StrokeNCT03980457
Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
A study testing Indego Exoskeleton and Standard Rehabilitation in people with Stroke and Weakness of Extremities as Sequela of Stroke, run by University of Oklahoma at 1 site in United States.
Trial summary
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Weakness of Extremities as Sequela of Stroke
- What is being tested?
- Indego Exoskeleton and Standard Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study
- Patients able to stand alone
- Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21).
Who cannot join
- Aphasic patients unable to communicate
- Confused patients
- Patients medically unstable
- Patients unable to stand alone
- Refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oklahoma City VA Health Care System
Oklahoma City, Oklahoma, 73104
Meheroz Rabadi, MD, MRCPI, 405-456-5298, meheroz.rabadi@va.gov
Meheroz Rabadi, MD, MRCPI
About this study
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Read the detailed description
Abstract
Objective: The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Background:
Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity [NIHSS] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.
- Being tested
- Indego Exoskeleton, Standard Rehabilitation
- Keywords
- Stroke, leg weakness, Exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indego ExoskeletonDevice
Powered generated orthosis
Standard RehabilitationOther
Standard Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Exo-group | Experimental | Standard rehabilitation plus use of Exoskeleton Receives: Device: Indego Exoskeleton; Other: Standard Rehabilitation |
| Control-Group | Placebo comparator | Standard rehabilitation Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Independence Measure (FIM™)
It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.
Measured: Baseline (Day 1) and at 4-weeks to measure change
The two minute walk test (2-MWT)
It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.
Measured: Baseline (Day 1) and at 4-weeks to measure change
Secondary outcomes (3)
Modified Ashworth Scale (MAS)
Clinical measure of degree of spasticity. Score varies from 0=normal tome to 4=part rigid in flexion and extension. Lower the score the better the outcome.
Measured: Baseline (Day 1) and at 4-weeks to measure change
Discharge disposition
Looks at effectiveness of rehabilitation as to how many patients are discharged home. Higher percentage 65% and above the better outcome.
Measured: 4-weeks
The Beck Depression Inventory (BDI)
It is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. It ranges in value from 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows: 0-9 indicates person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Measured: Baseline (Day 1) and at 4-weeks to measure change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Sep 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
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 University of OklahomaThe 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
- Parallel groups
- Model description
- Open label pragmatic study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meheroz H Rabadi, MD, MRCPI, Principal investigator, Affiliate; Oklahoma VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980457
- Sponsor's protocol ID
- 10742
- Status last verified
- Mar 2026
- First submitted
- 2 May 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03980457
- Acronym / sponsor ID
- 10742
- Keywords
- Stroke, leg weakness, Exoskeleton
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 10 Jun 2019 (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 goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Detailed description
Abstract
Objective: The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Background:
Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity [NIHSS] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label pragmatic study
| Arm | Type | Receives |
|---|---|---|
| Exo-group | Experimental | Device: Indego Exoskeleton, Other: Standard RehabilitationStandard rehabilitation plus use of Exoskeleton |
| Control-Group | Placebo comparator | Other: Standard RehabilitationStandard rehabilitation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
- Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
- Depressed patients will be included in the study
- Patients able to stand alone
- Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination [MMSE] greater than or equal to 21).
Key exclusion criteria (5 listed)
- Aphasic patients unable to communicate
- Confused patients
- Patients medically unstable
- Patients unable to stand alone
- Refusal to provide written informed consent
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 |
|---|---|---|
| Indego ExoskeletonPowered generated orthosis | Device | Exo-group |
| Standard RehabilitationStandard Rehabilitation | Other | Control-Group, Exo-group |
Primary outcome
The Functional Independence Measure (FIM™)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.
The two minute walk test (2-MWT)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.
3 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
Discharge disposition
Time frame: 4-weeks
The Beck Depression Inventory (BDI)
Time frame: Baseline (Day 1) and at 4-weeks to measure change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Meheroz H Rabadi, MD, MRCPI principal investigator
Affiliate; Oklahoma VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indego Exoskeleton and Standard Rehabilitation in people with Stroke and Weakness of Extremities as Sequela of Stroke, run by University of Oklahoma 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meheroz H Rabadi, MD, MRCPI (405-456-5298, rabadimh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Functional Independence Measure (FIM™) (time frame: Baseline (Day 1) and at 4-weeks to measure change). The study lists 2 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 1 Apr 2026.