Effectiveness and Usability of Robot and Digital Technology Rehabilitation Compared to Traditional Therapy in Stroke Patients 18 Years and Older

What this Trial Is About

Researchers are evaluating rehabilitation methods for patients who have had a stroke within the past six months. The study aims to compare rehabilitation using Robot and Allied Digital Technologies RADTs with traditional rehabilitation, focusing on the recovery of daily living activities. This multicenter randomized controlled trial seeks to determine if rehabilitation with RADTs is not worse than traditional methods, while also exploring potential benefits, usability, and economic sustainability. Participants will be randomly assigned to one of two groups. The experimental group receives rehabilitation with RADTs, involving devices for upper and lower limb motor skills, gait, balance, and cognitive abilities, supervised by two physical therapists managing 4 to 6 patients. The control group undergoes traditional one-on-one rehabilitation targeting the same domains without robotic devices. Both groups complete 25 sessions of 45 minutes each, with inpatient treatments held five times a week for five weeks and outpatient treatments three times a week for about eight weeks. Throughout the study, participants will have various assessments including the modified Barthel Index to measure daily living activities, motor and sensory function tests, balance scales, cognitive tests, pain scales, and neurophysiological and biomarker evaluations. Follow-up evaluations will continue monthly for six months after treatment. Data are collected uniformly across centers to assess effectiveness, patient and caregiver acceptance, and economic impact of the rehabilitation methods.

Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients