Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke Rehabilitation

NCT07698639 | Completed

• 1 other identifier: Protocol No. 256
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Muscle Spasticity; Stroke Rehabilitation

Keywords

post-stroke rehabilitation; anti-gravity treadmill; functional recovery; high-intensity electromagnetic stimulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change from Baseline in modified Rankin Scale (mRS)

  Baseline (admission) and Day 14 (discharge)

• Change from Baseline in Rehabilitation Routing Scale (SRM)

  Baseline (admission) and Day 14 (discharge)

• Change from Baseline in modified Ashworth Scale (mAS)

  Baseline (admission) and Day 14 (discharge)

• Change from Baseline in Hauser Ambulation Index (HAI)

  Baseline (admission) and Day 14 (discharge)

Study Arms (3)

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.

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.

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.

Procedure: Standard Rehabilitation

Interventions

Anti-Gravity Treadmill DEVICE

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

Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill; Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES

High-Intensity Electromagnetic Stimulation DEVICE

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

Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES

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.

Control Arm 3: Standard rehabilitation only; Experimental Arm 1: Standard rehabilitation + Anti-gravity treadmill; Experimental Arm 2: Standard rehabilitation + Anti-gravity treadmill + HIES

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Samara City Clinical Hospital No. 2

Samara, Samara Oblast, 443008, Russia

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2026
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)