Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills: A Feasibility Study
7 octobre 2021 mis à jour par: Ben Mortenson, University of British Columbia
Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel, community-based, client-centred intervention where skills training is incorporated into social activities that users want to perform.
The trainer also offers problem solving strategies to help manage environmental barriers and to promote social participation.
This intervention is different from customary scooter training in that customary training is often very limited and focuses on learning discrete skills outside of the user's normal environment.
The purpose of this study is to explore the feasibility of conducting a mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which will evaluate the efficacy of SCOOT.
We anticipate that the feasibility outcomes will be strong enough to support the conduct of a subsequent multi-site trial with a sufficient sample size to enable us to quantify definitive outcomes such as adverse events (e.g., injuries and abandonment).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
22
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
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 2G9
- GF Strong Rehabilitation Center
-
-
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
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- English Speaking
- Aged 60 or above
- Has acquired a scooter in the last month prior to enrollment in the study
Exclusion Criteria:
- Has a cognitive impairment that will prevent the individual from providing consent and reliably completing the study questionnaires
- Reside in a nursing home
- Plan to move outside Vancouver within the next year
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: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: SCOOT Immediate
This group will receive SCOOT immediately
|
An occupational therapist trained by the principal investigator will perform 1.5 hour SCOOT sessions with participants one to two times a week over a period of 6 weeks.
SCOOT will provide instruction and practice for performing scooter skills (i.e., instruction on driving, basic and advanced scooter skills) that are embedded in self-selected activities that participants want to perform using their scooters.
|
|
Autre: SCOOT Delayed
This group will receive SCOOT after 6 weeks
|
An occupational therapist trained by the principal investigator will perform 1.5 hour SCOOT sessions with participants one to two times a week over a period of 6 weeks.
SCOOT will provide instruction and practice for performing scooter skills (i.e., instruction on driving, basic and advanced scooter skills) that are embedded in self-selected activities that participants want to perform using their scooters.
Participants will begin the SCOOT intervention after a six week delay.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in scooter skills capacity
Délai: Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
|
The WST-ScQ measures the participant's subjective scooter skills (capacity), and inquires on the frequency the skill is performed, and whether or not improvement of the skill is a personal goal.
|
Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Wheelchair Skills Test for Scooters (WST-Sc)
Délai: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
The WST-Sc consists of 29 skills that are scored by an examiner from 0 to 2, where 0 = unsafe or unable, 1 = safe with difficulty, and 2 = safe without difficulty
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
|
Wheelchair Skills Test for Scooters - Questionnaire (WST-ScQ) (performance and confidence)
Délai: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
The WST-ScQ measures the participant's subjective scooter skills, and inquires on the participant's scooter skill confidence, frequency the skill is performed (performance), and whether or not improvement of the skill is a personal goal.
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
|
Scooter Skills Confidence Questionnaire
Délai: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
This measure evaluates the participant's confidence in managing their social environment
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
|
Wheeled Mobility Outcome Questionnaire
Délai: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
This measure evaluates indoor and outdoor participation levels associated with wheeled mobility provision by using an 11 point scale (0 = completely unsatisfied to 10 = completely satisfied).
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
|
Life Space Assessment (LSA) Questionnaire
Délai: Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
The LSA measures participants' frequency and independence of mobility in increasingly larger life spaces over the past month.
|
Baseline, at 6 weeks, 12 weeks, 6 months, and 1 year
|
|
Scooter Use and Incidents
Délai: Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
|
Participants will be asked to keep a diary of any scooter-related adverse events, including the following: tips or falls from the scooter, injuries to self, accidental contact with others, injuries to others, and damage to property.
Participants will be asked to record the number of hours per day that they use their scooters.
|
Baseline, 6 weeks, 12 weeks, 6 months, and 1 Year
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Montreal Cognitive Assessment Test
Délai: Baseline
|
This assessment is used to detect any mild cognitive impairments
|
Baseline
|
|
Late Life Functioning and Disability measure - Computer Assisted Testing (LLFDI - CAT)
Délai: Baseline
|
The LLFDI-CAT is a computerized program that measures the participant's physical function.
Drawing from a bank of 141 items, CAT continues until a standard error of 3 is obtained for the domain score, or a maximum of ten items has been administered.
|
Baseline
|
|
Hearing Handicap Inventory for the Elderly (HHIE) Screening version
Délai: Baseline
|
The HHIE will be used to evaluate the participants' hearing abilities.
|
Baseline
|
|
Scooter Physical Accessibility of Participant Home and Community
Délai: Baseline
|
This measure involves 14 yes/no questions inquiring about the accessibility of the participants' physical environment in their home and community.
|
Baseline
|
|
Trail Making B Test
Délai: Baseline
|
This task is used to measure the participants' visual attention and task switching abilities, which is related to on road driving
|
Baseline
|
|
Snellen Eye Test
Délai: Baseline
|
Baseline
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ben Mortenson, University of British Columbia
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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 (Réel)
1 mars 2016
Achèvement primaire (Réel)
1 décembre 2020
Achèvement de l'étude (Réel)
1 octobre 2021
Dates d'inscription aux études
Première soumission
23 février 2016
Première soumission répondant aux critères de contrôle qualité
25 février 2016
Première publication (Estimation)
2 mars 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 octobre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 octobre 2021
Dernière vérification
1 octobre 2021
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- H15-01921
- F15-00959 (Autre subvention/numéro de financement: Canadian Institutes of Health Research)
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 .