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

Status: Recruiting
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Contact Information
Primary
Barbora Kolarova, PhD
barbora.kolarova@fnol.cz
+420 588 442 301
Backup
Daniel Sanak, MD, PhD
daniel.sanak@fnol.cz
+420588442836
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Active_comparator: Therapist-assisted treadmill gait training (TTGT)
Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.
Related Therapeutic Areas
Sponsors
Collaborators: Palacky University
Leads: University Hospital Olomouc

This content was sourced from clinicaltrials.gov