Pilot Study on the Safety and Effectiveness of an Electrically Powered Orthopedic Device to Improve Walking and Balance in Adults with Gait Disorders

What this Trial Is About

Researchers are investigating the effectiveness and safety of a new electrically powered orthopedic exercise device designed to help people with gait disorders, which are common in older adults due to aging and related declines in nervous, cardiovascular, respiratory, or musculoskeletal systems. Gait problems can reduce quality of life by increasing fall risk and limiting daily activities. This pilot study aims to assess changes in walking and balance when using the device to understand its potential clinical benefits. The study involves 30 participants who will undergo several assessments of their walking and balance abilities without wearing the device, followed by four adaptation sessions where they wear the device and walk short distances to get used to its operation and fit. After these sessions, participants will be tested again while wearing the device using the same walking and balance tests. The device settings will be personalized to each participant to minimize discomfort or anxiety. A satisfaction survey will be completed at the end of the study. Participants will take part in various tests including the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale both before and after adapting to the device. These assessments will be supervised by medical professionals in a rehabilitation setting, with rest periods provided between tests. Researchers will measure gait parameters such as step count, cadence, walking speed, distance, and stride length. The study will also collect feedback on how usable and satisfactory the device is. The total study participation spans the initial screening, adaptation sessions, and final evaluation within a few weeks.

Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders