NCT07443150

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Stroke, Ischemic
• Subacute Stroke

Interventions

Type	Name	Description
DEVICE	Body Weight Support Treadmill Training (BWSTT)	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.
BEHAVIORAL	Overground Training	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.

Timeline

• Start date: 2017-07-03
• Primary completion: 2019-04-20
• Completion: 2024-05-24
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Poland