NCT06295146

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), and a wait list control group (Group 2).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jun 2024Dec 2027

First Submitted

Initial submission to the registry

February 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

February 27, 2024

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline following training

    Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)

  • Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (6 months)

    6 months post training (6 mo assessment for groups 1 and 3; 12 mo assessment for group 2)

  • Wheelchair Skills Test Questionnaire (WST-Q) improvement from baseline (12 months)

    1 year

  • Goal Attainment Scale (GAS) improvement from baseline (post training)

    Post-training (2 mo assessment for groups 1 and 3; 8 mo assessment for group 2)

  • Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF) Mobility improvement (6 months)

    6 months

  • +5 more secondary outcomes

Study Arms (3)

Active intervention (intervention A)

EXPERIMENTAL

Active intervention (intervention A) which will include training through peer coaching

Other: Intervention A: 1-on-1 wheelchair skills training by a peer coach

Waitlist control group

ACTIVE COMPARATOR

Waitlist control group that will receive the same intervention A but at 6 months

Other: Intervention A: 1-on-1 wheelchair skills training by a peer coach

Self-study intervention

ACTIVE COMPARATOR

Self-study intervention with review of educational materials

Other: Intervention B: Training via educational videos

Interventions

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.

Active intervention (intervention A)Waitlist control group

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.

Self-study intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

ParaplegiaSpinal Cord InjuriesQuadriplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lynn Worobey, PhD/DPT

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Tempest, BS

CONTACT

Debbie Harrington, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 6, 2024

Study Start

June 25, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations