Feasibility study of randomized supplemental therapeutic lower limb exercise in acute stroke rehabilitation

Objectives: To determine the feasibility and tolerability of supplemental therapeutic lower limb walking exercise in acute stroke rehabilitation with either a robotic or conventional therapy intervention. If the pilot study is feasible and tolerable, we will collect secondary outcome measures to determine power and sample size for a larger clinical trial. Methods: Participants - Acute stroke patients with unilateral hemiparesis ≥ 18 years of age with a MAS ≤3. Intervention - Patients participated in conventional therapy that will assure compliance with mandates of time and staff (3 hours of one-to-one therapy). Participants received supplemental therapy of either 30 minutes of conventional (control) or 30 minutes of Lokomat® training (intervention) aimed at walking up to 5 days per week. Their overall involvement in the study is dependent on their length of stay. Main Outcome Measures - tolerability; Length of Stay (LOS); Functional Independence Measure (FIM); Functional Ambulation Category (FAC); Passive Range of Motion (PROM); Modified Ashworth Scale (MAS); 10 Meter walk test (10MWT); 2-Minute walk test (2MWT); 5 Times sit-to-stand (5x-STS) and Modified Borg Rating of Perceived Exertion Scale (RPE) for therapist. Results: 10 patients currently enrolled (2: Lokomat; 8: Conventional). Most of the participants were male (n=7) and the average age was 56. Seventy percent of the patients had ischemic strokes with left sided paresis (80%). The following adverse events were reported: skin irritation; technical problems with the Lokomat and scheduling conflicts. Based on the interim data analysis, the average FIM gain total was 25.4 points for the conventional group and 27.0 points for the Lokomat group. The average FIM efficiency was 1.2 for the conventional group and 1.3 for the Lokomat group. Conclusions: These preliminary findings provide a proof-of-concept demonstration that an additional lower limb exercise in combination with mandated multi-disciplinary therapies in acute stroke population is feasible.