The Effect of BWSTT on Neuroendocrine Profile and Functional Recovery in Stroke Patients

Effects of Intensive Body Weight Support Treadmill Training (BWSTT) on Neurohormonal Profile and Functional Outcomes in Subacute Stroke Patients: A Randomized Controlled Trial.

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.

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.

Additionally, a long-term follow-up was conducted via telephone interviews at 6, 12, 18 months, and 5 years post-intervention to assess social participation, functional status, and long-term health outcomes (mortality and stroke recurrence). A further 10-year follow-up is planned to evaluate the long-term sustainability of the intervention effects.

Experimental Group (BWSTT): Participants underwent 15 sessions (30 minutes each, 5 days/week for 3 weeks) of Body Weight Support Treadmill Training (BWSTT) using the Parestand device. A constant 25% dynamic body-weight unloading was applied. Training intensity was monitored to maintain 40-85% of Heart Rate Reserve (HRR) and a perceived exertion of < 4 on the Modified Borg Scale (0-10). Sessions included a 3-minute warm-up and cool-down. Physical therapists provided manual facilitation of the pelvis and paretic limb as needed. In the morning (08:00-10:00), all participants received a standardized 90-minute neurorehabilitation session (NDT-Bobath/PNF) to ensure motor priming.

Control Group (Overground Training): Participants underwent 15 sessions (30 minutes each, 5 days/week for 3 weeks) of traditional overground gait training. To ensure comparability, sessions were matched in duration and intensity (40-85% HRR, Modified Borg < 4). Training focused on manual gait correction, balance exercises, and fall prevention on natural surfaces. Like the experimental group, all control participants received the same standardized 90-minute morning neurorehabilitation (NDT-Bobath/PNF).

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.