N/A
N=10
Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT06459401 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Immediate Change in Walking Speed — 0.01; 0.03 meters per second (m/s)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Propulsion Neuroprosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Change in Walking Speed |
0.00; 0.03 | 0.131 |
| PRIMARY Immediate Change in Paretic Propulsion |
-0.36; 1.41 | 0.001 sig |
| PRIMARY Immediate Change in Propulsion Symmetry |
-2.13; 1.19 | 0.017 sig |
| PRIMARY Immediate Change in Walking Speed |
0.00; 0.03 | 0.131 |
| PRIMARY Immediate Change in Paretic Propulsion |
-0.36; 1.41 | 0.001 sig |
| PRIMARY Immediate Change in Propulsion Symmetry |
-2.13; 1.19 | 0.017 sig |
| PRIMARY Immediate Change in Walking Speed |
0.00; 0.03 | 0.131 |
| PRIMARY Immediate Change in Paretic Propulsion |
-0.36; 1.41 | 0.001 sig |
| PRIMARY Immediate Change in Propulsion Symmetry |
-2.13; 1.19 | 0.017 sig |
| PRIMARY Immediate Change in Walking Speed |
0.00; 0.03 | 0.131 |
| PRIMARY Immediate Change in Paretic Propulsion |
-0.36; 1.41 | 0.001 sig |
| PRIMARY Immediate Change in Propulsion Symmetry |
-2.13; 1.19 | 0.017 sig |
| PRIMARY Walking Speed at Non-Preferred Timing |
1.30; 1.30 | 0.874 |
| PRIMARY Paretic Propulsion at Non-Preferred Timing |
12.19; 11.83 | 0.345 |
| PRIMARY Propulsion Symmetry at Non-Preferred Timing |
32.2; 30.0 | 0.024 sig |
| PRIMARY Walking Speed at Preferred Timing |
1.31; 1.34 | 0.044 sig |
| PRIMARY Paretic Propulsion at Preferred Timing |
11.87; 13.28 | 0.017 sig |
| PRIMARY Propulsion Symmetry at Preferred Timing |
31.8; 33.0 | 0.372 |
| PRIMARY Unassisted Fast Walking Speed |
1.24; 1.38 | 0.001 sig |
| PRIMARY Unassisted Paretic Propulsion at Fast Speed |
11.20; 13.44 | 0.043 sig |
| PRIMARY Unassisted Propulsion Symmetry at Fast Speed |
28.7; 33.2 | 0.041 sig |
| PRIMARY Unassisted Comfortable Walking Speed |
0.93; 1.06 | 0.013 sig |
| PRIMARY Unassisted Paretic Propulsion at Comfortable Speed |
8.50; 10.12 | 0.012 sig |
| PRIMARY Unassisted Propulsion Symmetry at Comfortable Speed |
28.4; 33.2 | 0.036 sig |
| SECONDARY Onset Timing of Plantarflexor Neurostimulation |
46.9; 63.7 | — |
| SECONDARY Preferred Neurostimulation Timing |
5; 5 | — |
| SECONDARY Dorsiflexion Angle (No Dorsiflexor Impairment) |
4.50; 5.15; 5.14 | — |
| SECONDARY Dorsiflexion Angle (With Dorsiflexor Impairment) |
-3.61; 0.13; -1.03 | — |
| SECONDARY Immediate Change in Dorsiflexion Angle |
1.48; 1.46 | 0.962 |
| SECONDARY Immediate Change in Plantarflexor Power |
0.13; 0.27 | 0.146 |
| SECONDARY Dorsiflexion Angle at Non-Preferred Timing |
2.16; 3.64 | 0.152 |
| SECONDARY Plantarflexor Power at Non-Preferred Timing |
1.88; 2.00 | 0.153 |
| SECONDARY Dorsiflexion Angle at Preferred Timing |
1.83; 3.29 | 0.155 |
| SECONDARY Plantarflexor Power at Preferred Timing |
1.84; 2.11 | 0.004 sig |
| SECONDARY Unassisted Dorsiflexion Angle at Fast Speed |
2.85; 0.66 | 0.014 sig |
| SECONDARY Unassisted Plantarflexor Power at Fast Speed |
1.78; 1.98 | 0.350 |
| SECONDARY Unassisted Dorsiflexion Angle at Comfortable Speed |
2.07; 0.27 | 0.052 |
| SECONDARY Unassisted Plantarflexor Power at Comfortable Speed |
1.25; 1.39 | 0.221 |
Summary
This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of a stroke event occurring at least 6 months ago
- Observable gait deficits
- Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended
- Ability to follow a 3-step command
- Resting heart rate between 40-100 bpm
- Resting blood pressure between 90/60 and 170/90 mmHg
- NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- HIPAA Authorization to allow communication with healthcare provider
- Medical clearance by a physician
Exclusion Criteria
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by electrical stimulation
- Metal implants directly under the stimulation sites
- Pressure ulcers or skin wounds located near human-device interface sites
- More than 2 unexplained falls in the previous month
Data sourced from ClinicalTrials.gov (NCT06459401). 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.