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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06295146
Other study ID # STUDY23050075
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date December 30, 2027

Study information

Verified date February 2024
Source University of Pittsburgh
Contact Lee Tempest, BS
Phone 412-232-9326
Email tempestml@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), wait list control group (Group 2), and structured self-study (Group 3).


Description:

For peer coaches: Coaches will complete the following measures pre and post training: - Demographic questionnaire - Self-Efficacy on Assessing, Training, and Spotting (SEATS) - Feedback survey Prior to coaching trainees, coaches will undergo three training programs as follows: - Virtual training through zoom on peer mentoring - Research ethics training - Wheelchair skills training It will be verified that peer coaches possess the needed skills by administering the SEATS following training. A score of 5 (completely confident) for each training item will be required to advance to the peer coaching sessions. For peer coaching, coaches will lead six 1:1 virtual zoom meetings with each trainee they are matched with. Sessions may include goal setting, review of progress, instruction, and "homework" of prescribed content for trainees to review. For each training session coaches will complete a session log. For trainees: Baseline questionnaires will include: - Demographic questionnaire - Wheelchair setup questionnaire - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) (Group 1,3 only) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Online Learning Readiness Scale (OLRS) - Moorong Self-Efficacy Scale (MSES) - Referral Source - Wheelchair Skills Training Questionnaire - Wheelchair skills training outside of study Group Specific Activities Groups 1 and 2 will complete intervention A following baseline and 6-month assessments, respectively. Group 3 will complete intervention B. Participants in all groups will select what goals are important to them. They are not required to complete training in all skills, only to have at least 5 skills with relevant training goals. Intervention A Trainees will engage in 1:1 virtual zoom meetings facilitated by the study team scheduled weekly for 6 sessions with the opportunity for 2 makeup sessions. Sessions may include goal setting, review of progress, instruction, and "homework" of prescribed content for trainees to review. Participants may upload videos of themselves completing skills through Qualtrics to get feedback. Skills targeted by the intervention - 1. opening/closing doors 2. picking up an object from the ground 3. getting over a gap 4. getting over a threshold 5. up a low curb 6. down a low curb 7. up a high curb 8. down a high curb 9. performing a stationary wheelie 10. up a steep incline 11. down a steep incline 12. getting up stairs 13. getting down stairs 14. uneven transfers 15. floor-to-chair transfer 16. folding and unfolding wheelchair Intervention B Intervention B will be a series of educational videos that participants review and then are encouraged to practice the skills. Participants will have access to the materials for 8 weeks. Group 3 will have access to approximately 3 hours of wheelchair skills video training content. Actual viewing time will depend upon the individual's training goal. While they will receive a weekly reminder about practicing, there is no prescribed frequency for how often they should be practicing the skills in the videos. All participants will complete 2-month follow-up. This will include the following questionnaires: Baseline questionnaires will include: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) - groups 1 and 3 only - Feedback Survey - groups 1 and 3 only - Wheelchair skills training outside of study All participants will complete 6-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Wheelchair skills training outside of study Groups 2 will then cross-over to complete intervention A. All participants will complete 8-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair skills training outside of study survey - Wheelchair Skills Test Questionnaire (WST-Q) - Goal Attainment Scale (GAS) - group 2 only - Feedback Survey - group 2 only - Wheelchair skills training outside of study All participants will complete 12-month follow-up. This will include the following questionnaires: - Wheelchair setup questionnaire - Wheelchair Skills Test Questionnaire (WST-Q) - Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility - Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities - Life Space Assessment (LSA) - Wheelchair skills training outside of study Follow-up windows will be within approximately 2 weeks before/after the follow-up date. Participants will be asked to select two preferred methods of contact for follow-up reminders that will be sent between timepoints. Spotters are required for trainee participation in the study. Prior to the start of the study, spotters will be required to watch a series of training videos about safe spotting.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 132
Est. completion date December 30, 2027
Est. primary completion date December 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Coaches: - At least 18 years old - Non-progressive SCI - Able to speak and read English - Reside in the community - Independently use a manual wheelchair for at least 50% of mobility Coaches with paraplegia: - Able to complete all skills targeted by the intervention, except stair ascent, (WST-Q item scores 2) independently. Coaches with tetraplegia: - Able to complete all skills targeted by the intervention with or without assistance Trainees: - At least 18 years old - Non-progressive SCI - Able to speak and read English - Reside in the community - Independently use a manual wheelchair for 50% of mobility - Access to an Internet-ready device with video capabilities. - Access to a spotter for practicing wheelchair skills - Desire training for at least 5 of the 16 skills targeted by the training program Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Intervention A: 1-on-1 wheelchair skills training by a peer coach
Trainees will engage in 1:1 virtual zoom meetings facilitated by the study team scheduled weekly for 6 sessions with the opportunity for 2 makeup sessions. Sessions will last approximately 30 minutes and may include goal setting, review of progress, instruction, and "homework" of prescribed content for trainees to review. Participants may upload videos of themselves completing skills through Qualtrics to get feedback.
Intervention B: Training via educational videos
Intervention B will be a series of educational videos that participants review and then are encouraged to the practice the skills. Participants will have access to the materials for 8 weeks. Group 3 will have access to approximately 3 hours of wheelchair skills video training content. Actual viewing time will depend upon the individual's training goal. While they will receive a weekly reminder about practicing, there is no prescribed frequency for how often they should be practicing the skills in the videos.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Outcome

Type Measure Description Time frame Safety issue
Primary Capacity, confidence, and performance of wheelchair skills will improve following training Compare the results of the Wheelchair Skills Test Questionnaire (WST-Q) between groups.
The WST-Q is a self report measure of capacity (ability to complete), confidence, and performance (frequency of completing) wheelchair skills. The WST-Q will measured for each of 16 skills targeted in the training and a total score for each domain will be calculated.
6 months
Secondary Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training Compare the results of the WST-Q taken after training to the beginning of study. Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)
Secondary Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months) Compare the results of the WST-Q taken 6 months after training to the beginning of study. 6 months post training (6 mo assessment for groups 1 and 3; 12 mo assessment for group 2)
Secondary Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months) Compare the results of the WST-Q taken 12 months after the beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos. 1 year
Secondary Goal Attainment Scale (GAS) improvement from baseline (post training) Compare the results of the GAS taken post training to results at beginning of study.
For GAS, the wheelchair trainer and trainee will set specific, measurable, attainable, realistic, and time related individual goals. The goals are weighted for importance (0=not at all important, to 3=very important) and difficulty (0=not at all difficult, to 3=very difficult). The wheelchair skill is performed and rated. Possible performance level scores: +2 (much more than expected), +1 (more than expected), 0 expected level, -1 (less than expected), or -2 (much less than expected).
Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)
Secondary Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months) Compare the results of the CHART taken at 6 months to results at beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos.
The CHART is designed as an interview tool, which can be administered face-to-face or by telephone. CHART produces an index of handicap. It is possible to score more than 100 on most of the subscales, however a maximum of 100 points has been allowed, indicating no handicap in that dimension. Scoring takes into account: physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency.
6 months
Secondary Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year) Compare the results of the CHART taken at 1 year to results at beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos. 1 year
Secondary Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months) Compare the results of the WhOM taken at 6 months to results at beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos.
The WhOM is a client-centred measure of wheelchair and seating system intervention.The WhOM is a two part questionnaire which can be administered by a therapist in under 30 minutes, focused on participation outcomes as identified by the participants.
Participants identify their participation outcome goals (i.e. specific things that they want to do and achieve) at home and in the community, and they then rate the importance (Imp) of the goals and satisfaction (Sat) with their performance in reaching their goals. Imp and Sat are rated (0-10) for each identified activity. Sat x Imp score (0-100) for each activity is the product of the two values. Mean Sat and mean Sat x Imp scores are the means of the respective activity scores.
6 months
Secondary Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year) Compare the results of the WhOM taken at 1 year to results at beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos. 1 year
Secondary Life Space Assessment (LSA) improvement from baseline (6 months) Compare the results of the LSA taken at 6 months to results at beginning of study. Group 1 will have received peer coaching, group 2 is the control group, and group 3 will have completed self-study using videos.
The overall score for each life-space level and the total score are calculated by summing the scores. The total score ranges from 0 ("totally bed-bound") to 120 ("traveling out of town every day without assistance"). The LSA is positively scored, with higher scores indicating a larger life space.
6 months
Secondary Life Space Assessment (LSA) improvement from baseline (1 year) Compare the results of the LSA taken at 1 year to results at beginning of study. Group 1 will have received peer coaching 6 months prior, group 2 will have received peer coaching most recently, and group 3 will have completed self-study using videos. 1 year
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