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NCT Number: NCT04824482

Gait Recovery in Patients After Acute Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted treadmill gait training (RTGT)

Other

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.

Therapist-assisted treadmill gait training (TTGT)

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbora Kolarova, PhD

CONTACT

[email protected]

+420 588 442 301

Daniel Sanak, MD, PhD

CONTACT

[email protected]

+420588442836

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.

Acronym: GAITFAST

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 1, 2021
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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