N/A
Completed N=20
NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations)
Source: ClinicalTrials.gov NCT06269367 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Gait Speed — 0.90; 0.92; 0.88; 0.87 meters per second — p=0.894
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Speed |
0.90; 0.92; 0.88; 0.87; 0.91; 0.92 | 0.894 |
| PRIMARY Ankle Muscle Activation |
75.29; 72.98; 62.41; 66.77; 67.77; 75.46 | >0.299 |
| SECONDARY Changes in Paretic Leg Propulsive Force |
8.22; 8.03; 11.92; 11.36; 8.70; 9.00 | 0.469 |
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
Data sourced from ClinicalTrials.gov (NCT06269367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.