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. 2024 Oct 18;24:401. doi: 10.1186/s12883-024-03858-y

Table 1.

Outcome measures

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.