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

NCT07443150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Beata Stach · Department of Physiotherapy, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2019-04-20
Completion
2024-05-24

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443150 on ClinicalTrials.gov