- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06294834
Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users (SKILL)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15219
- University of Pittsburgh / Rehab Neural Engineering Labs
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Practicing rehabilitation professional whose client population includes wheelchair users.
- Willing and able to attempt practicing wheelchair skills
- Access to a spotter(s)
- Access to an Internet-ready device with video capabilities.
- Speaks English
Exclusion Criteria:
1) Confident in teaching (Self-Efficacy on Assessing, Training, and Spotting [SEATS] item score = 5) and able to complete (WST-Q capacity item score = 2) >50% of skills targeted by the training intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group 1: therapists
Group 1 will receive the active intervention (intervention A) of remote wheelchair skills training.
They will cross-over to receive the control intervention (intervention B) of education on wheelchair provision at 6 months.
|
Clinicians will review a suite of training videos in a prescribed order that discuss motor learning principles, safe spotting, and how to complete 15 intermediate and advanced skills:
Participants will practice of wheelchair skills paired with remote feedback.
Participants will be reminded to practice once per week.
The participant will practice any number of the 15 skills for a self-selected duration.
Following each practice session, the participant will upload video(s) of the skills practiced and a session log, indicating any difficulties they encountered.
The remote trainer will then review the video-recordings and reply to the participant with feedback.
Participants will be provided with access to web-based wheelchair provision education modules.
When the content is viewed will be self-selected by participants.
Participants will be asked to complete a feedback survey at the end of the modules.
Participants will receive weekly reminders to complete the intervention until a feedback survey completed.
|
|
Other: Group 2
Group 2 will complete the control intervention (intervention B) of education on wheelchair provision.
They will cross-over to receive the active intervention (intervention A) of remote wheelchair skills training at 6 months.
|
Clinicians will review a suite of training videos in a prescribed order that discuss motor learning principles, safe spotting, and how to complete 15 intermediate and advanced skills:
Participants will practice of wheelchair skills paired with remote feedback.
Participants will be reminded to practice once per week.
The participant will practice any number of the 15 skills for a self-selected duration.
Following each practice session, the participant will upload video(s) of the skills practiced and a session log, indicating any difficulties they encountered.
The remote trainer will then review the video-recordings and reply to the participant with feedback.
Participants will be provided with access to web-based wheelchair provision education modules.
When the content is viewed will be self-selected by participants.
Participants will be asked to complete a feedback survey at the end of the modules.
Participants will receive weekly reminders to complete the intervention until a feedback survey completed.
|
|
Other: Group 3
Groups 3 will mirror Group 1 but for intervention A will only complete Part 1 of the training and then be cued weekly to practice.
|
Clinicians will review a suite of training videos in a prescribed order that discuss motor learning principles, safe spotting, and how to complete 15 intermediate and advanced skills:
Participants will be provided with access to web-based wheelchair provision education modules.
When the content is viewed will be self-selected by participants.
Participants will be asked to complete a feedback survey at the end of the modules.
Participants will receive weekly reminders to complete the intervention until a feedback survey completed.
|
|
Other: Group 4: rehab professionals, not therapists
Group 4 will mirror Group 3 but receive access to both interventions at the same time.
|
Clinicians will review a suite of training videos in a prescribed order that discuss motor learning principles, safe spotting, and how to complete 15 intermediate and advanced skills:
Participants will be provided with access to web-based wheelchair provision education modules.
When the content is viewed will be self-selected by participants.
Participants will be asked to complete a feedback survey at the end of the modules.
Participants will receive weekly reminders to complete the intervention until a feedback survey completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Wheelchair Skills Test Questionnaire (WST-Q) score
Time Frame: baseline vs. 2 months
|
Clinician capacity and confidence to complete wheelchair skills, as measured by wheelchair skills test questionnaire (WST-Q), will improve following training (Group 1,3) compared to the active control group (Group 2).
The WST-Q includes values from 0-3 for each of Capacity, Confidence, and Performance.
These three scores will be averaged.
A higher value indicates a better outcome.
|
baseline vs. 2 months
|
|
Change in Self-Efficacy on Assessing, Training, and Spotting (SEATS) score
Time Frame: baseline vs. 2 months
|
Clinician confidence to provide wheelchair skills training, as measured by the Self-Efficacy on Assessing, Training, and Spotting (SEATS), will improve following training (Group 1,3) compared to the active control group (Group 2).
The SEATS evaluation rates Assessing, Training, and Spotting, on scales from 0-5 for each skill.
The values will be combined and averaged to assess progress over time.
A higher score indicates improvement.
|
baseline vs. 2 months
|
|
Change in number of wheelchair users trained
Time Frame: baseline vs. 6 months
|
Clinician training of wheelchair users will increase in quantity (number of wheelchair users trained, duration of training) in the six months following training (Group 1,3) compared to the active control group (Group 2).
|
baseline vs. 6 months
|
|
Change in quality of wheelchair skills trained
Time Frame: baseline vs. 6 months
|
Clinician training of wheelchair users will increase in quality (number of wheelchair skills trained, capacity of trainees) in the year following training (Group 1,3) compared to the active control group (Group 2).
|
baseline vs. 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in rehab professional Wheelchair Skills Test Questionnaire (WST-Q) score
Time Frame: baseline vs. 2 months, 6 months, and 1 year (Group 1,3 only) following training
|
Rehabilitation professional capacity and confidence to complete wheelchair skills, as measured by wheelchair skills test questionnaire (WST-Q), will improve following training.
The WST-Q includes values from 0-3 for each of Capacity, Confidence, and Performance.
These three scores will be averaged.
A higher value indicates a better outcome.
|
baseline vs. 2 months, 6 months, and 1 year (Group 1,3 only) following training
|
|
Change in rehab professional Self-Efficacy on Assessing, Training, and Spotting (SEATS) score
Time Frame: baseline vs. 2 months, 6 months, and 1 year (Group 1,3 only) following training
|
Rehabilitation professional confidence to provide wheelchair skills training, as measured by the Self-Efficacy on Assessing, Training, and Spotting (SEATS), will improve following training.
The SEATS evaluation rates Assessing, Training, and Spotting, on scales from 0-5 for each skill.
The values will be combined and averaged to assess progress over time.
A higher score indicates improvement.
|
baseline vs. 2 months, 6 months, and 1 year (Group 1,3 only) following training
|
|
Change in rehab professional quantity of wheelchair users trained
Time Frame: baseline vs. 6 months, and 1 year (Group 1,3 only) following training
|
Rehabilitation professional training of wheelchair users will increase in quantity (number of wheelchair users trained, duration of training) following training.
|
baseline vs. 6 months, and 1 year (Group 1,3 only) following training
|
|
Change in rehab professional quality of wheelchair training
Time Frame: baseline vs. 6 months, and 1 year (Group 1,3 only) following training
|
Rehabilitation professional training of wheelchair users will increase in quality (number of wheelchair skills trained, capacity of trainees) in the year following training.
|
baseline vs. 6 months, and 1 year (Group 1,3 only) following training
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynn Worobey, PhD/DPT, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22010071
- 90SIMS0010 (Other Grant/Funding Number: NIDILRR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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