Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:51 AM
Study NCT ID:
NCT07443150
Status:
COMPLETED
Last Update Posted:
2026-03-02
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of BWSTT on Neuroendocrine Profile and Functional Recovery in Stroke Patients
Sponsor:
Jagiellonian University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: