Efficacy of Post-Stroke Rehabilitation Using an Anti-Gravity Treadmill and High-Intensity Electromagnetic Stimulation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change from Baseline in Rivermead Mobility Index (RMI)
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •severe cognitive impairment (MoCA < 10),
- •rapidly progressive neurological deficit, unstable cardiovascular or respiratory system condition, contraindications to physical exercise.
研究组 & 干预措施
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.
干预措施: Anti-Gravity Treadmill (Device)
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.
干预措施: Standard Rehabilitation (Procedure)
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.
干预措施: High-Intensity Electromagnetic Stimulation (Device)
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.
干预措施: Standard Rehabilitation (Procedure)
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.
干预措施: Anti-Gravity Treadmill (Device)
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.
干预措施: Standard Rehabilitation (Procedure)
结局指标
主要结局
Change from Baseline in Rivermead Mobility Index (RMI)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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))