[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06295146":3,"trial-entities:NCT06295146":132,"trial-summary:NCT06295146":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":100,"locations":103,"central_contacts":122,"overall_officials":126,"references":130,"see_also_links":131},"NCT06295146","STUDY23050075","Virtual Peer Coaching in Manual Wheelchair Skills","Improving Manual Wheelchair Skills Through Remote Training","RECRUITING","2027-12-30","2026-04","2026-04-14","2024-06-25","University of Pittsburgh","OTHER",false,"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), and a wait list control group (Group 2).","For peer coaches:\n\nCoaches will complete the following measures:\n\n* Demographic questionnaire (pre-training)\n* Self-Efficacy on Assessing, Training, and Spotting (SEATS) (pre- and post-training)\n* Feedback survey (post peer coaching)\n\nPrior to coaching trainees, coaches will undergo three training programs as follows:\n\n* Virtual training through zoom on peer mentoring\n* Research ethics training\n* Wheelchair skills training\n\nIt 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.\n\nFor 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.\n\nFor trainees:\n\nBaseline questionnaires will include:\n\n* Demographic questionnaire\n* Wheelchair setup questionnaire\n* Wheelchair Skills Test Questionnaire (WST-Q)\n* Goal Attainment Scale (GAS) (Group 1,3 only)\n* Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility\n* Life Space Assessment (LSA)\n* Online Learning Readiness Scale (OLRS)\n* Moorong Self-Efficacy Scale (MSES)\n* Referral Source\n* Wheelchair Skills Training Questionnaire (WST-Q)\n* Wheelchair skills training outside of study\n\nGroup Specific Activities\n\nGroups 1 and 2 will complete intervention A following baseline and 6-month assessments, respectively. They are not required to complete training in all skills, only to have at least 5 skills with relevant training goals.\n\nIntervention 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.\n\nSkills targeted by the intervention -\n\n1. opening\u002Fclosing doors\n2. picking up an object from the ground\n3. getting over a gap\n4. getting over a threshold\n5. up a low curb\n6. down a low curb\n7. up a high curb\n8. down a high curb\n9. performing a stationary wheelie\n10. up a steep incline\n11. down a steep incline\n12. getting up stairs\n13. getting down stairs\n14. uneven transfers\n15. floor-to-chair transfer\n16. folding and unfolding wheelchair\n\nAll participants will complete 2-month follow-up. This will include the following questionnaires:\n\nBaseline questionnaires will include:\n\n* Wheelchair setup questionnaire\n* Wheelchair skills training outside of study survey\n* Wheelchair Skills Test Questionnaire (WST-Q)\n* Goal Attainment Scale (GAS) - group 1\n* Feedback Survey - group 1 only\n\nAll participants will complete 6-month follow-up. This will include the following questionnaires:\n\n* Wheelchair setup questionnaire\n* Wheelchair skills training outside of study survey\n* Wheelchair Skills Test Questionnaire (WST-Q)\n* Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility\n* Life Space Assessment (LSA)\n\nGroups 2 will then cross-over to complete the intervention.\n\nAll participants will complete 8-month follow-up. This will include the following questionnaires:\n\n* Wheelchair setup questionnaire\n* Wheelchair skills training outside of study survey\n* Wheelchair Skills Test Questionnaire (WST-Q)\n* Goal Attainment Scale (GAS) - group 2 only\n* Feedback Survey - group 2 only\n\nAll participants will complete 12-month follow-up. This will include the following questionnaires:\n\n* Wheelchair setup questionnaire\n* Wheelchair Skills Test Questionnaire (WST-Q)\n* Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility\n* Life Space Assessment (LSA)\n* Wheelchair skills training outside of study\n\nFollow-up windows will be within approximately 2 weeks before\u002Fafter 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.\n\nSpotters 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.",[19,20,21,22,23],"Wheelchair","Paraplegia","Spinal Cord Injury","Tetraplegia\u002FTetraparesis","Spinal Cord Injuries (SCI)",[],"INTERVENTIONAL","BASIC_SCIENCE",[28],"NA",{"count":30,"type":31},132,"ESTIMATED",[33,39],{"type":14,"name":34,"description":35,"armGroupLabels":36},"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.",[37,38],"Active intervention (intervention A)","Waitlist control group",{"type":14,"name":40,"description":41,"armGroupLabels":42},"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.",[43],"Self-study intervention",[45],{"measure":46,"description":47,"timeFrame":48},"Capacity, confidence, and performance of wheelchair skills will improve following training","Compare the results of the Wheelchair Skills Test Questionnaire (WST-Q) between groups.\n\nThe 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",[50,54,58,62,65,68,71,74,77,80],{"measure":51,"description":52,"timeFrame":53},"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)",{"measure":55,"description":56,"timeFrame":57},"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)",{"measure":59,"description":60,"timeFrame":61},"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",{"measure":63,"description":64,"timeFrame":53},"Goal Attainment Scale (GAS) improvement from baseline (post training)","Compare the results of the GAS taken post training to results at beginning of study.\n\nFor 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).",{"measure":66,"description":67,"timeFrame":48},"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.\n\nThe 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.",{"measure":69,"description":70,"timeFrame":61},"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.",{"measure":72,"description":73,"timeFrame":48},"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.\n\nThe 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.\n\nParticipants 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.",{"measure":75,"description":76,"timeFrame":61},"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.",{"measure":78,"description":79,"timeFrame":48},"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.\n\nThe 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.",{"measure":81,"description":82,"timeFrame":61},"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.","ALL","18 Years",null,{"inclusion":87,"exclusion":97,"raw_text":99},[88,89,90,91,92,88,89,90,91,93,94,95,96],"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","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",[98],"none","Inclusion Criteria:\n\nCoaches:\n\n* At least 18 years old\n* Non-progressive SCI\n* Able to speak and read English\n* Reside in the community\n* Independently use a manual wheelchair for at least 50% of mobility\n\nCoaches with paraplegia:\n\n\\- Able to complete all skills targeted by the intervention, except stair ascent, (WST-Q item scores 2) independently.\n\nCoaches with tetraplegia:\n\n\\- Able to complete all skills targeted by the intervention with or without assistance\n\nTrainees:\n\n* At least 18 years old\n* Non-progressive SCI\n* Able to speak and read English\n* Reside in the community\n* Independently use a manual wheelchair for 50% of mobility\n* Access to an Internet-ready device with video capabilities.\n* Access to a spotter for practicing wheelchair skills\n* Desire training for at least 5 of the 16 skills targeted by the training program\n\nExclusion Criteria:\n\n* none",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":13,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":119},"Pittsburgh","Pennsylvania","15219","United States",[110,115],{"name":111,"role":112,"phone":113,"email":114},"Lee Tempest, BS","CONTACT","412-232-9326","tempestml@upmc.edu",{"name":116,"role":112,"phone":117,"email":118},"Debbie Harrington, BS","4123370372","debbie.harrington@pitt.edu",{"lat":120,"lon":121},40.44062,-79.99589,[123,124],{"name":111,"role":112,"phone":113,"email":114},{"name":116,"role":112,"phone":125,"email":118},"412-383-1355",[127],{"name":128,"affiliation":13,"role":129},"Lynn Worobey, PhD\u002FDPT","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":133,"biomarkers":134},[21],[],{"nct_id":4,"found":136,"summary":137,"prompt_version":146},true,{"design":138,"status":139,"heading":6,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This interventional study plans to enroll 132 participants into different training groups, including one with remote feedback and a waitlist control group.","completed","This study is looking at how well remote training helps people improve their manual wheelchair skills. You would either receive one-on-one virtual coaching sessions with a peer coach (Intervention A) or access to educational videos (Intervention B). The study aims to see if your ability, confidence, and performance with wheelchair skills improve after training, measured at 6 months. To join as a coach, you must be at least 18, use a manual wheelchair independently, and have a non-progressive spinal cord injury (SCI). The current status of this study is unclear, and it plans to enroll 132 participants.","The primary outcomes of the study will be measured at 6 months after training.",97,"If you are a trainee in Intervention A, you would have 6 weekly virtual Zoom meetings, each lasting about 30 minutes, with the option for 2 makeup sessions. If you are in Intervention B, you would have access to about 3 hours of educational videos for 8 weeks.","Not stated in the trial record.",[],"v2"]