StrokeNCT07616167
This Study Evaluates the Use of a Data-driven Lower Limb Exoskeleton Controller for Stroke Rehabilitation.
A study of Stroke, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort 1: Able-Bodied Participants (Initial Validation)
- Healthy young adults.
- No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
- Able to walk independently without assistive devices.
- Cohort 2: Stroke Survivors (Clinical Efficacy Pilot)
- Individuals with a documented history of chronic stroke.
Show all 9Show fewer
- Persistent unilateral lower-limb motor impairment resulting in a pathological gait pattern (heterogeneous gait deficits).
- Stable medical condition allowing for participation in intensive physical rehabilitation tasks.
- Able to provide informed consent.
Who cannot join
- Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
- Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
- Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
- Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
- Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).
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
Rehabilitation Laboratory in the Ford Robotics Building on the University of Michigan North Campus
Ann Arbor, Michigan, 48109
About this study
Official title: From Stroke Rehabilitation to Independence: An Impairment-Aware Control Framework for Adaptive Exoskeleton Assistance
The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. .
The main questions it aims to answer are:
Read more
Can the new control software safely use sensors and machine learning to predict and instantly adapt to a user's specific walking needs?
Does training with a robotic device driven by this new adaptive control framework improve walking speed and overall mobility in stroke survivors?
Researchers will compare a lower-limb orthosis operating under the new "smart" control software (which adapts to the user's impairment) to the same device operating under a standard, non-adaptive controller (which uses rigid or fixed assistance) to see if the new control approach leads to greater improvements in walking ability.
Participants will:
Walk on treadmills, flat walkways, or stairs while wearing a robotic leg orthosis driven by the different control software systems being tested.
Wear small tracking tools (like reflective motion-capture markers and muscle activity sensors) so researchers can precisely measure how their movements interact with each control program.
Complete standard walking tests to measure their walking speed and overall mobility under each software condition.
- Conditions
- Stroke
- Being tested
- Unified Control Framework for Lower-Limb Powered Orthosis, Conventional Robotic Controller
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Control Framework for Lower-Limb Powered OrthosisDevice
An AI-driven, machine learning-based control software integrated into a wearable lower-limb powered orthosis. The system utilizes a Bayesian Neural Network (BNN) to analyze a user's pathological walking patterns (kinematics) in real-time via onboard sensors. Based on this real-time performance, the device dynamically modulates its physical assistance along a seamless continuum. It automatically transitions between stiff corrective guidance (position-based gait training) when the user struggles, and compliant, volitional torque support (torque-based assistance) as the user's independent walking ability improves.
Conventional Robotic ControllerDevice
A standard control paradigm for lower-limb powered orthoses that provides non-adaptive physical assistance during gait training. Depending on the trial block, the device operates in one of two static modalities: either rigid position-based gait training (GT) that physically guides the patient's limbs through a fixed, predetermined trajectory regardless of effort, or torque-based volitional augmentation (VA) that proportionally amplifies existing muscle output or ground reaction forces. Unlike the experimental intervention, this controller cannot interpret kinematics in real-time or dynamically modulate assistance along a continuous spectrum based on the user's instantaneous performance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Training with the new "unified control framework" (the smart, adaptive robotic exoskeleton). Receives: Device: Unified Control Framework for Lower-Limb Powered Orthosis |
| Active Comparator Arm | Active comparator | Training with a "conventional controller" (the standard robotic exoskeleton controller). Receives: Device: Conventional Robotic Controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
A standardized clinical assessment used to determine short-distance walking speed over a 10-meter course. This metric evaluates the preliminary clinical efficacy of the unified control framework compared to the conventional controller in chronic stroke survivors.
Measured: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
Functional Mobility and Balance
A clinical performance-based measure used to assess dynamic balance, turning agility, and functional mobility. The test measures the time (in seconds) taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.
Measured: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
Secondary outcomes (3)
Acute Within-Session Changes in Spatial Gait Symmetry
Gait symmetry evaluated using the step length symmetry index (SI), calculated from lower-limb kinematics recorded by the exoskeleton's onboard joint encoders and/or motion capture data. This metric evaluates the immediate corrective effects on walking patterns. An SI of 0% represents perfect symmetry.
Measured: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Ground Reaction Force Symmetry
Force symmetry evaluated using the peak vertical ground reaction force ratio between the paretic and non-paretic limbs, measured via the exoskeleton's instrumented insoles and/or force plates. This evaluates the immediate impact of the control framework on weight-bearing symmetry. Data are expressed as a dimensionless ratio, where a value of 1.0 indicates perfect symmetry between limbs. Force is measured in units of Newtons.
Measured: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Joint Range of Motion
Measurement of the peak angular displacement of the knee, hip and ankle joints (in degrees) during the sagittal plane gait cycle, captured by the exoskeleton's onboard joint encoders and/or a motion capture system.
Measured: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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 University of MichiganThe 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert D Gregg, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616167
- Sponsor's protocol ID
- HUM00287262
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Stroke Rehabilitation to Independence: An Impairment-Aware Control Framework for Adaptive Exoskeleton Assistance
- ClinicalTrials.gov ID
- NCT07616167
- Acronym / sponsor ID
- HUM00287262
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jun 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.
The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. .
The main questions it aims to answer are:
Can the new control software safely use sensors and machine learning to predict and instantly adapt to a user's specific walking needs?
Does training with a robotic device driven by this new adaptive control framework improve walking speed and overall mobility in stroke survivors?
Researchers will compare a lower-limb orthosis operating under the new "smart" control software (which adapts to the user's impairment) to the same device operating under a standard, non-adaptive controller (which uses rigid or fixed assistance) to see if the new control approach leads to greater improvements in walking ability.
Participants will:
Walk on treadmills, flat walkways, or stairs while wearing a robotic leg orthosis driven by the different control software systems being tested.
Wear small tracking tools (like reflective motion-capture markers and muscle activity sensors) so researchers can precisely measure how their movements interact with each control program.
Complete standard walking tests to measure their walking speed and overall mobility under each software condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Unified Control Framework for Lower-Limb Powered OrthosisTraining with the new "unified control framework" (the smart, adaptive robotic exoskeleton). |
| Active Comparator Arm | Active comparator | Device: Conventional Robotic ControllerTraining with a "conventional controller" (the standard robotic exoskeleton controller). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cohort 1: Able-Bodied Participants (Initial Validation)
- Healthy young adults.
- No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
- Able to walk independently without assistive devices.
- Cohort 2: Stroke Survivors (Clinical Efficacy Pilot)
Key exclusion criteria (5 listed)
- Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
- Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
- Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
- Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
- Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).
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 |
|---|---|---|
| Unified Control Framework for Lower-Limb Powered OrthosisAn AI-driven, machine learning-based control software integrated into a wearable lower-limb powered orthosis. The system utilizes a Bayesian Neural Network (BNN) to analyze a user's pathological walking patterns (kinematics) in real-time via onboard sensors. Based on this real-time performance, the device dynamically modulates its physical assistance along a seamless continuum. It automatically transitions between stiff corrective guidance (position-based gait training) when the user struggles, and compliant, volitional torque support (torque-based assistance) as the user's independent walking ability improves. | Device | Experimental Arm |
| Conventional Robotic ControllerA standard control paradigm for lower-limb powered orthoses that provides non-adaptive physical assistance during gait training. Depending on the trial block, the device operates in one of two static modalities: either rigid position-based gait training (GT) that physically guides the patient's limbs through a fixed, predetermined trajectory regardless of effort, or torque-based volitional augmentation (VA) that proportionally amplifies existing muscle output or ground reaction forces. Unlike the experimental intervention, this controller cannot interpret kinematics in real-time or dynamically modulate assistance along a continuous spectrum based on the user's instantaneous performance. | Device | Active Comparator Arm |
Primary outcome
Walking Speed
Time frame: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
A standardized clinical assessment used to determine short-distance walking speed over a 10-meter course. This metric evaluates the preliminary clinical efficacy of the unified control framework compared to the conventional controller in chronic stroke survivors.
Functional Mobility and Balance
Time frame: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).
A clinical performance-based measure used to assess dynamic balance, turning agility, and functional mobility. The test measures the time (in seconds) taken for a participant to rise from a chair, walk 3 meters, turn around, walk back, and sit down.
3 secondary outcomes
Acute Within-Session Changes in Spatial Gait Symmetry
Time frame: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Ground Reaction Force Symmetry
Time frame: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
Acute Within-Session Changes in Joint Range of Motion
Time frame: Baseline (Week 0) and weekly during the 12 training sessions across each 4-week intervention period.
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 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stroke, run by University of Michigan 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 9 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: opening soon, as of the sponsor's last update on 1 Jun 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?
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?
Walking Speed (time frame: Baseline (Week 0), Post-Intervention Phase 1 (Week 4), Post-Washout / Pre-Intervention Phase 2 (Week 8), and Post-Intervention Phase 2 (Week 12).). 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 Jun 2026.