Effects of Intensive Body Weight Support Treadmill Training (BWSTT) on Neurohormonal Profile and Functional Outcomes in Subacute Stroke Patients: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Neuroendocrine Profile: Plasma Cortisol Level
研究概览
简要总结
The purpose of this study is to evaluate the impact of intensive Body Weight Support Treadmill Training (BWSTT) on the neuroendocrine system and functional recovery in patients during the subacute phase of ischemic stroke. The investigators aim to determine how structured locomotor training influences the concentration of selected neurohormones and how these changes correlate with improvements in gait and balance. Participants undergo a 3-week intensive rehabilitation program, with assessments performed before and after the intervention to identify biomarkers of recovery.
详细描述
A randomized controlled trial (RCT) was conducted to compare the effects of Body Weight Support Treadmill Training (BWSTT) with traditional overground gait training in patients in the subacute phase of ischemic stroke (2-6 weeks post-stroke). Both groups received 15 gait training sessions (5 sessions per week over 3 weeks) in addition to standard neurorehabilitation. Assessments were performed at baseline and after completion of the 3-week program.
The analysis included:
Biochemical parameters: plasma concentrations of cortisol, melatonin, serotonin, and β-endorphins.
Functional variables: static and dynamic balance, mobility, risk of falls, gait speed, and walking capacity.
Quality of life and the degree of disability/independence.
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)
盲法说明
Due to the nature of the physical therapy intervention, participants and therapists could not be blinded. However, the laboratory staff analyzing biochemical samples and the statistician were blinded to group allocation to ensure objective outcome assessment.
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever unilateral ischemic stroke (right or left hemisphere) confirmed by MRI.
- •Subacute phase of stroke (between 2 and 6 weeks post-incident).
- •Age between 45 and 85 years.
- •Balance: A score of ≥ 21/56 points on the Berg Balance Scale (BBS), ensuring the ability to safely maintain a standing position.
- •Mobility: Baseline gait speed ≥ 0.4 m/s (classified as Limited Community Ambulation).
- •Permitted Aids: Use of orthopedic aids (quadripod, cane, walker) and foot stabilization (e.g., Thera-Band).
- •Physical Capacity: Ability to complete the 6-Minute Walk Test (6MWT) without requiring rest breaks.
- •Cognitive Status: MMSE score ≥ 23 (ensuring the ability to understand and follow instructions).
- •Informed, written patient consent provided in accordance with the Declaration of Helsinki.
排除标准
- •Neurological Profile: Hemorrhagic stroke, recurrent stroke, bilateral stroke, or lesions localized in the cerebellum or brainstem.
- •Functional Dependence: Requirement for constant, hands-on physical assistance from third parties to maintain upright gait (despite the use of orthopedic aids).
- •Medical Contraindications: Cardiorespiratory instability (e.g., uncontrolled hypertension, cardiac arrhythmia), recent fractures, or advanced degenerative joint changes preventing safe verticalization.
- •Pharmacological Interference: Use of Selective Serotonin Reuptake Inhibitors (SSRIs) or other medications significantly affecting the neuroendocrine profile (e.g., hormone replacement therapy, corticosteroids).
- •Communication & Cognitive Barriers: Global or profound sensory aphasia, or severe cognitive impairment (MMSE < 23) preventing effective cooperation.
- •Co-morbidities: Any neurologic (e.g., Parkinson's disease, multiple sclerosis), orthopedic, rheumatological, or internal conditions (including active malignancy, severe systemic infections, or untreated metabolic disorders) that could interfere with the intervention's safety or the integrity of hormonal and functional assays.
- •Consent: Withdrawal of consent or lack of voluntary, written consent to participate in the study.
研究组 & 干预措施
Experimental Group (BWSTT)
Participants in this group received 15 sessions (30 minutes each, 5 days/week for 3 weeks) of Body Weight Support Treadmill Training (BWSTT) using the Parestand device with 25% dynamic body-weight unloading. In addition, all participants received a standardized 90-minute morning neurorehabilitation session (NDT-Bobath/PNF).
干预措施: Body Weight Support Treadmill Training (BWSTT) (Device)
Control Group (Overground Training)
Participants in this group received 15 sessions (30 minutes each, 5 days/week for 3 weeks) of traditional overground gait training matched in duration and intensity (40-85% HRR) to the experimental group. In addition, all participants received the same standardized 90-minute morning neurorehabilitation session (NDT-Bobath/PNF).
干预措施: Overground Training (Behavioral)
结局指标
主要结局
Neuroendocrine Profile: Plasma Cortisol Level
时间窗: Baseline samples were collected on Day 2 of admission, and post-intervention samples were collected during the final week (Day 21), following 15 sessions of training
Blood samples (5ml) were collected between 08:00-08:30 AM from the antecubital vein into K3EDTA vacuum tubes with aprotinin (50 KIU/ml). Samples were centrifuged (10 min, 3500 rpm), partitioned into Eppendorf tubes, and stored at -80°C. Only hemolysis- and lipemia-free plasma was analyzed. Concentrations were determined via ELISA using a BioTek ELx808IU reader. Methodology: Kits utilized: Cortisol ELISA (DiaMetra, Italy). Normal range: 60-230 ng/ml. All procedures followed manufacturer protocols via Gen5 software. This is part of the exploratory assessment of the neurohormonal response to Body Weight Support Treadmill Training (BWSTT). Unit of Measure: Nanograms per milliliter
Functional Walking Capacity (6-Minute Walk Test)
时间窗: Baseline (Day 2) and Post-intervention (Day 21, after 15 training sessions).
The 6MWT assesses functional exercise capacity and endurance. Patients are instructed to walk as far as possible for 6 minutes on a flat, hard surface at a self-selected pace. Clinical Significance: A change of 37 to 66 meters is considered a clinically significant improvement for stroke patients (Perera S. 2006). The distance covered reflects the patient's cardiovascular and muscular adaptation to physical effort in daily activities. Higher values (greater distance in meters) indicate better functional exercise capacity.
Short-distance Gait Speed (10-Meter Walk Test)
时间窗: Baseline (Day 2) and Post-intervention (Day 21, after 15 training sessions).
Measurement of walking speed at a comfortable pace. Patients walk a total of 14 meters, while the time is recorded for the central 10 meters to allow for acceleration and deceleration. Calculation: The time taken to walk the central 10 meters is recorded, and the average speed is calculated in meters per second (m/s). Clinical Significance: A change in gait speed of 0.15 - 0.25 m/s (Flansbjer U.B 2005) is considered a clinically significant improvement for stroke patients. Some studies suggest that in the subacute phase, an improvement of 0.08 - 0.14 m/s (Perera S. 2006) may already be clinically meaningful. It is assumed that achieving a speed of 0.8 m/s provides the patient with satisfactory independence (Perry J. 1995), and above 0.8 m/s - independence (Ada L. 2003). Higher values indicate better functional mobility. Unit of Measure: Meters per second
Neuroendocrine Profile: Plasma Serotonin Level
时间窗: Baseline samples were collected on Day 2 of admission, and post-intervention samples were collected during the final week (Day 21), following 15 sessions of training
Blood samples (5ml) were collected between 08:00-08:30 AM from the antecubital vein into K3EDTA vacuum tubes with aprotinin (50 KIU/ml). Samples were centrifuged (10 min, 3500 rpm), partitioned into Eppendorf tubes, and stored at -80°C. Only hemolysis- and lipemia-free plasma was analyzed. Concentrations were determined via ELISA using a BioTek ELx808IU reader. Methodology: Kits utilized: Serotonin ELISA (DLD Diagnostika, Germany). Normal range: 70-270 ng/ml. All procedures followed manufacturer protocols via Gen5 software. This is part of the exploratory assessment of the neurohormonal response to Body Weight Support Treadmill Training (BWSTT). Unit of Measure: Nanograms per milliliter
Neuroendocrine Profile: Plasma Melatonin Level
时间窗: Baseline samples were collected on Day 2 of admission, and post-intervention samples were collected during the final week (Day 21), following 15 sessions of training
Blood samples (5ml) were collected between 08:00-08:30 AM from the antecubital vein into K3EDTA vacuum tubes with aprotinin (50 KIU/ml). Samples were centrifuged (10 min, 3500 rpm), partitioned into Eppendorf tubes, and stored at -80°C. Only hemolysis- and lipemia-free plasma was analyzed. Concentrations were determined via ELISA using a BioTek ELx808IU reader. Methodology: Kits utilized: Human Melatonin ELISA (BT Lab, China). Normal range: 10-40 ng/l. All procedures followed manufacturer protocols via Gen5 software. This is part of the exploratory assessment of the neurohormonal response to Body Weight Support Treadmill Training (BWSTT). Unit of Measure: Nanograms per liter
Neuroendocrine Profile: Plasma β-endorphin Level
时间窗: Baseline samples were collected on Day 2 of admission, and post-intervention samples were collected during the final week (Day 21), following 15 sessions of training
Blood samples (5ml) were collected between 08:00-08:30 AM from the antecubital vein into K3EDTA vacuum tubes with aprotinin (50 KIU/ml). Samples were centrifuged (10 min, 3500 rpm), partitioned into Eppendorf tubes, and stored at -80°C. Only hemolysis- and lipemia-free plasma was analyzed. Concentrations were determined via ELISA using a BioTek ELx808IU reader. Methodology: Kits utilized: Human β-endorphin ELISA (BT Lab, China). Normal range: 10-50 ng/l. All procedures followed manufacturer protocols via Gen5 software. This is part of the exploratory assessment of the neurohormonal response to Body Weight Support Treadmill Training (BWSTT). Unit of Measure: Nanograms per liter
次要结局
- Static and Dynamic Balance (Berg Balance Scale - BBS)(Baseline (Day 2) and Post-intervention (Day 21).)
- Functional Mobility and Fall Risk (Timed Up and Go - TUG).(Baseline (Day 2) and Post-intervention (Day 21).)
- Quality of Life: Ferrans and Powers Quality of Life Index (QLI) - Stroke Version III (Polish version)(Baseline (Day 2) and Post-intervention (Day 21).)
- Functional Independence: Barthel Index (ADL)(Baseline (Day 2) and Post-intervention (Day 21).)
- Social Participation and Functional Status(6, 12, 18 months, 5 years, and 10 years post-intervention.)
- Long-term Safety and Health Outcomes (Recurrent Stroke and Mortality)(6, 12, 18 months, 5 years, and 10 years post-intervention.)
- Life Satisfaction: Satisfaction with Life Scale (SWLS)(Baseline (Day 2) and Post-intervention (Day 21).)
- Disability Level: Modified Rankin Scale (mRS)(Baseline (Day 2) and Post-intervention (Day 21).)
研究者
Beata Stach
PhD, Assistant Professor
Jagiellonian University