WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Innovative Neurotronics

Status

Completed

Conditions

Stroke

Treatments

Other: Ankle-Foot Orthosis (AFO)

Device: WalkAide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01087957

INSTRIDE

Details and patient eligibility

About

To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.

Full description

This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).

Enrollment

495 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patient history of stroke (ischemic and/or hemorrhagic).
Patient is at least 6 months post stroke.
Patient has hemiplegia/hemiparesis.
Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance.
Patient is not currently using Functional Electrical Stimulation for the treatment of footdrop.
Patient is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation on the lower extremity.
Patient is a minimum of 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement).
Patient is a minimum of 90 days post myocardial infarction.
Patient is a minimum of 90 days post stenting procedure (i.e. peripheral, cardiac, carotid, and/or renal).
Patient is a minimum of 6 months post CABG or cardiac valve procedure.
Patient is able to walk at least 10 meters with or without an assist device (excluding an AFO or WalkAide device).
Patient has an initial gait speed > 0.0 m/s and < 0.8 m/s.
Patient has a positive response to peroneal nerve stimulation testing, resulting adequate dorsiflexion of the ankle.
Patient has adequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score >17 within 30 days prior to enrollment.
Patient has completed a full neurological assessment within 30 days prior to enrollment.
Patient is eligible for Medicare or Medicare Choice/Advantage benefits at the time of enrollment
Patient is able and willing to comply with study procedures, including follow-up requirements.
Patient is able and willing to give written informed consent.

Exclusion Criteria

Patient is less than 6-months post stroke.
Patient has inadequate cognitive function to permit reliable completion of evaluation instruments and to correctly use the therapeutic interventions as determined by a Mini-Mental Status test score < 17 within 30 days prior to enrollment.
Patient has ankle joint instability other than foot drop.
Patient is less than 30 days post inpatient or outpatient: stroke, cardiac, pulmonary, or any type of physical rehabilitation on the lower extremity at time of enrollment.
Patient has need for an AFO for stance control of the foot, ankle and/or knee.
Patient has an initial gait speed of 0.8 m/s or greater classified as a full community walker (independent in all home and community activities).
Patient is not able to safely clear toes in swing phase on the involved lower extremity, defined as >-5° plantar flexion, with the device determined at fitting visit.
Patient has been diagnosed with peripheral neuropathy and symptoms obstruct or limit ambulation or participation in study procedures.
Patient has been diagnosed with significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication.
Patient has underlying condition(s) that would limit study participation such as severe hypertonicity resulting in the need for more involved orthotic strategies or excessive dysesthetic pain secondary to neurological involvement.
Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Patient is NYHA Class III or IV.
Patient has malignant skin lesion below the knee on the affected lower extremity.
Patient has history of seizure disorder and on seizure medications.
Patient has aphasia, defined as incapacity to verbalize commands.
Patient has Beck Depression Index score of > 29 indicating severe depression.
Patient has a life expectancy less than 12 months.
Patient has existing electrical stimulation devices (ICD, Pacemaker, Spinal Stimulation, TENS).
Patient is less than 6 months free from Botulinum Toxin (Botox) injection in the lower extremity.
Patient has baclofen pump with unstable dosing in the last 3 months.
Patient is unable or unwilling to comply with study procedures, including follow-up requirements.
Patient is participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results.
Patient is unable or unwilling to give written informed consent.