A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton

Stroke Clinical Trial

Official title:

A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton in the Treatment of Individuals With Sub-acute and Chronic Stroke.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648878
• Other study ID #: 5190407
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Loma Linda University
• Contact: Michael Davidson, MSE MPH
• Phone: 9095586516
• Email: mdavidson[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this investigator-initiated study is to establish if powered exoskeleton therapy as a part of a rehabilitation program can be used as a standard of care in stroke rehabilitation.

Description:

This prospective randomized control trial with three treatment arms will begin by:

• Determining if the subject is a candidate for exoskeleton treatment.

• Randomly assigning subjects to three groups (physical therapy only, exoskeleton only, or a hybrid of physical therapy and exoskeleton).

• Body measurements to individualize the fit of the exoskeleton to each subject at each session.

• Activities-based balance confidence (ABC) questionnaire will be administered before and after the study begins.

• Timed up and go test (TUGT).

• Ten-meter walk test (10MWT).

• Six-minute walk test (6MWT)

• Berg Balance Test (BBT).

• Five times sit to stand (5XSTS).

• Heart rate through a portable heartrate monitor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and Females 18 years of age or older post-stroke

• 3 Ashworth score are involved in a standing program less than 220 lbs 5'0" through 6'4" have the ability to follow one-step commands near normal range-of-motion for the knees, hips, and ankles

Exclusion Criteria:

• Exclusion criteria will include those who have already experienced powered exoskeleton therapy.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Hybrid combination of physical therapy and powered exoskeleton
18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks
• Powered Exoskeleton Only
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
• Physical Therapy only
18 visits of physical therapy only, three times a week for approximately 6 weeks

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go test	Subject sits in a standard armchair and stands, and at a self-selected walking speed, walks 3 meters, turns, and walks back to the chair, and sits down. They will be timed. Takes three minutes to administer.	Pre and post tests up to six weeks apart
Primary	Ten meter walk test	Subjects will be timed as they walk a known distance of 10 meters to determine his self-selected walking velocity (distance/time). They will be timed. Takes five minutes to administer.	Pre and post tests up to six weeks apart
Primary	6 minute walk test	This test measures distance walked in six minutes to assess a patient's physical endurance. They walk at a self-selected speed and will be timed. This test takes approximately 10 minutes to administer	Pre and post tests up to six weeks apart
Primary	Berg Balance Test	The Berg balance test is a reliable measure for predicting risk for fall. This 14-item test measures static and dynamic balance measures and takes 15-20 minutes to administer	Pre and post tests up to six weeks apart
Primary	The Activities-specific Balance Confidence (ABC) Scale	This has been shown to be an effective tool for assessing the psychological impact of balance impairment and falls and measuring an individual's balance confidence. Using a Likert scale, this self-administered test evaluates a person's confidence in balance over various activities. This 16-question test takes 5 to 10 minutes to complete.	Pre and post tests up to six weeks apart