Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted
 gait training on rehabilitation functional outcomes in patients with stroke undergoing
 therapy in an in-patient rehabilitation facility.
Abstract

 Objective: The goal of this study is to determine the efficacy of electromechanical
 exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with
 stroke undergoing therapy in an in-patient rehabilitation facility.

 Background:

 Method: The investigators will study 50 patients with stroke consecutively admitted to a
 designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients
 will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or
 over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either
 the experimental (exoskeleton) or the control (over-ground) groups by computer-generated
 randomization. This is an open-label pragmatic trial, where neither the patients nor the
 clinicians could be masked to the intervention. Institution review board (IRB) approval will
 be obtained for the protocol. The demographic data to be collected includes: age, gender,
 race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke
 severity (on the National Institute of Health Stroke Severity [NIHSS] scale. Admission and
 discharge total Functional Independence Measure (FIM), spasticity and depression scores,
 ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The
 intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM,
 depression and spasticity scores. The secondary outcome measure was discharge disposition.
 Continuous variables were analyzed using Students t-test, ordinal variables were analyzed
 using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.
Inclusion Criteria:

 1. All patients with acute hemorrhagic or ischemic stroke documented clinically and by
 neuroimaging.

 2. Medically stable from a cardio-respiratory stand point so that they can participate in
 daily therapies.

 3. Depressed patients will be included in the study

 4. Patients able to stand alone

 5. Patients able to provide a written informed consent, from cognitively intact patients
 (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21).

 Exclusion Criteria:

 1. Aphasic patients unable to communicate

 2. Confused patients

 3. Patients medically unstable

 4. Patients unable to stand alone

 5. Refusal to provide written informed consent