Clinical trial NCT03980457: Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
Official title: Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Weakness of Extremities as Sequela of Stroke
Keywords: Stroke
leg weakness
Exoskeleton
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label pragmatic study
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Functional Independence Measure (FIM™)
timeFrame: Baseline (Day 1) and at 4-weeks to measure change
measure: The two minute walk test (2-MWT)
timeFrame: Baseline (Day 1) and at 4-weeks to measure change
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline (Day 1) and at 4-weeks to measure change
measure: Discharge disposition
timeFrame: 4-weeks
measure: The Beck Depression Inventory (BDI)
timeFrame: Baseline (Day 1) and at 4-weeks to measure change
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma City VA Health Care System
state: Oklahoma
Study officials:
affiliation: Affiliate; Oklahoma VA Health Care System
name: Meheroz H Rabadi, MD, MRCPI
role: PRINCIPAL_INVESTIGATOR
References: