Ankle Robot to Reduce Foot Drop in Stroke

Completed · Not applicable

Conditions studied: Stroke, Foot Drop

In brief

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.

Key facts

Study ID

NCT02483676

Run by

VA Office of Research and Development

People needed

45

Starts

2015-09-01

Expected to finish

2019-06-30

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Cardiac history of:
• Unstable angina
• Recent (< 3 months) myocardial infarction
• Congestive heart failure (NYHA category II or higher)
• Hemodynamic valvular dysfunction
• Hypertension that is a contraindication for a bout of treadmill training (>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

Where it is running

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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