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

Completed

Phase N/A Results

Update History

15 May '14
The eligibility criteria were updated.
New
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.
Old
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.
8 May '12
A location was updated in Loma Linda.
New
The overall status was removed for The Loma Linda University Medical Center.
A location was updated in Los Angeles.
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The overall status was removed for The Los Angeles VA.
A location was updated in Pomona.
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The overall status was removed for Casa Colina Centers for Rehabilitation.
A location was updated in San Francisco.
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The overall status was removed for The San Francisco VA Medical Center.
A location was updated in Hartford.
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The overall status was removed for Hartford Hospital.
A location was updated in Daytona Beach.
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The overall status was removed for Halifax Hospital.
A location was updated in Orlando.
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The overall status was removed for Florida Hospital NORI.
A location was updated in Chicago.
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The overall status was removed for University of Illinois at Chicago.
A location was updated in Chicago.
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The overall status was removed for Rehabilitation Institute of Chicago.
A location was updated in Wheaton.
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The overall status was removed for Marianjoy Rehabilitation.
A location was updated in Lexington.
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The overall status was removed for Cardinal Hill Rehabilitation.
A location was updated in Saginaw.
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The overall status was removed for St. Mary's of Michigan.
A location was updated in Minneapolis.
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The overall status was removed for University of Minnesota Twin-Cities.
A location was updated in Lincoln.
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The overall status was removed for Madonna Rehabilitation Hospital.
A location was updated in West Orange.
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The overall status was removed for Kessler Foundation Research Center.
A location was updated in Johnson City.
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The overall status was removed for United Healthcare.
A location was updated in Patchogue.
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The overall status was removed for South Shore Neurologic Associates.
A location was updated in Syracuse.
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The overall status was removed for SUNY Upstate Medical University.
A location was updated in West Haverstraw.
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The overall status was removed for Health Research Inc./Helen Hayes Hospital.
A location was updated in Greensboro.
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The overall status was removed for Guilford Neurologic Associates.
A location was updated in Pinehurst.
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The overall status was removed for FirstHealth of the Carolinas.
A location was updated in Cleveland.
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The overall status was removed for The Cleveland Clinic.
A location was updated in Columbus.
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The overall status was removed for The Ohio State University Medical Center.
A location was updated in Portland.
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The overall status was removed for Oregon Health & Science University.
A location was updated in Philadelphia.
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The overall status was removed for Magee Rehabilitation Hospital.
A location was updated in Charleston.
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The overall status was removed for Medical University of South Carolina.
A location was updated in Austin.
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The overall status was removed for St. David's Rehabilitation Hospital.
A location was updated in Dallas.
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The overall status was removed for The Dallas VA.
A location was updated in Marshfield.
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The overall status was removed for Marshfield Clinic Research Foundation.
24 Mar '12
The Summary of Purpose was updated.
New
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.
Old
The purpose of this clinical trial is to establish equivalence or incremental benefit of the Walkaide device to standard of care Ankle Foot Orthosis (AFO) for patients with foot drop due to stroke.
The description was updated.
New
This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).
Old
This is an un-blinded, randomized, parallel group, controlled trial with a group-sequential design and a single interim analysis. The purpose of this study is to compare the performance of the WalkAide device with Functional Electrical Stimulation (FES) versus Ankle-Foot Orthosis (AFO) in patients with sub-acute and chronic stroke.
The eligibility criteria were updated.
New
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.
Old
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 has had no prior therapy using the WalkAide system. - 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. - 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, defined as -5° plantar flexion34. - 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 60 years of age or older or eligible for Medicare benefits at time of consent. - 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 has an initial gait speed of 0.8m/s or greater classified as a full community walker (independent in all home and community activities). - 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. - Need for an AFO for stance control of the foot, ankle and/or knee. - Patient has peripheral neuropathy that would obstruct or limit ambulation or participation in study procedures. - The patient has 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 dysesthetic pain secondary to neurological involvement. - Patient is less than 30 days post stroke rehabilitation at time of enrollment. - Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).33 - 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. - Patient has aphasia, defined as incapacity to follow two-step 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 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.
19 Nov '11
The eligibility criteria were updated.
New
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 has had no prior therapy using the WalkAide system. - 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. - 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, defined as -5° plantar flexion34. - 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 60 years of age or older or eligible for Medicare benefits at time of consent. - 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 has an initial gait speed of 0.8m/s or greater classified as a full community walker (independent in all home and community activities). - 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. - Need for an AFO for stance control of the foot, ankle and/or knee. - Patient has peripheral neuropathy that would obstruct or limit ambulation or participation in study procedures. - The patient has 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 dysesthetic pain secondary to neurological involvement. - Patient is less than 30 days post stroke rehabilitation at time of enrollment. - Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).33 - 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. - Patient has aphasia, defined as incapacity to follow two-step 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 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.
Old
Inclusion Criteria: - Patient history of stroke (ischemic and/or hemorrhagic). - Patient is at least 90 days post stroke. - Patient has hemiplegia/hemiparesis. - Patient has inadequate dorsiflexion during swing phase of gait, resulting in inadequate limb clearance. - Patient has had no prior therapy using the WalkAide system. - Patient has not participated in or is a minimum of 30 days post inpatient or outpatient stroke, cardiac, pulmonary, or physical rehabilitation. - 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. - 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, defined as -5° plantar flexion34. - 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 60 years of age or older or eligible for Medicare benefits at time of consent. - 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 has an initial gait speed of 0.8m/s or greater classified as a full community walker (independent in all home and community activities). - 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. - Need for an AFO for stance control of the foot, ankle and/or knee. - In the Investigator's opinion, patient has peripheral neuropathy that would obstruct or limit ambulation or participation in study procedures. - In the Investigator's opinion, the patient has significant peripheral vascular disease accompanied by lower extremity ulceration and/or disabling claudication. - In the Investigator's opinion, the patient has underlying condition(s) that would limit study participation. - Severe hypertonicity resulting in the need for more involved orthotic strategies. - Excessive dysesthetic pain secondary to neurological involvement. - Patient is less than 30 days post stroke rehabilitation at time of enrollment. - Patient has moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD).33 - 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. - Patient has aphasia, defined as incapacity to follow two-step 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 Botox injection in the upper and/or lower extremity.32 - 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.