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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Powered Exoskeleton Only; Other: Hybrid combination of physical therapy and powered exoskeleton; Other: Physical Therapy only

• Registration Number: NCT04648878
• Lead Sponsor: Loma Linda University

Brief 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.

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 Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2021-02-14
• Primary Completion: 2024-11-20
• Study Completion: 2024-12-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B - Powered Exoskeleton only	Powered Exoskeleton Only	Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks.
Group A - Hybrid combination	Hybrid combination of physical therapy and powered exoskeleton	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.
Group C - Physical Therapy only	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.

Primary Outcome Measures

Name	Time	Method
Timed up and go test	Pre and post tests up to six weeks apart	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.
Ten meter walk test	Pre and post tests up to six weeks apart	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.
6 minute walk test	Pre and post tests up to six weeks apart	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
Berg Balance Test	Pre and post tests up to six weeks apart	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
The Activities-specific Balance Confidence (ABC) Scale	Pre and post tests up to six weeks apart	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.

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States