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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03980457
• Other study ID #: 10742
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2028

Study information

• Verified date: November 2023
• Source: University of Oklahoma
• Contact: Meheroz H Rabadi, MD, MRCPI
• Phone: 405-456-5298
• Email: rabadimh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Weakness of Extremities as Sequela of Stroke

Intervention

Device:
• Indego Exoskeleton
Powered generated orthosis

Other:
• Standard Rehabilitation
Standard Rehabilitation

Locations

Country	Name	City	State
United States	Oklahoma City VA Health Care System	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Functional Independence Measure (FIM™)	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
Primary	The two minute walk test (2-MWT)	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	Modified Ashworth Scale (MAS)	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
Secondary	Discharge disposition	Looks at effectiveness of rehabilitation as to how many patients are discharged home. Higher percentage 65% and above the better outcome.	4-weeks
Secondary	The Beck Depression Inventory (BDI)	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