Aim 1 |
Safety, tolerability, and feasibility |
Metrics include safety (rate of adverse events [e.g., fall incidence, hypotensive episode, skin integrity]), tolerability (visual analog scale of 1 [not tolerable] – 10 [tolerable]), and feasibility (treatment completion rate: proportion of patients completing at least 90% of the inpatient RGT sessions). |
Aim 2 |
Gait speed via 10-Meter Walk Test (10MWT) |
Our primary outcome, the 10MWT, assesses gait speed over a short duration. Gait speed (m/s) is correlated with ability to mobilize in the community, capacity to perform activities of daily living, and risk of falls, re-hospitalization, and cognitive decline [21].Score changes >0.16 m/s exceed the MCID [22]. Normal gait speed for adults older than 50 years is >1.27 m/s [23]. |
Functional Ambulation Category (FAC) |
The FAC assesses functional ambulation in patients undergoing rehabilitation and has excellent reliability, good predictive validity, and good responsiveness in patients with stroke [24]. Scores range from 0 (unable to walk) to 5 (independent walking anywhere). After 4 weeks of rehabilitation, FAC scores ≥4 predict community ambulation at 6 months with 100% sensitivity and 78% specificity [25]. |
6-Minute Walk Test (6MWT) |
The 6MWT assesses distance walked over 6 minutes as a sub-maximal test of walking capacity. With excellent test-retest reliability (ICC = 0.99) [26] for people with stroke, the established MCID is 34.4 meters [27]. |
Gait quality |
Gait quality will be measured weekly on a visual analog scale from 1 (“my walking is the worst it has ever been”) to 10 (“my walking is just like before my stroke”). |
Modified Rankin Scale (mRS) |
The mRS measures the degree of disability or dependence in the daily activities of people who have had a stroke. The mRS is an ordinal scale with 6 categories ranging from 0 (no symptoms) to 5 (complete physical dependence) [28]. |
Stroke Rehabilitation Assessment of Movement (STREAM) |
The STREAM [28,29] assesses upper and lower limb motor function along with basic mobility in people with stroke and has a very high inter-rater reliability (ICC = 0.96) [30]. MCID values have been established for the upper extremity (2.2 points), lower extremity (1.9 points), and mobility (4.8 points) subscales [31]. |
Continuity Assessment Record and Evaluation (CARE) |
The Section GG CARE Tool is utilized in post-acute care settings for tracking progress across the continuum of care and is conducted at admission and discharge. The CARE addresses self-care (GG0130, 8 items) and functional mobility (GG0170, 17 items). Scores for each item range from 1 (dependent) to 6 (independent). Total scores for the CARE have strong positive correlations with total scores for the Functional Independence Measure [24]. |
5 Times Sit-to-Stand Test (5TSST) |
The 5TSST assesses lower extremity strength and is an indicator of postural control [32]. People with stroke who score >15 seconds are considered at risk for falls [33, 34]. Normal scores for individuals aged 60-80 years range from 11.4 to 12.7 seconds [35]. The 5TSST has demonstrated excellent test-retest reliability (ICC = 0.95) with an established MDC95of 2.3 seconds [36]. |
Berg Balance Scale (BBS) |
The BBS [37] is a 14-item objective measure that assesses static balance and fall risk in adults. With excellent reliability (ICC = 0.95) [38], the BBS has a large responsiveness for acute stroke (effect size = 0.85) [39] and a minimal detectable change of 6.9 points [40]. Scores <45/56 indicate a risk of falling [41]. |
Pain |
Pain will be assessed following each RGT and UC session using a pain visual analog scale [19], as per standard of care in our inpatient rehabilitation hospital. |
Stroke Impact Scale – 16 (SIS-16) |
The SIS-16 assesses 4 dimensions of health-related QOLs specific to people who have had a stroke. Included subscales assess strength, hand function, mobility, and activities of daily living via 5-point Likert scales [42, 43]. |
Aim 3 |
Cost analysis |
Cost-effectiveness will be assessed by comparing RGT to UC relative to walking function as measured by the MCID of the 10MWT (>0.16 m/s). Cost-benefit will be assessed by comparing RGT to UC relative to fall incidence. |