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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41HD111289-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NewGait | Other | wearable limb orthotic device |
| |
| Control wearable limb orthotic device |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Paretic Leg Loading (i.e., Vertical Ground Reaction Force) | Changes in paretic leg loading were measured using vertical ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions. | Up to 2 hours |
| Changes in Other Lower Extremity Muscle Activation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chandramouli Krishnan, PT, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011 | Ann Arbor | Michigan | 48108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NewGait/Control | 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. NewGait: wearable limb orthotic device Following this, participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. Control wearable limb orthotic device: wearable limb orthotic device |
| FG001 | Control/NewGait | Participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. Control wearable limb orthotic device: wearable limb orthotic device Following this, 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. NewGait: wearable limb orthotic device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I |
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| |||||||||||||||||||||
| Phase II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NewGait/Control | 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. NewGait: wearable limb orthotic device Following this, participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. Control wearable limb orthotic device: wearable limb orthotic device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was only analyzed on participants who completed the study. | Posted | Mean | Standard Error | meters per second | Up to 2 hours |
|
Up to 2 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NewGait | 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. NewGait: wearable limb orthotic device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chandramouli Krishnan | University of Michigan | (734) 936-4031 | mouli@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2024 | Dec 4, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2024 | Dec 18, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants will be randomly assigned to the two device interventions but will receive both interventions.
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| Other |
wearable limb orthotic device |
|
| Up to 2 hours |
Changes in lower extremity muscle activation as measured using surface electromyography between the experimental (NewGait) and control conditions. |
| Up to 2 hours |
| Muscle Coordination | Changes in ankle muscle coordination of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. | Up to 2 hours |
| NOT COMPLETED |
|
| BG001 | Control/NewGait | Participants will put on the Control device and walk on the treadmill and overground. Participants may receive biofeedback of their gait patterns to engage them in the training. Control wearable limb orthotic device: wearable limb orthotic device Following this, 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. NewGait: wearable limb orthotic device |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Mini-mental state examination score | Measure of cognitive function on a scale of 0 to 30, with higher scores representing greater cognitive function. | Mean | Standard Deviation | units on a scale |
|
| Time since stroke | Mean | Standard Deviation | months |
|
| Lower extremity Fugl-Meyer score | Measure of lower extremity impairment post-stroke on a scale from 0 to 34, with a higher score representing less impairment. | Mean | Standard Deviation | units on a scale |
|
| Gait speed | Measure of preferred walking speed from 0 to no upper limit, with a higher value indicating faster walking speed. | Mean | Standard Deviation | meters per second |
|
| OG000 | NewGait | 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. NewGait: wearable limb orthotic device |
| OG001 | Control | 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. Control wearable limb orthotic device: wearable limb orthotic device |
|
|
|
| Primary | 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. | Data was only analyzed on participants who completed the study. | Posted | Mean | Standard Error | percentage of maximum muscle activation | Up to 2 hours |
|
|
|
|
| Secondary | 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. | Data was only analyzed on participants who completed the study. | Posted | Mean | Standard Error | percentage of body weight (N/N) | Up to 2 hours |
|
|
|
|
| Other Pre-specified | Changes in Paretic Leg Loading (i.e., Vertical Ground Reaction Force) | Changes in paretic leg loading were measured using vertical ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions. | Not Posted | Up to 2 hours | Participants |
| Other Pre-specified | Changes in Other Lower Extremity Muscle Activation | Changes in lower extremity muscle activation as measured using surface electromyography between the experimental (NewGait) and control conditions. | Not Posted | Up to 2 hours | Participants |
| Other Pre-specified | Muscle Coordination | Changes in ankle muscle coordination of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. | Not Posted | Up to 2 hours | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 14 |
| 20 |
| EG001 | Control | 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. Control wearable limb orthotic device: wearable limb orthotic device | 0 | 20 | 0 | 20 | 14 | 20 |
| Muscle/Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Medial Gastrocnemius, Post-intervention |
|
| Lateral Soleus, Baseline |
|
| Lateral Soleus, During training |
|
| Lateral Soleus, Post-intervention |
|
| Tibialis Anterior, Baseline |
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| Tibialis Anterior, During training |
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| Tibialis Anterior, Post-intervention |
|
| Post-intervention |
|