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

NCT04648878 | Completed

• 1 other identifier: 5190407
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Exoskeleton; Gait; Physical Therapy; Motor-learning

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Group A - Hybrid combination

EXPERIMENTAL

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

Group B - Powered Exoskeleton only

EXPERIMENTAL

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

Other: Powered Exoskeleton Only

Group C - Physical Therapy only

EXPERIMENTAL

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

Interventions

Hybrid combination of physical therapy and powered exoskeleton OTHER

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 A - Hybrid combination

Powered Exoskeleton Only OTHER

18 visits of powered exoskelton only, three times a week for approximately 6 weeks

Group B - Powered Exoskeleton only

Physical Therapy only OTHER

18 visits of physical therapy only, three times a week for approximately 6 weeks

Group C - Physical Therapy only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael Davidson, MSE MPH

  Loma Linda University O&P

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: participants will be instructed to not reveal which treatment arm they have been assigned to
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: February 14, 2021
• Primary Completion: November 20, 2024
• Study Completion: December 18, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

US (1)