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| Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation |
| Talaty M, Esquenazi A |
| Journal of Neuroengineering & Rehabilitation 2023 Oct 4;20(134):Epub |
| clinical trial |
| 5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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INTRODUCTION: Practicality of implementation and dosing of supplemental gait training in an acute stroke inpatient rehabilitation setting are not well studied but can have positive impact on outcomes. OBJECTIVES: To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery. DESIGN AND SETTING: Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility. PARTICIPANTS: Thirty acute post-stroke patients with unilateral hemiparesis (>= 18 years of age with a lower limb MAS <= 3). INTERVENTION: Lokomat R or conventional gait training (CGT) in addition to standard mandated therapy time. MAIN OUTCOME MEASURES: Number of therapy sessions; adverse events; functional independence measure (FIM motor); functional ambulation category (FAC); passive range of motion (PROM); modified Ashworth scale (MAS); 5 times sit-to-stand (5x-STS); 10-m walk test (10MWT); 2-min walk test (2MWT) were assessed before (pre) and after training (post). RESULTS: The desired supplemental therapy was implemented during normal care delivery hours and the patients generally tolerated the sessions well. Both groups improved markedly on several measures; the CGT group obtained nearly 45% more supplemental sessions (12.8) than the Lokomat R group (8.9). Both groups showed greater FIM improvement scores (discharge to admission) than those from a reference group receiving no supplemental therapy. An overarching statistical comparison between methods was skewed towards a differential benefit (but not significant) in the Lokomat R group with medium effect sizes. By observation, the robotic group completed a greater number of steps, on average. These results provide some evidence for Lokomat R being a more efficient tool for gait retraining by providing a more optimal therapy "dose". CONCLUSIONS: With careful planning, supplemental therapy was possible with minimal intrusion to schedules and was well tolerated. Participants showed meaningful functional improvement with relatively little supplemental therapy over a relatively short time in study.
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