Clinical trial NCT04824482: Gait Recovery in Patients After Acute Ischemic Stroke
Official title: GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke
Stroke rehabilitation
Physical Therapy
Gait
Exoskeleton Device
Walking speed
Gait Analysis
Functional Magnetic Resonance Imaging
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2021-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will be randomly assigned to two parallel intervention groups for the duration of study. Thirty patients from each intervention group will be randomized to multimodal MRI of brain.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: One hundred twenty consecutive first ever ischemic stroke patients classified as dependent walkers (Functional Ambulatory Category interval \<1,3\>) will be enrolled in the randomized blinded single center prospective clinical trial GAITFAST with a randomization either for robot-assisted treadmill gait training (RGT) or therapist-assisted treadmill gait training (TTGT) after acute phase (5-10 days after stroke onset). All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including randomly assigned TTGT or RTGT followed with clinical visits (at the beginning of inpatient rehabilitation, at discharge, and three and six months after enrollment in the study). Each clinical visit will include detailed clinical functional assessments, assessment of spatiotemporal and kinetic gait parameters, assessment of neurological impairment, assessment of quality of life, cognition and depression. In 60 randomly selected enrolled IS patients, a repeated multi-modal magnetic resonance imaging (MRI) including functional MRI (fMRI) will be performed during the study follow-up to identify brain structures with possible impact on gait recovery.

Eligibility criteria: 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

Primary outcomes:
measure: Change in gait speed during overground walking
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
Secondary outcomes:
measure: Change in National Institute of Health Stroke Scale (NIHSS)
timeFrame: Enrollment, baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in gait speed (km/h) during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in gait cadence (steps/min) during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in paretic and non-paretic leg step length (cm) during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in duration of stance phase as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in double stance phase as percentage of gait cycle (%) during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in ground reaction force (N) for paretic and non-paretic limb during patients' comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in plantar pressure distribution (N/cm2) for paretic and non-paretic limb during patients´ comfort speed
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Functional Ambulatory Category FAC
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Fugl-Meyer Assessment
timeFrame: baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in functional magnetic resonance imaging activation magnitude
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in functional magnetic resonance imaging activation volume
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
Other outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA) Test
timeFrame: Enrollment, baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Modified Rankin Scale
timeFrame: Enrollment, baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Barthel index
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Timed Up and Go test
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Lower limb muscle strength assessment
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during the 10 Meter Walk
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during treadmill gait
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in Beck Depression Inventory Scale
timeFrame: Enrollment, after three weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
measure: Change in EQ-5D-3L Questionnaire
timeFrame: Baseline (before beginning of inpatient RHB), after two weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: Palacky University
name: Petr Hlustik, MD, PhD
role: STUDY_CHAIR
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