What Does It Involve?

Study at a Glance:

The objectives for TRAIL-RCT are as follows:

  1. The primary objective is to compare functional mobility (Timed Up and Go, primary clinical outcome) after 4 weeks of TRAIL to a 4-week attention-controlled education program (EDUCATION) in individuals ≤12 months post-stroke;
  2. The secondary objective is to compare the 4-week TRAIL and EDUCATION programs on secondary outcomes of:
    1. Lower extremity strength (30-Second Sit-to Stand test);
    2. Functional balance (Tandem Stand and Functional Reach);
    3. Motor impairment (Virtual Fugl-Meyer Assessment);
    4. Balance self-efficacy (Activities-specific Balance Confidence Scale);
  1. The tertiary objective is to compare the 4-week TRAIL and EDUCATION programs on health economic outcomes:
    1. Health-related quality of life (Stroke Impact Scale, EuroQol-5D-5 Level); and
    2. Health resources and costs (Health Resource Utilization Questionnaire)
  1. The quaternary objective is to evaluate the feasibility of a subsequent larger multisite implementation stepped wedge randomized trial of TRAIL using pre-specified criteria related to process, resources, management, and scientific indicators.

Time Commitment:

Time Commitment
1 Screening & Consent 30 mins = 0.5 hours
2 Technology Set-Up Orientation 30 mins = 0.5 hours
Baseline Virtual Evaluation Part 1 80 mins = ~1.5 hours
3 Baseline Virtual Evaluation Part 2 90 mins = ~1.5 hours
4 Intake Session and Home Assessment 30 mins = 0.5 hours
5 4-week TRAIL or EDUCATION Program 8 x 60-90 mins = 8-12 hours
6 Self-Managed Exercise Sessions or Written Homework *4 x 60-90 mins = 4-6 hours
7 Post-Program Follow-Up 1 Virtual Evaluation (4 weeks after baseline) 90 mins = 1.5 hours
8 Post-Program Follow-Up 2 Virtual Evaluation (3 months after baseline) 90 mins = 1.5 hours
9 Post-Program Follow-Up 3 Virtual Evaluation & Exit Survey (6 months after baseline) 90 mins = 1.5 hours
TOTAL Minimum of ~20.5 – 26 hours
*Participants allocated to TRAIL will be asked to complete at least 1 self-management session per week during the program. The anticipated time commitment for homework in the EDUCATION group is 1-2 hours per week.

As mentioned above, this study involves 5 virtual evaluations. There will be two evaluations sessions at the beginning of the study (i.e., baseline), one evaluation immediately following the completion of your TRAIL or EDUCATION program (4-weeks), and one evaluation at each 3 and 6 months after you’ve completed the program.