Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 12:31 AM
Study NCT ID:
NCT06294834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKILL
Brief Summary:
The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently.
Detailed Description:
A randomized, single-blinded, two-period cross-over study design for Groups 1 and 2 will be used. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After enrollment for Groups 1 and 2 is completed, Group 3 participants will be enrolled.
Group 1 will receive the active intervention (intervention A) which will include a two-part training in wheelchair skills. For Part 1, they will review approximately 4 hours of educational videos on how to complete and teach wheelchair skills. For Part 2 they will complete a practice-feedback loop with a remote trainer providing asynchronous feedback. Group 3 will mirror Group 1 but complete only Part 1 of the training. Group 2 will receive the control intervention (intervention B) participants will review approximately 4 hours of educational videos. Participants will have 8 weeks to complete either training program. Both groups will then complete follow-up at 2 and 6 months. Following this, participants will cross over to receive the other intervention (Group 1 and 3 will receive intervention B, Group 2 will receive intervention A) and complete follow-up at 8 and 12 months.
Additionally, rehabilitation professionals who are not therapists will be able to access the training through a structured self-study (Group 4). This group will receive access to both trainings with follow-up at 2 and 6 months.
Group 1 will receive the active intervention (intervention A) which will include a two-part training in wheelchair skills. For Part 1, they will review approximately 4 hours of educational videos on how to complete and teach wheelchair skills. For Part 2 they will complete a practice-feedback loop with a remote trainer providing asynchronous feedback. Group 3 will mirror Group 1 but complete only Part 1 of the training. Group 2 will receive the control intervention (intervention B) participants will review approximately 4 hours of educational videos. Participants will have 8 weeks to complete either training program. Both groups will then complete follow-up at 2 and 6 months. Following this, participants will cross over to receive the other intervention (Group 1 and 3 will receive intervention B, Group 2 will receive intervention A) and complete follow-up at 8 and 12 months.
Additionally, rehabilitation professionals who are not therapists will be able to access the training through a structured self-study (Group 4). This group will receive access to both trainings with follow-up at 2 and 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 90SIMS0010 | OTHER_GRANT | NIDILRR | View |