P-OT016. The comparison of robotic glove training and conventional training in post-stroke hand impairment patients: A pilot randomized controlled trial protocol

Abstract

Introduction . Rehabilitation in stroke patients is crucial in minimizing the neurological deficit, improving their quality of life and reducing the caretakers’ burden. Post-stroke hand impairment is common and improving hand function is a core element of rehabilitation. For such patients, robotic glove training might be a promising tool. This trial aims to determine the efficacy, safety, feasibility and cost effectiveness of Robotic Glove Training (RGT) compared with Conventional Training (CT) among post-stroke unilateral hand impairment patients. Methods . This is a pilot, randomized, assessor blinded, controlled trial. Adult patients with first onset of stroke with unilateral poststroke hand impairment (Medical Research Council Grading ≤ 3) will be selected. Subjects will be randomized into RGT or CT group in a 1:1 ratio. Both groups also will undergo the usual daily home hand exercises. The endpoints will be measured after 6 weeks of training. Results . For efficacy assessment, hand grip strength; tip, key and palmar pinch strength; and hand motor function will be measured using Hand Dynamometer; Pinch Gauge; Motor Assessment Scale and Fulg Meyer Assessment. For safety assessment, hand spasticity and pain will be assessed using Modified Ashworth Scale and Ministry of Health Pain Scale. For feasibility assessment, adverse event and level of operator difficulty in handling the robotic glove device will be assessed. For cost effectiveness, the average cost per hour of a physiotherapist spend during training will be analyzed. Independent t-test or Mann-Whitney test will be used to compare the two mean scores and a P value of < 0.05 is considered statistically significant. Conclusion . We hypothesized that RGT group will show better improvement in terms of hand grip strength, pinch strength and hand motor function compared to CT group among post- stroke unilateral hand impairment patients. We also expected that RGT will be safe, feasible and cost effective.