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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Hybrid combination of physical therapy and powered exoskeleton; Other: Powered Exoskeleton Only; Other: Physical Therapy only

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Davidson, MSE MPH; Phone Number: 9095586516; Email: mdavidson@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University
      • Contact: Michael J Davidson, MSE MPH; Phone Number: 909-558-6516; Email: mdavidson@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A - Hybrid combination; Group A (n=12) will receive 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.	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
Experimental: Group B - Powered Exoskeleton only; Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks.	Other: Powered Exoskeleton Only; 18 visits of powered exoskelton only, three times a week for approximately 6 weeks
Experimental: Group C - Physical Therapy only; Group C (n=12) will receive 18 visits of physical therapy, three times a week for approximately 6 weeks. Upon completion of the data collection portion of the study, group C will receive 9 sessions, three times a week for approximately three weeks of powered exoskeleton therapy. Data will not be collected or reported during this phase, but but may be retained for future approved use.	Other: Physical Therapy only; 18 visits of physical therapy only, three times a week for approximately 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Michael Davidson, MSE MPH, Loma Linda University O&P

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Gait; Physical Therapy; Exoskeleton; Motor-learning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 5190407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No