StrokeNCT07698639
Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation
A study testing Anti-Gravity Treadmill, High-Intensity Electromagnetic Stimulation and Standard Rehabilitation in people with Stroke and Muscle Spasticity, run by BTL Industries Ltd. at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Muscle Spasticity, Stroke Rehabilitation
- What is being tested?
- Anti-Gravity Treadmill, High-Intensity Electromagnetic Stimulation and Standard Rehabilitation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, contraindications to physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Stroke, Muscle Spasticity, Stroke Rehabilitation
- Being tested
- Anti-Gravity Treadmill, High-Intensity Electromagnetic Stimulation, Standard Rehabilitation
- Keywords
- post-stroke rehabilitation, anti-gravity treadmill, functional recovery, high-intensity electromagnetic stimulation
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Gravity TreadmillDevice
Also called 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 StimulationDevice
Also called 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 RehabilitationProcedure or surgery
Rehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill | Experimental | 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. Receives: Device: Anti-Gravity Treadmill; Procedure: Standard Rehabilitation |
| Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES | Experimental | 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. Receives: Device: Anti-Gravity Treadmill; Device: High-Intensity Electromagnetic Stimulation; Procedure: Standard Rehabilitation |
| Control Arm 3: Standard rehabilitation only | Active comparator | 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. Receives: Procedure: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (admission) and Day 14 (discharge)
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (admission) and Day 14 (discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start15 Jan 2026
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698639
- Sponsor's protocol ID
- Protocol No. 256
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data will be shared as supporting information files directly with the journal publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Post-Stroke Rehabilitation Using an Anti-Gravity Treadmill and High-Intensity Electromagnetic Stimulation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07698639
- Acronym / sponsor ID
- Protocol No. 256
- Conditions
- Stroke, Muscle Spasticity, Stroke Rehabilitation
- Keywords
- post-stroke rehabilitation, anti-gravity treadmill, functional recovery, high-intensity electromagnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill | Experimental | Device: Anti-Gravity Treadmill, Procedure: Standard RehabilitationParticipants 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. |
| Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES | Experimental | Device: Anti-Gravity Treadmill, Device: High-Intensity Electromagnetic Stimulation, Procedure: Standard RehabilitationParticipants 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. |
| Control Arm 3: Standard rehabilitation only | Active comparator | Procedure: Standard RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, contraindications to physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Gravity TreadmillAlso: BTL R-FORCEA 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. | Device | Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill, Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES |
| High-Intensity Electromagnetic StimulationAlso: Repetitive Peripheral Magnetic Stimulation, BTL-6000 Super Inductive SystemA 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. | Device | Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES |
| Standard RehabilitationRehabilitation consisting of daily physical therapy (limb movement training, balance, and walking exercises), occupational therapy, speech therapy as indicated, and neuropsychological sessions. | Procedure or surgery | Control Arm 3: Standard rehabilitation only, Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill, Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES |
Primary outcome
Change from Baseline in Rivermead Mobility Index (RMI)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Change from Baseline in modified Rankin Scale (mRS)
Time frame: Baseline (admission) and Day 14 (discharge)
Change from Baseline in Rehabilitation Routing Scale (SRM)
Time frame: Baseline (admission) and Day 14 (discharge)
Change from Baseline in modified Ashworth Scale (mAS)
Time frame: Baseline (admission) and Day 14 (discharge)
Change from Baseline in Hauser Ambulation Index (HAI)
Time frame: Baseline (admission) and Day 14 (discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data will be shared as supporting information files directly with the journal publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Gravity Treadmill, High-Intensity Electromagnetic Stimulation and Standard Rehabilitation in people with Stroke and Muscle Spasticity, run by BTL Industries Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Rivermead Mobility Index (RMI) (time frame: Baseline (admission) and Day 14 (discharge)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.