Gait Recovery in Patients After Acute Ischemic Stroke

ConditionIschemic Stroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorUniversity Hospital Olomouc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Robot-assisted treadmill gait training (RTGT)
Other intervention
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 intervention
Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Robot-assisted treadmill gait training (RTGT)Experimental treatment 1 intervention

Group B: Therapist-assisted treadmill gait training (TTGT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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 outcomes

Change in National Institute of Health Stroke Scale (NIHSS)

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)

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).

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 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).

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 (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).

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 outcomes

Change in Montreal Cognitive Assessment (MoCA) Test

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)

Change in Modified Rankin Scale

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)

Change in Barthel index

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)

Change in Timed Up and Go test

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Olomouc

Lead sponsor

Palacky University

Collaborator

Source ClinicalTrials.gov

Apply now