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: April 14, 2014
Last verified: April 2014

March 15, 2010
April 14, 2014
March 2010
February 2012   (final data collection date for primary outcome measure)
  • Gait Velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improved ambulation status, specific to increase in gait velocity (m/s)
  • Stroke Impact Scale (SIS) Composite Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The SIS Composite score is equal to sum of scores for Mobility, ADL/IADL, and Social Participation domains. The questions for each domain are scored on a scale of 1-5, the higher the score the less the impact of Stroke on that domain question. The Mobility domain has 9 questions with scores ranging from 9 to 45. The ADL/IADL domain has 10 questions with scores ranging from 10-150- and the Social Participation domain has 8 question with a score of 8-40.
  • Device Related Serious Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The device related serious adverse event (SAE) measure is a count of the incidences of adverse events defined as serious (Incapacitating with inability to do work or usual activities; signs and symptoms may be systemic in nature or require medical evaluation and/or treatment; requiring additional hospitalization or intensive care (prolonged hospitalization) and device related (any AE for which a causal relationship between the event and the presence of the device, or the performance of the device system, is at least a reasonable possibility (i.e., the relationship cannot be excluded).
Improved Gait Speed, Improved Composite Stroke Impact Scale Scores, Rate of SAEs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improved ambulation status, specific to increase in gait velocity (m/s), measured via the 10 meter walk test by comparing the 6 month gait velocity of the WalkAide group to the AFO group.
  • Improved activities of daily living as measured by patient self-reported Stroke Impact Scale composite score for domains of activities of daily living/instrumental activities of daily living, mobility, and social participation
  • The primary safety endpoint is the rate of device related Serious Adverse Events through 6 month follow up
Complete list of historical versions of study NCT01087957 on ClinicalTrials.gov Archive Site
  • Six Minute Walk Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Modified Emory Functional Ambulation Profile Total Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) is composed of 5 subtasks: (1) 5 meter walk on a hard Floor, (2) 5 meter walk on a carpeted surface, (3) Timed Up & Go (rising from a chair, a 3-meter walk, and return to a seated position), (4) Navigating a Standardized Obstacle Course, and (5) ascending and descending 4 Stairs. Each is a timed task with the score consisting of the number of seconds required to complete the task. Upon completion of the entire data collection session, a total mEFAP score is calculated by adding the score on each subtask.
  • Modified Emory Functional Ambulation Profile Floor Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) Floor time sub-task is composed a timed 5 meter walk on a hard Floor. The score consists of the number of seconds required to complete the task. The Floor Time sub-task is added to the other 4 sub-tasks to make up the total mEFAP score.
  • Modified Emory Functional Ambulation Profile Carpet Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) Carpet time sub-task is composed of a 5 meter walk on a carpeted surface with the score consisting of the number of seconds required to complete the task. The score on the Carpet time sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score .
  • Modified Emory Functional Ambulation Profile Timed up and Go [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) Timed up and Go subtask is composed of rising from a chair, walking 3-meters, and returning to a seated position with the score consisting of the number of seconds required to complete the task. The Timed up and Go subtask is added to the other 4 sub-task scores to calculate the total mEFAP score.
  • Modified Emory Functional Ambulation Profile Obstacle Course [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) Obstacle course sub-task is composed navigating a Standardized Obstacle Course with the score consisting of the number of seconds required to complete the task. The obstacle course sub-task is added to the other 4 sub-tasks to calculate the total mEFAP score.
  • Modified Emory Functional Ambulation Profile Stair Time [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Modified Emory Functional Ambulation Profile (mEFAP) Stair time sub-task is composed of ascending and descending 4 Stairs with the score consisting of the number of seconds required to complete the task. The Stair time sub-task score is added to the other 4 subtask scores to calculate the total mEFAP score .
  • Berg Balance Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Berg Balance Assessment is a 14 item scale designed to measure balance in adults in a clinical setting. Each item is scored on a scale of 0-4 with a score of 0 indicating the most difficulty with the balance task. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.
Not Provided
Not Provided
Not Provided
 
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
Randomized Trial of the Innovative Neurotronics WalkAide Compared to Conventional Ankle-Foot Orthosis (AFO) in Stroke Patients (INSTRIDE)

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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
  • Device: WalkAide
    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: Ankle-Foot Orthosis (AFO)
    Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
    Intervention: Other: Ankle-Foot Orthosis (AFO)
  • Active Comparator: WalkAide
    Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
    Intervention: Device: WalkAide
Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M, Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt M, Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The Effects of Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in Patients With Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2014 Feb 13. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
June 2013
February 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087957
INSTRIDE
Yes
Innovative Neurotronics
Innovative Neurotronics
Not Provided
Principal Investigator: Francois Bethoux, M.D. The Cleveland Clinic
Innovative Neurotronics
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP