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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics
ClinicalTrials.gov Identifier:
NCT01087957
First received: March 15, 2010
Last updated: February 21, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention
Stroke
Device: WalkAide
Other: Ankle-Foot Orthosis (AFO)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

Resource links provided by NLM:


Further study details as provided by Innovative Neurotronics:

Primary Outcome Measures:
  • • Improved ambulation status, specific to increase in gait velocity (m/s), • Improved activities of daily living, rate of device related Serious Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 496
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ankle-Foot Orthosis (AFO)
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Other: Ankle-Foot Orthosis (AFO)
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Active Comparator: WalkAide
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
Device: WalkAide
Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 has not participated in or 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. This will be 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. This will be 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. 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.
  • The patient has underlying condition(s) that would limit study participation.
  • Severe hypertonicity resulting in the need for more involved orthotic strategies.
  • Excessive dysethetic 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087957

  Show 29 Study Locations
Sponsors and Collaborators
Innovative Neurotronics
Investigators
Principal Investigator: Francois Bethoux, M.D. The Cleveland Clinic
  More Information

Publications:
Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT01087957     History of Changes
Other Study ID Numbers: INSTRIDE
Study First Received: March 15, 2010
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014