Gait Recovery in Patients After Acute Ischemic Stroke

NCT ID: NCT04824482

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robot-assisted treadmill gait training (RTGT)

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.

Group Type: EXPERIMENTAL

Robot-assisted treadmill gait training (RTGT)

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Therapist-assisted treadmill gait training (TTGT)

Intervention Type: OTHER

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

Interventions

Robot-assisted treadmill gait training (RTGT)

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

Therapist-assisted treadmill gait training (TTGT)

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Palacky University

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: lead

Responsible Party

Barbora Kolarova

Head of Kinesiology Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Hlustik, MD, PhD

Role: STUDY_CHAIR

Palacky University

Locations

University Hospital Olomouc

Olomouc, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Barbora Kolarova, PhD

Role: CONTACT

barbora.kolarova@fnol.cz

+420 588 442 301

Daniel Sanak, MD, PhD

Role: CONTACT

daniel.sanak@fnol.cz

+420588442836

Facility Contacts

Petr Kolar, MD, PhD

Role: primary

petr.kolar@fnol.cz

+420588445197

Daniel Sanak, MD, PhD

Role: backup

daniel.sanak@fnol.cz

+420588442836

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Other Identifiers

NU21-04-00375

Identifier Type: -

Identifier Source: org_study_id