Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation

Efficacy of Post-Stroke Rehabilitation Using an Anti-Gravity Treadmill and High-Intensity Electromagnetic Stimulation: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Muscle Spasticity; Stroke Rehabilitation
• Intervention / Treatment: Device: Anti-Gravity Treadmill; Procedure: Standard Rehabilitation; Device: High-Intensity Electromagnetic Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Samara Oblast
    • Samara, Samara Oblast, Russia, 443008
      • Samara City Clinical Hospital No. 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• verified diagnosis of ischemic or hemorrhagic stroke according to neuroimaging data (computed tomography or magnetic resonance imaging;
• age 18 to 74 years;
• Rankin Scale score of 3-4 upon admission;
• ability to obtain informed consent.

Exclusion Criteria:

• severe cognitive impairment (MoCA < 10),
• rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, contraindications to physical exercise.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill; Participants in this arm receive standard rehabilitation combined with specialized anti-gravity treadmill training. Standard Rehabilitation: This protocol consists of daily physical therapy (focusing on limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions. Anti-Gravity Treadmill Training: Participants undergo walking training with partial body weight support. The total combined training amounts to approximately 3 to 4 hours per day, 5 days a week, over a 14-day early rehabilitation period.	Device: Anti-Gravity Treadmill; 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.; Other Names: BTL R-FORCE; Procedure: Standard Rehabilitation; Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.
Experimental: Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES; Participants in this arm receive standard rehabilitation combined with specialized anti-gravity treadmill training and high-intensity electromagnetic stimulation (HIES). Standard Rehabilitation: This protocol consists of daily physical therapy (focusing on limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions. Anti-Gravity Treadmill Training: Participants undergo walking training with partial body weight support.. HIES: Participants receive 10 sessions of HIES delivered 5 times per week (15 minutes per session). The treatment directly targets the spastic leg muscles and their antagonists, including the quadriceps femoris, calf muscles, and the lumbar spine nerve projection zone. The total training amounts to approximately 3 to 4 hours per day, 5 days a week, over a 14-day early rehabilitation period.	Device: Anti-Gravity Treadmill; 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.; Other Names: BTL R-FORCE; Procedure: Standard Rehabilitation; Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.; Device: High-Intensity Electromagnetic Stimulation; 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.; Other Names: Repetitive Peripheral Magnetic Stimulation; BTL-6000 Super Inductive System
Active Comparator: Control Arm 3: Standard rehabilitation only; Participants in this arm receive the standard rehabilitation protocol only. Standard Inpatient Rehabilitation: This protocol follows the current institutional standard care and includes scheduled physical therapy (focusing on limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions. The total training amounts to approximately 3 to 4 hours per day, 5 days a week, over a 14-day early rehabilitation period.	Procedure: Standard Rehabilitation; Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Rivermead Mobility Index (RMI)	The RMI assesses functional mobility (gait, balance, and transfers). The score ranges from 0 to 15, where higher scores indicate better mobility.	Baseline (admission) and Day 14 (discharge)
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) score	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.	Baseline (admission) and Day 14 (discharge)
Change from Baseline in Functional Independence Measure (FIM)	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.	Baseline (admission) and Day 14 (discharge)
Change from Baseline in Berg Balance Scale (BBS)	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.	Baseline (admission) and Day 14 (discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in modified Rankin Scale (mRS)	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.	Baseline (admission) and Day 14 (discharge)
Change from Baseline in Rehabilitation Routing Scale (SRM)	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).	Baseline (admission) and Day 14 (discharge)
Change from Baseline in modified Ashworth Scale (mAS)	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.	Baseline (admission) and Day 14 (discharge)
Change from Baseline in Hauser Ambulation Index (HAI)	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.	Baseline (admission) and Day 14 (discharge)

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): May 31, 2026
• Study Completion (Actual): May 31, 2026

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: functional recovery; post-stroke rehabilitation; anti-gravity treadmill; high-intensity electromagnetic stimulation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Stroke
• Other Study ID Numbers: Protocol No. 256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data will be shared as supporting information files directly with the journal publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No