Stroke
Conditions
Keywords
gait training, balance, Stroke survivors
Brief 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. 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.
Interventions
OTHERNewGait
wearable limb orthotic device
OTHERControl wearable limb orthotic device
wearable limb orthotic device
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to the two device interventions but will receive both interventions.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Paretic Leg Propulsive Force | Up to 2 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Paretic Leg Loading (i.e., Vertical Ground Reaction Force) | Up to 2 hours | 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. |
| Changes in Other Lower Extremity Muscle Activation | Up to 2 hours | Changes in lower extremity muscle activation as measured using surface electromyography between the experimental (NewGait) and control conditions. |
| Muscle Coordination | Up to 2 hours | Changes in ankle muscle coordination of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase I | Could not continue study for personal reasons. | 1 | 0 |
| Phase I | Unable to perform study procedures | 0 | 1 |
Baseline characteristics
| Characteristic | Control/NewGait | Total | NewGait/Control |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 7.2 | 64.1 years STANDARD_DEVIATION 7.3 | 63.5 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gait speed | 0.9 meters per second STANDARD_DEVIATION 0.3 | 0.9 meters per second STANDARD_DEVIATION 0.4 | 0.9 meters per second STANDARD_DEVIATION 0.4 |
| Lower extremity Fugl-Meyer score | 22.3 units on a scale STANDARD_DEVIATION 4.3 | 22.1 units on a scale STANDARD_DEVIATION 3.8 | 21.8 units on a scale STANDARD_DEVIATION 3.4 |
| Mini-mental state examination score | 28.0 units on a scale STANDARD_DEVIATION 1.9 | 28.5 units on a scale STANDARD_DEVIATION 1.9 | 28.9 units on a scale STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
| Time since stroke | 136.2 months STANDARD_DEVIATION 94.9 | 119.3 months STANDARD_DEVIATION 75.2 | 102.3 months STANDARD_DEVIATION 47.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 14 / 20 | 14 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Up to 2 hours
Population: Data was only analyzed on participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NewGait | Ankle Muscle Activation | Medial Gastrocnemius, Baseline | 75.29 percentage of maximum muscle activation | Standard Error 15.68 |
| NewGait | Ankle Muscle Activation | Medial Gastrocnemius, During training | 62.41 percentage of maximum muscle activation | Standard Error 14.61 |
| NewGait | Ankle Muscle Activation | Medial Gastrocnemius, Post-intervention | 67.77 percentage of maximum muscle activation | Standard Error 15.26 |
| NewGait | Ankle Muscle Activation | Lateral Soleus, Baseline | 68.61 percentage of maximum muscle activation | Standard Error 14.78 |
| NewGait | Ankle Muscle Activation | Lateral Soleus, During training | 72.72 percentage of maximum muscle activation | Standard Error 14.22 |
| NewGait | Ankle Muscle Activation | Lateral Soleus, Post-intervention | 68.66 percentage of maximum muscle activation | Standard Error 15.99 |
| NewGait | Ankle Muscle Activation | Tibialis Anterior, Baseline | 30.87 percentage of maximum muscle activation | Standard Error 2.93 |
| NewGait | Ankle Muscle Activation | Tibialis Anterior, During training | 28.04 percentage of maximum muscle activation | Standard Error 3.87 |
| NewGait | Ankle Muscle Activation | Tibialis Anterior, Post-intervention | 25.71 percentage of maximum muscle activation | Standard Error 4.04 |
| Control | Ankle Muscle Activation | Lateral Soleus, During training | 72.24 percentage of maximum muscle activation | Standard Error 13.49 |
| Control | Ankle Muscle Activation | Medial Gastrocnemius, Baseline | 72.98 percentage of maximum muscle activation | Standard Error 15.68 |
| Control | Ankle Muscle Activation | Tibialis Anterior, During training | 21.55 percentage of maximum muscle activation | Standard Error 3.87 |
| Control | Ankle Muscle Activation | Medial Gastrocnemius, During training | 66.77 percentage of maximum muscle activation | Standard Error 15.05 |
| Control | Ankle Muscle Activation | Lateral Soleus, Post-intervention | 64.05 percentage of maximum muscle activation | Standard Error 15.99 |
| Control | Ankle Muscle Activation | Medial Gastrocnemius, Post-intervention | 75.46 percentage of maximum muscle activation | Standard Error 15.12 |
| Control | Ankle Muscle Activation | Tibialis Anterior, Post-intervention | 30.02 percentage of maximum muscle activation | Standard Error 3.02 |
| Control | Ankle Muscle Activation | Lateral Soleus, Baseline | 68.43 percentage of maximum muscle activation | Standard Error 14.41 |
| Control | Ankle Muscle Activation | Tibialis Anterior, Baseline | 30.08 percentage of maximum muscle activation | Standard Error 3.83 |
p-value: >0.299ANOVA
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.
Time frame: Up to 2 hours
Population: Data was only analyzed on participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NewGait | Gait Speed | Baseline | 0.90 meters per second | Standard Error 0.09 |
| NewGait | Gait Speed | During training | 0.88 meters per second | Standard Error 0.08 |
| NewGait | Gait Speed | Post-intervention | 0.91 meters per second | Standard Error 0.09 |
| Control | Gait Speed | During training | 0.87 meters per second | Standard Error 0.08 |
| Control | Gait Speed | Post-intervention | 0.92 meters per second | Standard Error 0.09 |
| Control | Gait Speed | Baseline | 0.92 meters per second | Standard Error 0.08 |
p-value: 0.894ANOVA
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.
Time frame: Up to 2 hours
Population: Data was only analyzed on participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NewGait | Changes in Paretic Leg Propulsive Force | During training | 11.92 percentage of body weight (N/N) | Standard Error 1.86 |
| NewGait | Changes in Paretic Leg Propulsive Force | Post-intervention | 8.70 percentage of body weight (N/N) | Standard Error 1.31 |
| NewGait | Changes in Paretic Leg Propulsive Force | Baseline | 8.22 percentage of body weight (N/N) | Standard Error 1.26 |
| Control | Changes in Paretic Leg Propulsive Force | Baseline | 8.03 percentage of body weight (N/N) | Standard Error 1.26 |
| Control | Changes in Paretic Leg Propulsive Force | During training | 11.36 percentage of body weight (N/N) | Standard Error 1.86 |
| Control | Changes in Paretic Leg Propulsive Force | Post-intervention | 9.00 percentage of body weight (N/N) | Standard Error 1.31 |
p-value: 0.469ANOVA
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.
Time frame: 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.
Time frame: Up to 2 hours
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.
Time frame: Up to 2 hours