- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02569138
Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear
6 décembre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
13
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3C5
- Biomechanics Lab, Wilfrid Laurier University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- have appropriate footwear
Exclusion Criteria:
- any vestibular, neurological, or muscular injuries that may affect their balance or gait
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: Insole (Control)
usual insole found in footwear, non-modified insole
|
regular shoe insert between the foot sole and base of the footwear
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change of Stability Margin from Week 0
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of Falls
Délai: Recorded twice a week during the 12 week study duration
|
Recorded twice a week during the 12 week study duration
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Elizabeth McLeod, BSc, Wilfrid Laurier University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2015
Achèvement primaire (Réel)
1 avril 2016
Achèvement de l'étude (Réel)
1 juin 2016
Dates d'inscription aux études
Première soumission
30 septembre 2015
Première soumission répondant aux critères de contrôle qualité
5 octobre 2015
Première publication (Estimation)
6 octobre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 décembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 décembre 2016
Dernière vérification
1 décembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- EM_FFP
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .