Clinical trial NCT06295146: Virtual Peer Coaching in Manual Wheelchair Skills
Official title: Improving Manual Wheelchair Skills Through Remote Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wheelchair
Paraplegia
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: For trainees, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 (N=40 per group) we will enroll participants into Group 3 ( N=40 per group).
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Capacity, confidence, and performance of wheelchair skills will improve following training
timeFrame: 6 months
Secondary outcomes:
measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training
timeFrame: Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)
measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months)
timeFrame: 6 months post training (6 mo assessment for groups 1 and 3; 12 mo assessment for group 2)
measure: Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months)
timeFrame: 1 year
measure: Goal Attainment Scale (GAS) improvement from baseline (post training)
timeFrame: Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)
measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months)
timeFrame: 6 months
measure: Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (1 year)
timeFrame: 1 year
measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (6 months)
timeFrame: 6 months
measure: Wheelchair Outcome Measure (WhOM) Satisfaction with Participation in Meaningful Activities after baseline (1 year)
timeFrame: 1 year
measure: Life Space Assessment (LSA) improvement from baseline (6 months)
timeFrame: 6 months
measure: Life Space Assessment (LSA) improvement from baseline (1 year)
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Lynn Worobey, PhD/DPT
role: PRINCIPAL_INVESTIGATOR
References: