Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation

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.

• Anti-Gravity Treadmill (Device), also known as BTL R-FORCE: A treadmill system that enables walking training with partial body weight support (up to 100%) by creating positive pressure in a sealed chamber housing the participant. This technology makes it possible to begin restorative walking training as early as possible after a stroke, without the risk of overloading weakened muscle groups or causing falls.
• High-Intensity Electromagnetic Stimulation (Device), also known as Repetitive Peripheral Magnetic Stimulation, BTL-6000 Super Inductive System: A therapeutic device utilizing high-intensity pulsed electromagnetic fields that can penetrate deep-seated tissues to produce an antispastic effect. The treatment is applied directly to the spastic leg muscles and their antagonists to reduce muscle tone and support motor recovery.
• Standard Rehabilitation (Procedure): Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.

Primary outcomes

• Change from Baseline in Rivermead Mobility Index (RMI) [Baseline (admission) and Day 14 (discharge)]: The RMI assesses functional mobility (gait, balance, and transfers). The score ranges from 0 to 15, where higher scores indicate better mobility.
• Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) score [Baseline (admission) and Day 14 (discharge)]: The NIHSS is used to measure the severity of neurological deficits. The score ranges from 0 to 42, where higher scores indicate a worse neurological status.
• Change from Baseline in Functional Independence Measure (FIM) [Baseline (admission) and Day 14 (discharge)]: The FIM assesses the level of a patient's physical and cognitive disability and their functional independence in daily activities. The score ranges from 18 to 126, where higher scores indicate greater functional independence.
• Change from Baseline in Berg Balance Scale (BBS) [Baseline (admission) and Day 14 (discharge)]: The BBS is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. The score ranges from 0 to 56, where higher scores indicate better balance.

Secondary outcomes

• Change from Baseline in modified Rankin Scale (mRS) [Baseline (admission) and Day 14 (discharge)]: The mRS is used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke. The score ranges from 0 to 6, where lower scores indicate less disability.
• Change from Baseline in Rehabilitation Routing Scale (SRM) [Baseline (admission) and Day 14 (discharge)]: The SRM assesses disability and determines the appropriate rehabilitation pathway or setting. The score ranges from 0 to 6, where lower scores indicate clinical improvement (reduction in burden).
• Change from Baseline in modified Ashworth Scale (mAS) [Baseline (admission) and Day 14 (discharge)]: The mAS is used to assess the muscle tone and measure the increase in muscle spasticity. The score ranges from 0 to 4, where lower scores indicate a reduction in spasticity.
• Change from Baseline in Hauser Ambulation Index (HAI) [Baseline (admission) and Day 14 (discharge)]: The HAI is a rating scale used to evaluate mobility and walking ability, focusing on the time and degree of assistance required. The score ranges from 0 to 9, where higher scores indicate worse walking status.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* verified diagnosis of ischemic or hemorrhagic stroke according to neuroimaging data (computed tomography or magnetic resonance imaging;
* age 18;
* Rankin Scale score of 3-4 upon admission;
* ability to obtain informed consent.

Exclusion Criteria:

\- rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, contraindications to physical exercise.