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

Loma Linda University (LLU)

Status: Completed

Conditions: Stroke

Treatments: Other: Physical Therapy only; Other: Hybrid combination of physical therapy and powered exoskeleton; Other: Powered Exoskeleton Only

Study type: Interventional

Funder types: Other

Identifiers

NCT04648878

5190407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 3 patient groups

Group A - Hybrid combination

Experimental group

Description:

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.

Treatment:

Other: Hybrid combination of physical therapy and powered exoskeleton

Group B - Powered Exoskeleton only

Experimental group

Description:

Group B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks.

Treatment:

Other: Powered Exoskeleton Only

Group C - Physical Therapy only

Experimental group

Description:

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.

Treatment:

Other: Physical Therapy only