N/A
N=45
Ankle Robot to Reduce Foot Drop in Stroke
Stroke · Foot Drop
Bottom Line
View on ClinicalTrials.gov: NCT02483676 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Gait Velocity During Self-selected Overground Walking — 0.48; 0.48; 0.54; 0.56 CM/SEC
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treadmill plus anklebot (Device); Treadmill only (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Velocity During Self-selected Overground Walking |
0.48; 0.48; 0.54; 0.56; 0.53; 0.55 | — |
| PRIMARY Anterior-posterior Propulsion Forces of Paretic Side During Gait |
2.22; 2.22; 4.92; 3.03; 6.06; 4.14 | — |
| PRIMARY Peak Dorsiflexion Angle During Swing Phase of Gait |
3.95; 3.95; 4.84; 4.24; 4.34; 3.27 | — |
| PRIMARY Postural Sway Areas During Quiet Standing |
1.16; 1.16; 1.51; 1.33; 1.44; 1.13 | — |
| PRIMARY Ratio of Asymmetric Loading in Quiet Standing |
— | — |
| PRIMARY Peak Paretic Push Off Forces During Gait Initiation |
64.7; 64.7; 63.5; 62.8; 65.4; 69.8 | — |
Summary
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Eligibility Criteria
Inclusion Criteria
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Exclusion Criteria
- Cardiac history of:
- Unstable angina
- Recent ( 160/100 mmHg on two assessments)
- Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
- Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
Data sourced from ClinicalTrials.gov (NCT02483676). 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.