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

NCT07443150 | Completed

• 1 other identifier: 122.6120.32.2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic; Subacute Stroke

Keywords

BWSTT; Body Weight Support Treadmill Training; Neuroendocrinology; Melatonin; Cortisol; Serotonin; β-endorphins; Gait rehabilitation; Neuroprotection; Neuroplasticity; Locomotion; Quality of life

Outcome Measures

Primary Outcomes (6)

• Neuroendocrine Profile: Plasma Cortisol Level

  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

  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

• Functional Walking Capacity (6-Minute Walk Test)

  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.

  Baseline (Day 2) and Post-intervention (Day 21, after 15 training sessions).

• Short-distance Gait Speed (10-Meter Walk Test)

  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

  Baseline (Day 2) and Post-intervention (Day 21, after 15 training sessions).

• Neuroendocrine Profile: Plasma Serotonin Level

  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

  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

• Neuroendocrine Profile: Plasma Melatonin Level

  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

  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

• Neuroendocrine Profile: Plasma β-endorphin Level

  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

  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

Secondary Outcomes (8)

• 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.

Study Arms (2)

Experimental Group (BWSTT)

EXPERIMENTAL

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).

Device: Body Weight Support Treadmill Training (BWSTT)

Control Group (Overground Training)

ACTIVE COMPARATOR

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).

Behavioral: Overground Training

Interventions

Body Weight Support Treadmill Training (BWSTT) DEVICE

BWSTT was performed 15 times (30 min, 5 days/week, 3 weeks) using the Parestand device with 25% dynamic body weight support. Intensity was set at 40-85% HRR (Karvonen formula) and monitored via HR, SpO2 (\>94%), and Borg scale (\<4). Sessions followed AHA/ASA guidelines: 3-min warm-up, incremental main phase, and 3-min cool-down. The physiotherapist provided manual facilitation (pelvic stabilization, knee control) and auditory stimulation (motor priming) to improve gait symmetry. Progression involved increasing speed and duration based on tolerance. Safety criteria for termination included pain, dyspnea, SpO2 \<94%, or Borg scale \>7/10. In the morning (08:00-10:00), all participants received a standardized 90-min neurorehabilitation session (NDT-Bobath/PNF) focusing on muscle tone normalization and postural control. This combined approach ensured motor priming prior to the gait-specific intervention.

Experimental Group (BWSTT)

Overground Training BEHAVIORAL

Overground gait training was performed 15 times (30 min, 5 days/week, 3 weeks). Intensity was matched to the experimental group using the Karvonen formula (40-85% HRR) and Borg scale (\<4). Sessions followed an identical structure (3-min warm-up/cool-down) and progression rules. Patients ambulated independently or with orthopedic aids. The physiotherapist supervised each session, correcting the gait pattern using neurophysiological techniques (hip approximation, manual resistance) to facilitate motor activity and ensure safety against falls. In the morning (08:00-10:00), all participants received the same standardized 90-min neurorehabilitation session (NDT-Bobath/PNF) focusing on muscle tone normalization and postural control to ensure motor priming. This baseline therapy was identical for both groups, with the gait training environment (overground vs. treadmill with BWS) being the primary differentiating factor.

Control Group (Overground Training)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Małopolski Szpital Rehabilitacyjny

Krzeszowice, Małopolska, 32-065, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Beata Stach

  Department of Physiotherapy, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant Professor

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 2, 2026
• Study Start: July 3, 2017
• Primary Completion: April 20, 2019
• Study Completion: May 24, 2024
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)