- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02569138
Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear
6. desember 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
13
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3C5
- Biomechanics Lab, Wilfrid Laurier University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- have appropriate footwear
Exclusion Criteria:
- any vestibular, neurological, or muscular injuries that may affect their balance or gait
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: Insole (Control)
usual insole found in footwear, non-modified insole
|
regular shoe insert between the foot sole and base of the footwear
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of Stability Margin from Week 0
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Falls
Tidsramme: Recorded twice a week during the 12 week study duration
|
Recorded twice a week during the 12 week study duration
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Elizabeth McLeod, BSc, Wilfrid Laurier University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2015
Primær fullføring (Faktiske)
1. april 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
30. september 2015
Først innsendt som oppfylte QC-kriteriene
5. oktober 2015
Først lagt ut (Anslag)
6. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .