Stroke Clinical Trial
Official title:
NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011 | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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. |
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