Efficacy of the WalkAide and AFOs for CVA

NCT00216320 | Completed Results

• 1 other identifier: WalkAide Trials
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 5

Brief Summary

To assess the effectiveness of a new stimulator (WalkAide) for the treatment of foot drop. The comparison will involve physical measurements (e.g. walking speed, physiological cost index, Modified Rivermead Mobility Index, etc.) and questionnaires on the quality of life and acceptance of the technology by stroke survivors.

Conditions

Stroke

Keywords

electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Figure 8 Walking Speed Before and After Intervention.

  Subjects walked a 10 meter Figure 8 pattern for four minutes at fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks

  baseline, 6, 6.2 and 12 weeks

• Physiological Cost Index Before and After Intervention.

  PCI is the difference between resting heart rate and active heart rate during walking, divided by average walking speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks

  baseline, 6, 6.2 and 12 weeks

• 10 Meter Walking Speed Before and After Intervention.

  Subjects walked 10 meters at their fastest safe speed. This was measured under two conditions: On condition - the WA turned on or the AFO worn by the subject; off condition - The WA turned off or the AFO not worn by the subject. The endpoints were analyzed at 6, and 12 weeks

  baseline, 6, 6.2 and 12 weeks

Secondary Outcomes (1)

• Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO

  12 weeks

Study Arms (3)

WalkAide

EXPERIMENTAL

Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks

Device: WalkAide; Device: AFO

Ankle Foot Orthosis

ACTIVE COMPARATOR

Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks

Device: WalkAide; Device: AFO

No Crossover

OTHER

Subjects wear AFO for entire 12 weeks with no crossover

Device: AFO

Interventions

WalkAide DEVICE

Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks

Ankle Foot Orthosis; WalkAide

AFO DEVICE

Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks

Ankle Foot Orthosis; WalkAide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosed with cerebrovascular accident (CVA) within the last 365 days
• Inadequate dorsiflexion during the swing phase of gait, resulting in inadequate limb clearance
• Medically stable for six months prior to the most recent episode of stroke resulting in hemiplegia or hemiparesis with foot drop
• Medical clearance by the attending physician to participate in the study
• Expectation that current medication can be maintained without drastic change for at least six months
• Adequate stability at the ankle during stance (with stimulation)
• Adequate cognitive and communication function to give informed consent, understand the training instructions, use the device and give adequate feedback
• Ability to ambulate with or without an assistive device (or assistance) at least 10 meters

You may not qualify if:

• Lower motor neuron injury with inadequate response to stimulation
• History of falls greater than once a week prior to the CVA
• Severe cardiac disease such as myocardial infarction, congestive heart failure or a demand pacemaker (or other electrical stimulator)
• Fixed ankle contractures of five degrees of plantarflexion with knee extended
• Moderate to normal ambulation velocity (greater than 1.2 m/s)
• Unable to operate the device safely by self and caregiver assistance not available
• Need for an AFO for stance control of the foot, ankle and/or knee
• Comorbid conditions unlikely to survive one year
• Pre-existing history of seizure disorder prior to most recent episode of CVA
• Pre-existing pathology resulting in a significant disruption in alignment or function of the lower extremity
• Morbid obesity that limits the subject's response to stimulation due to adipose tissue \[BMI \> 40\]
• Excessive dysesthetic pain secondary to neurological involvement
• Severe hypertonicity resulting in the need for more involved orthotic strategies or pharmacological interventions (e.g. Botox)

Sponsors & Collaborators

• Innovative Neurotronics: lead

Study Sites (5)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

University of Pittsburgh, Department of PM&R

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Institute of Rehabilitation Research

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Everaert DG, Stein RB, Abrams GM, Dromerick AW, Francisco GE, Hafner BJ, Huskey TN, Munin MC, Nolan KJ, Kufta CV. Effect of a foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: a multicenter randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):579-91. doi: 10.1177/1545968313481278. Epub 2013 Apr 4.

  PMID: 23558080 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Innovative Neurotronics

hrogers@ininc.us

512-721-1922

Study Officials

• Michael C Munin, MD

  University of Pittsburgh, Department of PM&R

  PRINCIPAL INVESTIGATOR

• Sunil Hegde, MD

  Huntington Rehabilitation Medicine Associates

  PRINCIPAL INVESTIGATOR

• Gerard Francisco, MD

  Texas Institute of Rehabilitation Research

  PRINCIPAL INVESTIGATOR

• Richard Herman, MD

  Good Samaritan Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

• Thy Huskey, MD

  Washington University in St. Louis, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Gary Abrams, MD

  University of California; San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 19, 2013
• Results First Posted: April 19, 2013

Record last verified: 2013-04

Locations

US (5)