Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation

Overview

The goal of this clinical trial is to learn if adding new technologies to standard therapy helps people recover after a stroke. It looks at adults aged 18 to 74 who recently had a stroke and need help with moving and walking. The main questions the study aims to answer are: Does adding anti-gravity treadmill training to standard physical therapy improve balance and walking ability? Does adding high-intensity electromagnetic therapy to the treadmill program further help lower muscle stiffness and improve movement? Are these combined exercise treatments safe for the participants? Researchers will compare three groups of participants to see which combination works best: Group 1 receives standard physical therapy and anti-gravity treadmill training. Group 2 receives standard physical therapy, anti-gravity treadmill training, and electromagnetic therapy. Group 3 receives standard physical therapy only. Participants will: Complete standard physical and daily living therapy for three to four hours a day, five days a week. Exercise on a special treadmill that uses air pressure to support their body weight (Groups 1 and 2 only). Receive a 15-minute electromagnetic stimulation treatment on their leg muscles 10 times over two weeks (Group 2 only). Take movement, balance, and walking tests at the start and at the end of the two-week program.

Background and Rationale Stroke is a leading cause of long-term disability and death worldwide. Many people who survive a stroke experience severe weakness in their limbs (62%) and difficulties with balance or walking (46%). Starting intensive, multi-disciplinary rehabilitation early is crucial to help patients maximize their recovery and regain independence. Traditional treadmill training is a powerful tool to restore walking ability, but it is often unsafe or impossible for patients who have lost significant muscle strength in their legs. This study evaluates a comprehensive rehabilitation program designed to overcome these limitations by combining two modern physical therapy technologies: an anti-gravity treadmill and high-intensity electromagnetic stimulation (HIES). The Technologies Being Tested The Anti-Gravity Treadmill (BTL's R-FORCE): This device uses a sealed chamber with positive air pressure to gently lift the participant, supporting up to 100% of their body weight. This allows individuals to practice walking very early in their recovery without overloading weak muscles or risking a fall. HIES (BTL-6000 Super Inductive System): This technology sends pulsed electromagnetic fields deep into neuromuscular tissues. It is used to safely lower muscle stiffness (spasticity) and improve general joint movement. While both tools are expanding in clinical use individually, this trial directly examines if integrating them into a single protocol provides a superior cumulative benefit for walking recovery and spasticity reduction. Study Design and Participant Groups This prospective, randomized, comparative clinical trial included 105 participants hospitalized in the acute or early recovery phase of a stroke at Samara City Clinical Hospital. All participants presented with a baseline modified Rankin Scale score of 3 to 4, indicating moderate to severe disability requiring daily assistance. Participants were randomly allocated in an equal 1:1:1 ratio into one of three parallel groups (35 individuals per group): Group 1 (Treadmill Group): Participants received standard inpatient rehabilitation combined with specialized anti-gravity treadmill training. Group 2 (Combined Technology Group): Participants received standard inpatient rehabilitation, anti-gravity treadmill training, and HIES. Group 3 (Control Group): Participants received the standard inpatient rehabilitation protocol only. What Participation Involved All three groups underwent a highly active 14-day rehabilitation program. Every participant completed approximately 3 to 4 hours of standard multidisciplinary therapy per day, 5 days a week, which included physical therapy, occupational therapy, and speech therapy as needed. Participants in Groups 1 and 2 added tailored walking sessions on the anti-gravity treadmill to their daily routine. Participants in Group 2 additionally received 10 sessions of HIES (5 times per week for 15 minutes per session) targeting the lower back spine and the spastic leg muscles. Clinical and functional assessments were performed for all participants at the time of admission and again at discharge (Day 14). To ensure objective tracking, the assessments were conducted by independent medical experts who were strictly blinded to which treatment group the participants belonged to. The trial carefully monitored changes in overall neurological health, balance, walking ability, muscle stiffness, and general functional independence in daily activities.