediend die voldeed aan QC-criteria
6 december 2016
Laatst geverifieerd
1 december 2016
Meer informatie
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .