Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke

University of Oklahoma (OU)

Status: Enrolling

Conditions: Stroke; Weakness of Extremities as Sequela of Stroke

Treatments: Device: Indego Exoskeleton; Other: Standard Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03980457

10742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Exo-group

Experimental group

Description:

Standard rehabilitation plus use of Exoskeleton

Treatment:

Device: Indego Exoskeleton

Other: Standard Rehabilitation

Control-Group

Placebo Comparator group

Description:

Standard rehabilitation

Treatment:

Other: Standard Rehabilitation