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

Sponsor
Loma Linda University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04648878
Collaborator
(none)
36
Enrollment
1
Location
3
Arms
22.5
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Hybrid combination of physical therapy and powered exoskeleton
  • Other: Powered Exoskeleton Only
  • Other: Physical Therapy only
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Care Provider)
Masking Description:
participants will be instructed to not reveal which treatment arm they have been assigned to
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Feb 14, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Loma Linda UniversityLoma LindaCaliforniaUnited States92354

Sponsors and Collaborators

  • Loma Linda University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Davidson, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier:
NCT04648878
Other Study ID Numbers:
  • 5190407
First Posted:
Dec 2, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Davidson, Assistant Professor, Loma Linda University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022