NCT03980457 · University of Oklahoma
Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
What this study is about
The goal of this study is to determine the effectiveness of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
View original scientific description
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.
Interventions
DEVICE
Indego Exoskeleton
Powered generated orthosis
OTHER
Standard Rehabilitation
Standard Rehabilitation
Primary outcome measures
The Functional Independence Measure (FIM™)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.
The two minute walk test (2-MWT)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study
- Patients able to stand alone
- 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
- Aphasic patients unable to communicate
- Confused patients
- Patients medically unstable
- Patients unable to stand alone
- Refusal to provide written informed consent
Where
- Oklahoma City, Oklahoma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations