StrokeNCT07356011
Exoskeleton for Balance
A study testing No Exoskeleton, Exoskeleton (zero impedance) and Exoskeleton (low impedance) in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- No Exoskeleton, Exoskeleton (zero impedance) and Exoskeleton (low impedance)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2026to 1 Jun 2027
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a stroke at least 6 months prior to participation
- Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
- At least 21 years of age
- Self-reported experience of a fall in the previous year, and/or a fear of falling
- Gait speed of at least 0.2 m/s
- Ability to walk on a treadmill without a cane or walker
- Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence)
- Provision of informed consent
Who cannot join
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological orders or dementia
- Legal blindness or severe visual impairment
- Presence of neglect
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern
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
Medical University of South Carolina
Charleston, South Carolina, 29425
Jesse C. Dean, PhD, 8437929566, deaje@musc.edu
Jesse C Dean, PhD
About this study
Official title: Improving Mediolateral Walking Balance With an Assistive Exoskeleton
Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.
Read the detailed description
Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.
- Conditions
- Stroke
- Being tested
- No Exoskeleton, Exoskeleton (zero impedance), Exoskeleton (low impedance), Exoskeleton (medium impedance), Exoskeleton (high impedance)
- Keywords
- walking, balance, exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No ExoskeletonDevice
The participant will not wear an exoskeleton
Exoskeleton (zero impedance)Device
The participant will wear an exoskeleton with zero impedance
Exoskeleton (low impedance)Device
The participant will wear an exoskeleton with low joint impedance
Exoskeleton (medium impedance)Device
The participant will wear an exoskeleton with medium joint impedance
Exoskeleton (high impedance)Device
The participant will wear an exoskeleton with high impedance
| Study group | Role | What they receive |
|---|---|---|
| xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) | Experimental | Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance. Receives: Device: No Exoskeleton; Device: Exoskeleton (zero impedance); Device: Exoskeleton (low impedance); Device: Exoskeleton (medium impedance); Device: Exoskeleton (high impedance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 2, anticipated average 1 week
Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Secondary outcomes (17)
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 2, anticipated average 1 week
Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Measured: Visit 2, anticipated average 1 week
Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Measured: Visit 2, anticipated average 1 week
Rating of Perceived Stability (RPS) during unperturbed walking
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Measured: Visit 2, anticipated average 1 week
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with speed perturbations
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with speed perturbations
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with speed perturbations
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Measured: Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with vision perturbations
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with vision perturbations
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with vision perturbations
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Measured: Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during mediolateral pull perturbations
Mediolateral pelvis displacement will be quantified at the start of each step, and mediolateral foot placement relative to the pelvis will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with mediolateral pull perturbations
Average gluteus medius EMG activity will be calculated during the stance phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with mediolateral pull perturbations
Average gluteus medius EMG activity will be calculated during the swing phase of walking. This will be calculated for each leg independently.
Measured: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with mediolateral pull perturbations
This patient reported outcome measure uses a validated scale for participants to self-report their perceived balance while walking.
Measured: Visit 4, anticipated average 1 year
Change in mediolateral foot placement (cm) during pull perturbations relative to unperturbed steps
The change in mediolateral foot placement locations between steps with and without pull perturbations will be calculated. This will be calculated separately for steps taken with each leg.
Measured: Visit 4, anticipated average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start6 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (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 Medical University of South CarolinaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will experience the same series of experimental sessions. Within individual sessions, the order in which different exoskeleton conditions are tested will be randomized.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Jesse Dean, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356011
- Sponsor's protocol ID
- Pro00135871
- Other IDs
- REGE22000170
- Status last verified
- May 2026
- First submitted
- 8 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mediolateral Walking Balance With an Assistive Exoskeleton
- ClinicalTrials.gov ID
- NCT07356011
- Acronym / sponsor ID
- Pro00135871
- Conditions
- Stroke
- Keywords
- walking, balance, exoskeleton
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 Jan 2026 (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.
Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.
Detailed description
Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will experience the same series of experimental sessions. Within individual sessions, the order in which different exoskeleton conditions are tested will be randomized.
| Arm | Type | Receives |
|---|---|---|
| xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) | Experimental | Device: No Exoskeleton, Device: Exoskeleton (zero impedance), Device: Exoskeleton (low impedance), Device: Exoskeleton (medium impedance), Device: Exoskeleton (high impedance)Participants in this arm will walk on a treadmill under several conditions. In one condition, they will not wear the exoskeleton. In other conditions, the exoskeleton will be set to zero, low, medium, or high impedance. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Evidence of a stroke at least 6 months prior to participation
- Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
- At least 21 years of age
- Self-reported experience of a fall in the previous year, and/or a fear of falling
- Gait speed of at least 0.2 m/s
Key exclusion criteria (8 listed)
- Resting blood pressure higher than 220/110 mm Hg
- History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological orders or dementia
- Legal blindness or severe visual impairment
- Presence of neglect
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 |
|---|---|---|
| No ExoskeletonThe participant will not wear an exoskeleton | Device | xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) |
| Exoskeleton (zero impedance)The participant will wear an exoskeleton with zero impedance | Device | xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) |
| Exoskeleton (low impedance)The participant will wear an exoskeleton with low joint impedance | Device | xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) |
| Exoskeleton (medium impedance)The participant will wear an exoskeleton with medium joint impedance | Device | xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) |
| Exoskeleton (high impedance)The participant will wear an exoskeleton with high impedance | Device | xoskeleton Assistance Conditions (No Exoskeleton, Zero, Low, Medium, High Impedance) |
Primary outcome
Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking
Time frame: Visit 2, anticipated average 1 week
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations
Time frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations
Time frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations
Time frame: Visit 4, anticipated average 1 year
Mediolateral pelvis displacement will be quantified at the start of each step, and step width will be calculated at the end of each step. Across all steps, the partial correlation between these two metrics will be calculated - accounting for the mediolateral pelvis velocity. This will be done for steps taken with each leg independently.
17 secondary outcomes
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking)
Time frame: Visit 2, anticipated average 1 week
Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking
Time frame: Visit 2, anticipated average 1 week
Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking
Time frame: Visit 2, anticipated average 1 week
Rating of Perceived Stability (RPS) during unperturbed walking
Time frame: Visit 2, anticipated average 1 week
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with speed perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with speed perturbations
Time frame: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with speed perturbations
Time frame: Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with vision perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with vision perturbations
Time frame: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with vision perturbations
Time frame: Visit 4, anticipated average 1 year
Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during mediolateral pull perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during stance phase (surface EMG) with mediolateral pull perturbations
Time frame: Visit 4, anticipated average 1 year
Average gluteus medius activity during swing phase (surface EMG) with mediolateral pull perturbations
Time frame: Visit 4, anticipated average 1 year
Rating of Perceived Stability (RPS) with mediolateral pull perturbations
Time frame: Visit 4, anticipated average 1 year
Change in mediolateral foot placement (cm) during pull perturbations relative to unperturbed steps
Time frame: Visit 4, anticipated average 1 year
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 12 May 2026.
- Individual participant dataSharing planned: Yes. All collected IPD that underlie results in a publication will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Exoskeleton, Exoskeleton (zero impedance) and Exoskeleton (low impedance) in people with Stroke, run by Medical University of South Carolina 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 8 inclusion and 8 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 12 May 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. 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 Jesse C. Dean, PhD (8437929566, deaje@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking (time frame: Visit 2, anticipated average 1 week). The study lists 4 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 12 May 2026.