An interventional study of Anti-Gravity Treadmill and High-Intensity Electromagnetic Stimulation in Stroke, Muscle Spasticity and Stroke Rehabilitation, sponsored by BTL Industries Ltd.. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 105 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →BTL Industries Ltd. is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 13, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, to physical exercise.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: Standard Rehabilitation
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 · Device: High-Intensity Electromagnetic Stimulation · Procedure: Standard Rehabilitation
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
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.
Also known as: BTL R-FORCE
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.
Also known as: Repetitive Peripheral Magnetic Stimulation, BTL-6000 Super Inductive System
Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (admission) and Day 14 (discharge)
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline (admission) and Day 14 (discharge)
Plan to share: Yes — Anonymized individual participant data will be shared as supporting information files directly with the journal publication.
No publications or documents are linked to this record.
Ran from Jan 2026 to primary completion in May 2026, 4 months.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 4 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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