NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)

Stroke Clinical Trial

Official title:

NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269367
• Other study ID #: HUM00226149
• Secondary ID: 1R41HD111289-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Chandramouli Krishnan, PT, PhD
• Phone: 7349364031
• Email: mouli[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• NewGait
wearable limb orthotic device
• Control wearable limb orthotic device
wearable limb orthotic device

Locations

Country	Name	City	State
United States	Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in paretic leg loading (i.e., vertical ground reaction force)	Changes in paretic leg loading will be measured using vertical ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Other	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.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Other	Muscle Coordination	Changes in ankle muscle coordination of the leg muscles as measured using surface electromyography between the experimental (NewGait) and control conditions.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
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 will be timed during the 10 Meter Walk Test to determine their self-selected gait speed while walking overground in a hallway.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
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.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.
Secondary	Changes in paretic leg propulsive force	Changes in paretic leg propulsive force will be measured using ground reaction forces obtained from force sensors during walking between the experimental (NewGait) and control conditions.	Baseline and post-intervention measurements are taken on the same day, within the first few minutes up to one hour after training.