Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
NCT ID: NCT03980457
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-09-01
2028-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exo-group
Standard rehabilitation plus use of Exoskeleton
Indego Exoskeleton
Powered generated orthosis
Standard Rehabilitation
Standard Rehabilitation
Control-Group
Standard rehabilitation
Standard Rehabilitation
Standard Rehabilitation
Interventions
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Indego Exoskeleton
Powered generated orthosis
Standard Rehabilitation
Standard Rehabilitation
Eligibility Criteria
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Inclusion Criteria
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
2. Confused patients
3. Patients medically unstable
4. Patients unable to stand alone
5. Refusal to provide written informed consent
18 Years
90 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Meheroz H Rabadi, MD, MRCPI
Role: PRINCIPAL_INVESTIGATOR
Affiliate; Oklahoma VA Health Care System
Locations
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Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Meheroz Rabadi, MD, MRCPI
Role: primary
Other Identifiers
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10742
Identifier Type: -
Identifier Source: org_study_id