StrokeNCT04648878
A Comparison of Conventional Physical Therapy, Powered Exoskeleton, and Hybrid Physical Therapy With Exoskeleton
A study testing Hybrid combination of physical therapy and powered exoskeleton, Powered Exoskeleton Only and Physical Therapy only in people with Stroke, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Hybrid combination of physical therapy and powered exoskeleton, Powered Exoskeleton Only and Physical Therapy only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2021to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion criteria will include those who have already experienced powered exoskeleton therapy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Hybrid combination of physical therapy and powered exoskeleton, Powered Exoskeleton Only, Physical Therapy only
- Keywords
- Stroke, Exoskeleton, Gait, Physical Therapy, Motor-learning
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid combination of physical therapy and powered exoskeletonOther
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
Powered Exoskeleton OnlyOther
18 visits of powered exoskelton only, three times a week for approximately 6 weeks
Physical Therapy onlyOther
18 visits of physical therapy only, three times a week for approximately 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Physical Therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Pre and post tests up to six weeks apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start14 Feb 2021
- Primary completion20 Nov 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Davidson, MSE MPH, Principal investigator, Loma Linda University O&P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648878
- Sponsor's protocol ID
- 5190407
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2020
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04648878
- Acronym / sponsor ID
- 5190407
- Conditions
- Stroke
- Keywords
- Stroke, Exoskeleton, Gait, Physical Therapy, Motor-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Hybrid combination | Experimental | Other: Hybrid combination of physical therapy and powered exoskeletonGroup 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 B - Powered Exoskeleton only | Experimental | Other: Powered Exoskeleton OnlyGroup B (n=12) will receive 18 visits of powered exoskeleton only, three times a week for approximately 6 weeks. |
| Group C - Physical Therapy only | Experimental | Other: Physical Therapy onlyGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and Females 18 years of age or older post-stroke
Key exclusion criteria (1 listed)
- Exclusion criteria will include those who have already experienced powered exoskeleton therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid combination of physical therapy and powered exoskeleton18 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 | Group A - Hybrid combination |
| Powered Exoskeleton Only18 visits of powered exoskelton only, three times a week for approximately 6 weeks | Other | Group B - Powered Exoskeleton only |
| Physical Therapy only18 visits of physical therapy only, three times a week for approximately 6 weeks | Other | Group C - Physical Therapy only |
Primary outcome
Timed up and go test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Davidson, MSE MPH principal investigator
Loma Linda University O&P
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid combination of physical therapy and powered exoskeleton, Powered Exoskeleton Only and Physical Therapy only in people with Stroke, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go test (time frame: Pre and post tests up to six weeks apart). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.