Efficacy of Feedback-Controlled Robotics-Assisted Treadmill Exercise to Improve Cardiovascular Fitness Early After Stroke: A Randomized Controlled Pilot Trial

BACKGROUND AND PURPOSE: Cardiovascular fitness is greatly reduced after stroke. Although individuals with mild to moderate impairments benefit from conventional cardiovascular exercise interventions, there is a lack of effective approaches for persons with severely impaired physical function. This randomized controlled pilot trial investigated efficacy and feasibility of feedback-controlled robotics-assisted treadmill exercise (FC-RATE) for cardiovascular rehabilitation in persons with severe impairments early after stroke. METHODS: Twenty individuals (age 61 ± 11 years; 52 ± 31 days poststroke) with severe motor limitations (Functional Ambulation Classification 0-2) were recruited for FC-RATE or conventional robotics-assisted treadmill exercise (RATE) (4 weeks, 3 × 30-minute sessions/wk). Outcome measures focused on peak cardiopulmonary performance parameters, training intensity, and feasibility, with examiners blinded to allocation. RESULTS: All 14 allocated participants (70% of recruited) completed the intervention (7/group, withdrawals unrelated to intervention), without serious adverse events occurring. Cardiovascular fitness increased significantly in both groups, with peak oxygen uptake increasing from 14.6 to 17.7 mL · kg(−1) · min(−1) (+17.8%) after 4 weeks (45.8%-55.7% of predicted maximal aerobic capacity; time effect P = 0.01; no group-time interaction). Training intensity (% heart rate reserve) was significantly higher for FC-RATE (40% ± 3%) than for conventional RATE (14% ± 2%) (P = 0.001). DISCUSSION AND CONCLUSIONS: Substantive overall increases in the main cardiopulmonary performance parameters were observed, but there were no significant between-group differences when comparing FC-RATE and conventional RATE. Feedback-controlled robotics-assisted treadmill exercise significantly increased exercise intensity, but recommended intensity levels for cardiovascular training were not consistently achieved. Future research should focus on appropriate algorithms within advanced robotic systems to promote optimal cardiovascular stress. Video abstract available for more insights from the authors (Supplemental Digital Content 1, http://links.lww.com/JNPT/A107).