Improving walking ability in patients after ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on enhancing gait recovery in patients who have experienced an ischemic stroke. It involves a two-week intensive inpatient rehabilitation program where participants are randomly assigned to either robot-assisted treadmill gait training (RTGT) or therapist-assisted treadmill gait training (TTGT). The study will assess various factors, including gait quality, neurological impairment, quality of life, cognition, and depression, to determine their impact on recovery. Additionally, a subset of patients will undergo advanced MRI imaging to explore brain structures related to gait recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ischemic stroke detected on magnetic resonance imaging (MRI) with NIHSS score 1-12 points at the time of enrolment
* Lower limb movement impairment with a score of at least 1 point on the NIH Stroke Scale (NIHSS) at the time of enrolment
* Dependency in walking according to Functional Ambulatory Category (FAC) with score interval \<1,3\> (supervision or assistance, or both, must be given in performing walking)

Exclusion Criteria:

* Previous history of any stroke, either ischemic or hemorrhagic
* Other diseases modifying or limiting walking ability, currently receiving rehabilitation or participation in another study
* Significant/symptomatic ischemic heart disease or significant/symptomatic peripheral arterial disease
* Obesity (BMI ≥ 40), or weight higher than 110 kg (weight limit for the robot-assisted gait training)
* Sensory aphasia with the inability to understand having been verified by a certified speech therapist.
* Moderate or severe depression present at the time of enrolment assessed using the Beck scale, with a score above 10.
* Known cognitive impairment
* Previous disability or dependence in the daily activities assessed using the modified Rankin Scale with a score of 3 and more points
* Currently receiving dialysis
* Diagnosed and/or receiving treatment for cancer
* Presence of other orthopedic or neurological conditions affecting the lower extremities
* For fMRI: Pregnancy; electronic implants, including cochlear implant, pacemaker, neurostimulator; incompatible metallic implants, including aneurysm clip; metallic intraocular foreign body; large tattoos; unremovable piercing; body weight over 150 kg; known claustrophobia

Where it's running

• University Hospital Olomouc
  Olomouc, Czechia Recruiting

Study contacts

• Study coordinator: Barbora Kolarova, PhD
• Email: barbora.kolarova@fnol.cz
• Phone: +420 588 442 301

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.