Clinical trial NCT06269367: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
Official title: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: gait training
balance
Stroke survivors
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomly assigned to the two device interventions but will receive both interventions.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait speed
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
measure: Ankle Muscle Activation
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Secondary outcomes:
measure: Changes in paretic leg propulsive force
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Other outcomes:
measure: Changes in paretic leg loading (i.e., vertical ground reaction force)
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
measure: Changes in other lower extremity muscle activation
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
measure: Muscle Coordination
timeFrame: Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Locations:
city: Ann Arbor
country: United States
facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chandramouli Krishnan, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: