Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indego Exoskeleton, Standard Rehabilitation.
- Who it may be relevant to
- Registry conditions: Stroke, Weakness of Extremities as Sequela of Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
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]
- The two minute walk test (2-MWT) [Time frame: Baseline (Day 1) and at 4-weeks to measure change]
Secondary outcome measures (3)
- Modified Ashworth Scale (MAS) [Time frame: Baseline (Day 1) and at 4-weeks to measure change]
- Discharge disposition [Time frame: 4-weeks]
- The Beck Depression Inventory (BDI) [Time frame: Baseline (Day 1) and at 4-weeks to measure change]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oklahoma City VA Health Care System — Oklahoma City
Identifiers
NCT: NCT03980457 · 10742