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

November 29, 2023 updated by: University of Oklahoma
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Oklahoma City VA Health Care System
        • Contact:
        • Principal Investigator:
          • Meheroz Rabadi, MD, MRCPI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exo-group
Standard rehabilitation plus use of Exoskeleton
Device: Indego Exoskeleton
Powered generated orthosis
Other: Standard Rehabilitation
Standard Rehabilitation
Placebo Comparator: Control-Group
Standard rehabilitation
Other: Standard Rehabilitation
Standard Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline (Day 1) and at 4-weeks to measure change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale (MAS)
Time Frame: Baseline (Day 1) and at 4-weeks to measure change
Clinical measure of degree of spasticity. Score varies from 0=normal tome to 4=part rigid in flexion and extension. Lower the score the better the outcome.
Baseline (Day 1) and at 4-weeks to measure change
Discharge disposition
Time Frame: 4-weeks
Looks at effectiveness of rehabilitation as to how many patients are discharged home. Higher percentage 65% and above the better outcome.
4-weeks
The Beck Depression Inventory (BDI)
Time Frame: Baseline (Day 1) and at 4-weeks to measure change
It is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. It ranges in value from 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows: 0-9 indicates person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Baseline (Day 1) and at 4-weeks to measure change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Meheroz H Rabadi, MD, MRCPI, Affiliate; Oklahoma VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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