Gait Recovery in Patients After Acute Ischemic Stroke (GAITFAST)

• ClinicalTrials.gov Identifier: NCT04824482
• Recruitment Status: Recruiting
• First Posted: April 1, 2021
• Last Update Posted: April 27, 2021
• Sponsor: University Hospital Olomouc
• Collaborator: Palacky University
• Information provided by (Responsible Party): Barbora Kolarova, University Hospital Olomouc

Study Description

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-mediated gait training (RGT) or therapist-assisted gait training (TGT). 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.

Condition or disease	Intervention/treatment	Phase
Ischemic Stroke	Other: Robot-assisted gait training (RGT); Other: Therapist-assisted gait training (TGT)	Not Applicable

Detailed Description:

Two hundred fifty 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-mediated gait training (RGT) or therapist-assisted gait training (TGT) after acute phase (5-10 days after stroke onset). All enrolled patients will undergo a 2-week intensive inpatient rehabilitation including randomly assigned TGT or RGT 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: December 31, 2025
• Estimated Study Completion Date: December 31, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Robot-assisted gait training (RGT); Locomotor training guided by the robotic device (Lokomat Hocoma) according to a pre-programmed gait pattern with the help of robot-driven exoskeleton orthoses. The process of gait training is automated and controlled by a computer under supervision of a physiotherapist.	Other: Robot-assisted gait training (RGT); Locomotor training guided by the robotic device (Lokomat Hocoma) according to a pre-programmed gait pattern with the help of robot-driven exoskeleton orthoses. The process of gait training is automated and controlled by a computer under supervision of a physiotherapist.
Active Comparator: Therapist-assisted gait training (TGT); Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.	Other: Therapist-assisted gait training (TGT); Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.

Outcome Measures

Primary Outcome Measures :

1. Change in gait speed during overground walking [ Time Frame: 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) ]
   Gait speed will be measured using the 10 Meters Walking Test (performance measure used to assess walking speed in meters per second over a short distance). The subject will be asked to walk for a distance of 10 meters at his/her comfortable speed. The time will be measured for the distance of the middle six meters, which will allow walk acceleration and deceleration. Each patient will perform two trials with a calculation of mean time value. If physical assistance of another person (to prevent a fall or collapsing) is needed for a patient to complete the test, the level of assistance provided will be documented. Usage of any assistive device and/or bracing (that patients are currently using for walking and are needed to complete the test) will be also documented.

Secondary Outcome Measures :

1. Change in National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 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) ]
   NIHSS is used to objectively quantify the impairment caused by a stroke.
2. Change in gait speed (km/h) during patients´ comfort speed [ Time Frame: 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) ]
   Gait speed will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
3. Change in gait cadence (steps/min) during patients´ comfort speed [ Time Frame: 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) ]
   Gait cadence will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
4. Change in paretic and non-paretic leg step length (cm) during patients´ comfort speed [ Time Frame: 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) ]
   Change in paretic and non-paretic leg step length will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
5. Change in duration of stance phase as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed [ Time Frame: 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) ]
   Change in duration of stance phase will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
6. Change in double stance phase as percentage of gait cycle (%) during patients´ comfort speed [ Time Frame: 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) ]
   Change in double stance phase will be assessed by treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
7. Change in ground reaction force (N) for paretic and non-paretic limb during patients' comfort speed [ Time Frame: 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) ]
   Change in ground reaction force will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
8. Change in plantar pressure distribution (N/cm2) for paretic and non-paretic limb during patients´ comfort speed [ Time Frame: 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) ]
   Change in plantar pressure distribution will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
9. Change in Functional Ambulatory Category FAC [ Time Frame: 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) ]
   Functional walking test that assess gait ability with 6 levels ranging from 0 to 5 on the basis of the amount of physical support required.
10. Change in Fugl-Meyer Assessment [ Time Frame: 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) ]
    Fugl-Meyer Assessment uses to examine the sensory-motor function and coordination of affected lower extremity.
11. Change in functional magnetic resonance imaging activation magnitude [ Time Frame: 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) ]
    Functional MRI activation magnitude, calculated as difference in BOLD signal between task and rest, will be assessed within pre-defined gait-related brain regions of interest (ROIs), i.e., sensorimotor cortex, premotor cortex, supplementary motor area, brainstem and cerebellum. Change in these ROI parameters over time will be statistically tested within group and the regional post-training minus pre-training difference in each group will be submitted to between-group analysis.
12. Change in functional magnetic resonance imaging activation volume [ Time Frame: 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) ]
    Functional MRI activation volume, summed over significantly activated voxels, will be assessed within pre-defined gait-related brain regions of interest (ROIs), i.e., sensorimotor cortex, premotor cortex, supplementary motor area, brainstem and cerebellum. Change in these ROI parameters over time will be statistically tested within group and the regional post-training minus pre-training difference in each group will be submitted to between-group analysis.

Other Outcome Measures:

1. Change in Montreal Cognitive Assessment (MoCA) Test [ Time Frame: 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) ]
   MoCA is cognitive screening test designed to detection cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation.
2. Change in Modified Rankin Scale [ Time Frame: 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) ]
   Scale used for measuring the degree of disability or dependence in the daily activities in patients after stroke. Most widely used clinical outcome measure after stroke. Scale has six points and higher score means worse outcome; minimum is 0 points indicating no symptoms at all and maximum is 6 points indicating death.
3. Change in Barthel index [ Time Frame: 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) ]
   Barthel index is scale used to measure performance in activities of daily living (ADL). The maximum score is 100 points.
4. Change in Timed Up and Go test [ Time Frame: 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) ]
   Clinical test used to assess a person's mobility which requires both static and dynamic balance. The objective of this test is to determine fall risk and measure the progress of balance, sit to stand and walking.
5. Change in Lower limb muscle strength assessment [ Time Frame: 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) ]
   Medical Research Council Scale for Muscle Strength will be used for assessment
6. Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during the 10 Meter Walk [ Time Frame: 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) ]
   Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) will be assessed by surface electromyography (Delsys Trigno EMG/IMU sensors).
7. Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during treadmill gait [ Time Frame: 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) ]
   Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) will be assessed by surface electromyography (Delsys Trigno EMG/IMU sensors).
8. Change in Beck Depression Inventory Scale [ Time Frame: Enrollment, after three weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset) ]
   A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item (question) had a set of at least four possible responses, ranging in intensity. 0-9: indicates minimal depression and 30-63 points indicates severe depression. Higher total scores indicate more severe depressive symptoms.
9. Change in EQ-5D-3L Questionnaire [ Time Frame: 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) ]
   Standard layout for recording an adult person's current self-reported health state. Consists of a standard format for respondents to record their health state according to the EQ-5D-3L descriptive system and the EQ VAS.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Barbora Kolarova, PhD; +420 588 442 301; barbora.kolarova@fnol.cz

Contact: Daniel Sanak, MD, PhD; +420588442836; daniel.sanak@fnol.cz

Locations

Czechia

University Hospital Olomouc; Recruiting

Olomouc, Czechia, 77520

Contact: Petr Kolar, MD, PhD +420588445197 petr.kolar@fnol.cz

Contact: Daniel Sanak, MD, PhD +420588442836 daniel.sanak@fnol.cz

Sponsors and Collaborators

University Hospital Olomouc

Palacky University

Investigators

• Study Chair: Petr Hlustik, MD, PhD; Palacky University

More Information

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• Responsible Party: Barbora Kolarova, Head of Kinesiology Laboratory, University Hospital Olomouc
• ClinicalTrials.gov Identifier: NCT04824482
• Other Study ID Numbers: NU21-04-00375
• First Posted: April 1, 2021
• Last Update Posted: April 27, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Barbora Kolarova, University Hospital Olomouc:

Ischemic Stroke; Stroke rehabilitation; Physical Therapy; Gait; Exoskeleton Device; Walking speed; Gait Analysis; Functional Magnetic Resonance Imaging

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis