CompletedNot Applicable

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

Poland40 participantsStarted 2017-07-03

Plain-language 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.

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pro…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuroendocrine Profile: Plasma Cortisol Level

Timeframe: 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)

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

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

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

Neuroendocrine Profile: Plasma Serotonin Level

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT07443150

SponsorJagiellonian University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-20

View on ClinicalTrials.gov More Stroke, Ischemic trials

Plain-language summary

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neuroendocrine Profile: Plasma Cortisol Level

Timeframe: 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)

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

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

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

Neuroendocrine Profile: Plasma Serotonin Level

Timeframe: 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

Timeframe: 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

Timeframe: 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