Gait Recovery in Patients After Acute Ischemic Stroke

NCT04824482 | Recruiting

• 1 other identifier: NU21-04-00375
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (12)

• Change in National Institute of Health Stroke Scale (NIHSS)

  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)

• Change in gait speed (km/h) during patients´ comfort speed

  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 gait cadence (steps/min) during patients´ comfort speed

  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 (cm) during patients´ comfort speed

  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 as percentage of gait cycle (%) for paretic and non-paretic limb during patients´ comfort speed

  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 (9)

• Change in Montreal Cognitive Assessment (MoCA) Test

  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)

• Change in Modified Rankin Scale

  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)

• Change in Barthel index

  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)

Study Arms (2)

Robot-assisted treadmill gait training (RTGT)

EXPERIMENTAL

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 treadmill gait training (RTGT)

Therapist-assisted treadmill gait training (TTGT)

ACTIVE COMPARATOR

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

Other: Therapist-assisted treadmill gait training (TTGT)

Interventions

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.

Robot-assisted treadmill gait training (RTGT)

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.

Therapist-assisted treadmill gait training (TTGT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Study Sites (1)

University Hospital Olomouc

Olomouc, 77520, Czechia

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Petr Hlustik, MD, PhD

  Palacky University

  STUDY CHAIR

Central Study Contacts

Barbora Kolarova, PhD

CONTACT

+420 588 442 301; barbora.kolarova@fnol.cz

Daniel Sanak, MD, PhD

CONTACT

+420588442836; daniel.sanak@fnol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Kinesiology Laboratory

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: September 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

CZ (1)