NCT04824482Recruiting
Gait Recovery in Patients After Acute Ischemic Stroke
GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
Source: ClinicalTrials.gov · Last updated 29 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
More than 80% of ischemic stroke (IS) patients have some walking disability, which restricts their independence in the activities of daily living. Physical therapy (PT) significantly contributes to gait recovery in patients after IS. However, it remains unclear, what type of gait training is more effective and which factors may have impact on gait recovery. Two hundred fifty IS patients will be enrolled to undergo a 2-week intensive inpatient rehabilitation including randomly assigned robot-assisted treadmill gait training (RTGT) or therapist-assisted treadmill gait training (TTGT). A detailed clinical and laboratory assessment of gait quality, as well as the degree of neurological impairment, quality of life, cognition and depression will be performed in all patients during the study. We hypothesize that these variables may also affect gait recovery in patients after IS. In a randomly selected 60 enrolled patients, a multi-modal magnetic resonance imaging (MRI), including functional MRI, will be performed to assess neural correlates and additional predictors of gait recovery.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 24 Mar 2021
- Start date
- 1 Sept 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University Hospital Olomouc
- Diseases
- Stroke
- NCT number
- NCT04824482
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of any stroke, either ischemic or hemorrhagic
- Other diseases modifying or limiting walking ability, currently receiving rehabilitation or participation in another study
- 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
- 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
Other illness
- Significant/symptomatic ischemic heart disease or significant/symptomatic peripheral arterial disease
- Known cognitive impairment
- Presence of other orthopedic or neurological conditions affecting the lower extremities
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.