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Gait Recovery in Patients After Acute Ischemic Stroke (GAITFAST)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Robot-assisted treadmill gait training (RTGT)
Therapist-assisted treadmill gait training (TTGT)
Sponsored by
University Hospital Olomouc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic Stroke, Stroke rehabilitation, Physical Therapy, Gait, Exoskeleton Device, Walking speed, Gait Analysis, Functional Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital OlomoucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted treadmill gait training (RTGT)

Therapist-assisted treadmill gait training (TTGT)

Arm Description

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.

Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.

Outcomes

Primary Outcome Measures

Change in gait speed during overground walking
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

Change in National Institute of Health Stroke Scale (NIHSS)
NIHSS is used to objectively quantify the impairment caused by a stroke.
Change in gait speed (km/h) during patients´ comfort speed
Gait speed will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in gait cadence (steps/min) during patients´ comfort speed
Gait cadence will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in paretic and non-paretic leg step length (cm) during patients´ comfort speed
Change in paretic and non-paretic leg step length will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in duration of stance phase as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed
Change in duration of stance phase will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in double stance phase as percentage of gait cycle (%) during patients´ comfort speed
Change in double stance phase will be assessed by treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in ground reaction force (N) for paretic and non-paretic limb during patients' comfort speed
Change in ground reaction force will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in plantar pressure distribution (N/cm2) for paretic and non-paretic limb during patients´ comfort speed
Change in plantar pressure distribution will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
Change in Functional Ambulatory Category FAC
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.
Change in Fugl-Meyer Assessment
Fugl-Meyer Assessment uses to examine the sensory-motor function and coordination of affected lower extremity.
Change in functional magnetic resonance imaging activation magnitude
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.
Change in functional magnetic resonance imaging activation volume
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.

Full Information

First Posted
March 24, 2021
Last Updated
July 27, 2022
Sponsor
University Hospital Olomouc
Collaborators
Palacky University
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1. Study Identification

Unique Protocol Identification Number
NCT04824482
Brief Title
Gait Recovery in Patients After Acute Ischemic Stroke
Acronym
GAITFAST
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Olomouc
Collaborators
Palacky University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic Stroke, Stroke rehabilitation, Physical Therapy, Gait, Exoskeleton Device, Walking speed, Gait Analysis, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted treadmill gait training (RTGT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapist-assisted treadmill gait training (TTGT)
Arm Type
Active Comparator
Arm Description
Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.
Intervention Type
Other
Intervention Name(s)
Robot-assisted treadmill gait training (RTGT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapist-assisted treadmill gait training (TTGT)
Intervention Description
Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.
Primary Outcome Measure Information:
Title
Change in gait speed during overground walking
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change in National Institute of Health Stroke Scale (NIHSS)
Description
NIHSS is used to objectively quantify the impairment caused by a stroke.
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)
Title
Change in gait speed (km/h) during patients´ comfort speed
Description
Gait speed will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in gait cadence (steps/min) during patients´ comfort speed
Description
Gait cadence will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in paretic and non-paretic leg step length (cm) during patients´ comfort speed
Description
Change in paretic and non-paretic leg step length will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in duration of stance phase as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed
Description
Change in duration of stance phase will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in double stance phase as percentage of gait cycle (%) during patients´ comfort speed
Description
Change in double stance phase will be assessed by treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in ground reaction force (N) for paretic and non-paretic limb during patients' comfort speed
Description
Change in ground reaction force will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in plantar pressure distribution (N/cm2) for paretic and non-paretic limb during patients´ comfort speed
Description
Change in plantar pressure distribution will be assessed by instrumented treadmill gait analysis system (Zebris Medical GmbH, FDM-T system).
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)
Title
Change in Functional Ambulatory Category FAC
Description
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.
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)
Title
Change in Fugl-Meyer Assessment
Description
Fugl-Meyer Assessment uses to examine the sensory-motor function and coordination of affected lower extremity.
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)
Title
Change in functional magnetic resonance imaging activation magnitude
Description
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.
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)
Title
Change in functional magnetic resonance imaging activation volume
Description
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.
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)
Other Pre-specified Outcome Measures:
Title
Change in Montreal Cognitive Assessment (MoCA) Test
Description
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.
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)
Title
Change in Modified Rankin Scale
Description
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.
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)
Title
Change in Barthel index
Description
Barthel index is scale used to measure performance in activities of daily living (ADL). The maximum score is 100 points.
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)
Title
Change in Timed Up and Go test
Description
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.
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)
Title
Change in Lower limb muscle strength assessment
Description
Medical Research Council Scale for Muscle Strength will be used for 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)
Title
Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during the 10 Meter Walk
Description
Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) will be assessed by surface electromyography (Delsys Trigno EMG/IMU sensors).
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)
Title
Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) during treadmill gait
Description
Change in lower limb muscles activity (medial gastrocnemius, tibialis anterior, quadriceps, hamstrings) will be assessed by surface electromyography (Delsys Trigno EMG/IMU sensors).
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)
Title
Change in Beck Depression Inventory Scale
Description
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.
Time Frame
Enrollment, after three weeks (at the end of inpatient RHB), and in follow-up (after three and six months after stroke onset)
Title
Change in EQ-5D-3L Questionnaire
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbora Kolarova, PhD
Phone
+420 588 442 301
Email
barbora.kolarova@fnol.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Sanak, MD, PhD
Phone
+420588442836
Email
daniel.sanak@fnol.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Hlustik, MD, PhD
Organizational Affiliation
Palacky University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Kolar, MD, PhD
Phone
+420588445197
Email
petr.kolar@fnol.cz
First Name & Middle Initial & Last Name & Degree
Daniel Sanak, MD, PhD
Phone
+420588442836
Email
daniel.sanak@fnol.cz

12. IPD Sharing Statement

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Gait Recovery in Patients After Acute Ischemic Stroke

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