StrokeNCT06269367
NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
A study testing NewGait in people with Stroke, run by University of Michigan at 1 site in United States.
Trial summary
An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- NewGait
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 9 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral cortical or subcortical stroke
- Chronic stroke (≥ 6 months) At least 6 months following their first unilateral stroke
- Able to walk independently with/without assistive devices for 5-10 mins (~150m)
- No significant cognitive deficits as determined by the Mini Mental State Examination (MMSE) score (score≥ 22)
Who cannot join
- Cerebellar stroke
- Traumatic or vascular brain injury
- History of unstable heart condition, uncontrolled diabetes/hypertension
- History of a recent lower-extremity trauma or fracture
- History of a recent significant orthopedic or neurological conditions that could limit walking ability (e.g., multiple sclerosis, total knee replacement)
- Documented history of significant spatial neglect
Show all 9Show fewer
- ankle joint contractures or significant spasticity in the lower limbs
- History of a recent Botulinum Toxin (Botox) injection to the lower-extremity muscles (≤ 3 months)
- Pregnant or actively planning to become pregnant (self-reported)- Inability to communicate or unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011
Ann Arbor, Michigan, 48108
About this study
An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices.
Read the detailed description
More than 795,000 individuals suffer from a stroke each year in the United States, making stroke a leading cause of adult disability in the United States and worldwide. More than half of stroke survivors exhibit reduced independence and functional mobility due to stroke-related gait impairments. Despite significant advancements in post-stroke medical care and rehabilitation, current treatments are not successful in optimally restoring gait function after stroke. It is well established that intense, repetitive task-oriented rehabilitation interventions are essential for inducing experience-dependent neuroplasticity (defined as the ability of the nervous system to adapt and optimize its resources through structural and functional changes)-which is a key factor for post-stroke gait recovery. Accordingly, new therapeutic approaches that rely on specialized gait training devices, such as treadmills, robotic devices, and exosuits have been developed. However, these devices are typically expensive, bulky, and not accessible for home use. Moreover, these devices often require uninterrupted power sources, which is a major barrier for rural communities in developing nations. While some lightweight and "low-cost" commercial devices exist, they are not often designed based on multi-user feedback and robust biomechanical data and their clinical utility have not been tested in stroke survivors, thereby limiting usability and effectiveness. Thus, there is a significant unmet clinical need for an effective, affordable, and portable gait mobility/rehabilitation device that is accessible for most stroke survivors. This Phase-I STTR pursues the following specific aims: (1) Identify an optimal NewGait design based on end-user feedback (design sprints) and musculoskeletal modeling to address the needs of stroke rehabilitation, (2) Refine the current prototype using data gathered from design sprints and think aloud technique and perform benchtop testing on the final prototype to validate durability, and (3) Examine short-term gait adaptations and clinical feasibility in stroke survivors by performing a comparative clinical feasibility study in stroke survivors to establish the clinical utility of the NewGait device in comparison with other similar devices. This trial registration is for the third aim only, as the first two aims do not follow under the definition of clinical trial. All devices tested are deemed to be 501(k) exempt devices. The successful completion of this Phase-I STTR will lay the foundation for an evidence-based low-cost gait rehabilitation system that could positively affect the lives of millions of stroke survivors living across the globe.
- Conditions
- Stroke
- Being tested
- NewGait, Control wearable limb orthotic device
- Keywords
- gait training, balance, Stroke survivors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NewGaitOther
wearable limb orthotic device
Control wearable limb orthotic deviceOther
wearable limb orthotic device
| Study group | Role | What they receive |
|---|---|---|
| NewGait | Experimental | Participants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. Receives: Other: NewGait |
| Control | Other | Participants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training. Receives: Other: Control wearable limb orthotic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Changes in gait speed (from baseline) as measured using the 10 Meter Walk Test between the experimental (NewGait) and control conditions. Participants were timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway. In this test, participants walked down a 14 meter walkway, and a stopwatch was used to time how long it took participants to cross the intermediate 10 meter distance. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
Measured: Up to 2 hours
Ankle Muscle Activation
Changes in ankle muscle activation of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. Muscle activation ranges from 0 to no upper limit, and higher activation meant that the muscle was being used more. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
Measured: Up to 2 hours
Secondary outcomes (1)
Changes in Paretic Leg Propulsive Force
Changes in paretic leg propulsive force were measured using ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions. Propulsive force had no upper or lower limit, with a higher number indicating greater propulsion from the paretic limb. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. Results reflect Newton units in force generated divided by Newton units of body weight (N/N) times 100. All measures were obtained on the same day.
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- Participants will be randomly assigned to the two device interventions but will receive both interventions.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Chandramouli Krishnan, University of Michigan
- Investigators
- Chandramouli Krishnan, PT, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269367
- Sponsor's protocol ID
- HUM00226149
- Other IDs
- 1R41HD111289-01
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2024
- Last updated
- 23 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
- ClinicalTrials.gov ID
- NCT06269367
- Acronym / sponsor ID
- HUM00226149
- Conditions
- Stroke
- Keywords
- gait training, balance, Stroke survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Posted 23 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices.
Detailed description
More than 795,000 individuals suffer from a stroke each year in the United States, making stroke a leading cause of adult disability in the United States and worldwide. More than half of stroke survivors exhibit reduced independence and functional mobility due to stroke-related gait impairments. Despite significant advancements in post-stroke medical care and rehabilitation, current treatments are not successful in optimally restoring gait function after stroke. It is well established that intense, repetitive task-oriented rehabilitation interventions are essential for inducing experience-dependent neuroplasticity (defined as the ability of the nervous system to adapt and optimize its resources through structural and functional changes)-which is a key factor for post-stroke gait recovery. Accordingly, new therapeutic approaches that rely on specialized gait training devices, such as treadmills, robotic devices, and exosuits have been developed. However, these devices are typically expensive, bulky, and not accessible for home use. Moreover, these devices often require uninterrupted power sources, which is a major barrier for rural communities in developing nations. While some lightweight and "low-cost" commercial devices exist, they are not often designed based on multi-user feedback and robust biomechanical data and their clinical utility have not been tested in stroke survivors, thereby limiting usability and effectiveness. Thus, there is a significant unmet clinical need for an effective, affordable, and portable gait mobility/rehabilitation device that is accessible for most stroke survivors. This Phase-I STTR pursues the following specific aims: (1) Identify an optimal NewGait design based on end-user feedback (design sprints) and musculoskeletal modeling to address the needs of stroke rehabilitation, (2) Refine the current prototype using data gathered from design sprints and think aloud technique and perform benchtop testing on the final prototype to validate durability, and (3) Examine short-term gait adaptations and clinical feasibility in stroke survivors by performing a comparative clinical feasibility study in stroke survivors to establish the clinical utility of the NewGait device in comparison with other similar devices. This trial registration is for the third aim only, as the first two aims do not follow under the definition of clinical trial. All devices tested are deemed to be 501(k) exempt devices. The successful completion of this Phase-I STTR will lay the foundation for an evidence-based low-cost gait rehabilitation system that could positively affect the lives of millions of stroke survivors living across the globe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the two device interventions but will receive both interventions.
| Arm | Type | Receives |
|---|---|---|
| NewGait | Experimental | Other: NewGaitParticipants will put on the NewGait device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. |
| Control | Other | Other: Control wearable limb orthotic deviceParticipants will put on the Control device and walk on the treadmill and over ground. Participants may receive biofeedback of their gait patterns to engage them in the training. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral cortical or subcortical stroke
- Chronic stroke (≥ 6 months) At least 6 months following their first unilateral stroke
- Able to walk independently with/without assistive devices for 5-10 mins (~150m)
- No significant cognitive deficits as determined by the Mini Mental State Examination (MMSE) score (score≥ 22)
Key exclusion criteria (9 listed)
- Cerebellar stroke
- Traumatic or vascular brain injury
- History of unstable heart condition, uncontrolled diabetes/hypertension
- History of a recent lower-extremity trauma or fracture
- History of a recent significant orthopedic or neurological conditions that could limit walking ability (e.g., multiple sclerosis, total knee replacement)
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 |
|---|---|---|
| NewGaitwearable limb orthotic device | Other | NewGait |
| Control wearable limb orthotic devicewearable limb orthotic device | Other | Control |
Primary outcome
Gait Speed
Time frame: Up to 2 hours
Changes in gait speed (from baseline) as measured using the 10 Meter Walk Test between the experimental (NewGait) and control conditions. Participants were timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway. In this test, participants walked down a 14 meter walkway, and a stopwatch was used to time how long it took participants to cross the intermediate 10 meter distance. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
Ankle Muscle Activation
Time frame: Up to 2 hours
Changes in ankle muscle activation of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. Muscle activation ranges from 0 to no upper limit, and higher activation meant that the muscle was being used more. The baseline measure for the first device was taken immediately prior to the intervention. Participants then wore the first device, and the during-training measure was taken immediately. After this, participants received training with the device for about 15 minutes, following which, the device was removed, and the post-intervention measure was taken immediately for the first device. Participants then rested for 20-30 minutes. This entire process was repeated with the second device. All measures were obtained on the same day.
1 secondary outcome
Changes in Paretic Leg Propulsive Force
Time frame: Up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Chandramouli Krishnan, PT, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NewGait in people with 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 4 inclusion and 9 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 23 Dec 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?
Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Gait Speed (time frame: Up to 2 hours). 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 23 Dec 2025.