StrokeNCT00216320

Efficacy of the WalkAide and AFOs for CVA

A study testing WalkAide and AFO in people with Stroke, run by Innovative Neurotronics at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: WalkAide and AFO
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 5 sitesUnited States
Study dates: Sep 2005to Nov 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 13Show fewer

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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Texas Institute of Rehabilitation Research
Houston, Texas, 77030
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
University of Pittsburgh, Department of PM&R
Pittsburgh, Pennsylvania, 15213
San Francisco VA Medical Center
San Francisco, California, 94121
Washington University
St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]

Read the detailed description

Stroke is the third leading cause of death in the United States and other developed countries and a major source of disability, often leading to hospitalization. Prognosis for regaining the ability to walk is good, with 64% of those initially dependent in walking regaining independence by three months. However, many gait abnormalities persist.

Reduced hip, knee and ankle excursions during swing are among the persistent gait abnormalities contributing to poor or inefficient limb clearance. This is generally referred to as "foot drop", since the foot drops or drags along the ground during the swing phase. Swing phase abnormalities can result in decreased velocity, limited endurance and an increased risk for falls. These factors can limit mobility and independence in the community. Therefore, intervention is warranted.

The conventional approach to address the poor swing limb function, specifically, insufficient ankle dorsiflexion, is the prescription of an ankle-foot orthosis (AFO). An AFO commonly limits ankle plantarflexion to enhance limb clearance during swing. An alternative approach is to stimulate the ankle dorsiflexors electrically during swing phase to reproduce motion, which can no longer be performed volitionally.

The WalkAide is a new foot drop stimulator. This small, self-contained device attaches to the leg below the knee. The WalkAide contains a number of patented features, including a tilt sensor that measures the orientation of the leg with respect to the vertical. When the leg is tilted back at the end of stance, stimulation of the common peroneal nerve is initiated. This produces flexion of the ankle and other joints (if a flexion reflex is elicited) so that the leg can clear the ground during swing. When the leg is tilted forward at the end of swing phase, the stimulus is terminated. The electrodes attach to the inside of a cuff that is molded to the leg for reproducible positioning from day to day. The device is also designed so that all operations can be done with a single hand, since hemiparesis may prevent the subject from using the other hand. Because of its enhanced features, the WalkAide is anticipated to increase walking speed and improve the quality of life.

Conditions: Stroke
Being tested: WalkAide, AFO
Keywords: electrical stimulation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WalkAideDevice
Arm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
AFODevice
Arm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
AFODevice
Arm 3 - Subjects wear AFO for entire 12 weeks with no crossover

Study groups in NCT00216320
Study group	Role	What they receive
WalkAide	Experimental	Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks Receives: Device: WalkAide; Device: AFO
Ankle Foot Orthosis	Active comparator	Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks Receives: Device: WalkAide; Device: AFO
No Crossover	Other	Subjects wear AFO for entire 12 weeks with no crossover Receives: Device: AFO

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: baseline, 6, 6.2 and 12 weeks

Secondary outcomes (1)

Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
Subjects in Arm 1 or 2 (who used both devices) were given the option to continue using WalkAide or AFO for additional 12 weeks, their preference was recorded along with reasons for preference
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Nov 2008

First posted22 Sep 2005 (estimated)
Study startSep 2005
Primary completionNov 2008
Study completionNov 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00216320
Sponsor's protocol ID: WalkAide Trials
Status last verified: Apr 2013
First submitted: 19 Sep 2005
Last updated: 19 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 23558080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Three-Arm, Randomized Crossover Study Comparing the Innovative Neurotronics WalkAide™ System to Ankle-Foot Orthosis [AFO]
ClinicalTrials.gov ID: NCT00216320
Acronym / sponsor ID: WalkAide Trials
Conditions: Stroke
Keywords: electrical stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Innovative NeurotronicsIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 19 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
WalkAide	Experimental	Device: WalkAide, Device: AFOSubjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks
Ankle Foot Orthosis	Active comparator	Device: WalkAide, Device: AFOSubjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks
No Crossover	Other	Device: AFOSubjects wear AFO for entire 12 weeks with no crossover

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WalkAideArm 1 - Subjects wear WalkAide for 6 weeks then cross over to AFO wear for 6 weeks	Device	Ankle Foot Orthosis, WalkAide
AFOArm 2 - Subjects wear AFO for 6 weeks then cross over to WalkAide wear for 6 weeks	Device	Ankle Foot Orthosis, WalkAide
AFOArm 3 - Subjects wear AFO for entire 12 weeks with no crossover	Device	No Crossover

Primary outcome

Figure 8 Walking Speed Before and After Intervention.
Time frame: baseline, 6, 6.2 and 12 weeks
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
Physiological Cost Index Before and After Intervention.
Time frame: baseline, 6, 6.2 and 12 weeks
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
10 Meter Walking Speed Before and After Intervention.
Time frame: baseline, 6, 6.2 and 12 weeks
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

1 secondary outcome

Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
Time frame: 12 weeks

Results and safety

Results posted to the registry on 19 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: WalkAide	43	43
Arm 2: Ankle Foot Orthosis	39	35
Arm 3: No Crossover	30	25

Primary outcome: Figure 8 Walking Speed Before and After Intervention.

Time frame: baseline, 6, 6.2 and 12 weeks. Mean (Standard Deviation). Unit: meters/second

Measure	Arm 1: WalkAide n = 38	Arm 2: Ankle Foot Orthosis n = 31	Arm 3: No Crossover n = 24
Week 0 off condition	.337 (.164)	.312 (.151)	.261 (.182)
Week 6 off condition	.432 (.207)	.377 (.166)	.303 (.195)
Week 0 on condition	.358 (.157)	.368 (.186)	.331 (.203)
Week 6 on condition	.456 (.205)	.428 (.179)	.366 (.205)
Week 6.2 off condition	.446 (.216)	.383 (.162)	.303 (.195)
Week 12 off condition	.467 (.233)	.420 (.171)	.328 (.212)
Week 6.2 on condition	.471 (.219)	.400 (.153)	.366 (.205)
Week 12 on condition	.520 (.236)	.436 (.172)	.388 (.208)

Primary outcome: Physiological Cost Index Before and After Intervention.

Time frame: baseline, 6, 6.2 and 12 weeks. Mean (Standard Deviation). Unit: beats/minute

Measure	Arm 1: WalkAide n = 33	Arm 2: Ankle Foot Orthosis n = 27	Arm 3: No Crossover n = 17
Week 0 off condition	.957 (0618)	1.128 (.616)	1.486 (.753)
Week 6 off condition	.824 (.446)	.978 (.698)	1.311 (.720)
Week 0 on condition	.985 (.580)	.903 (.440)	1.163 (.621)
Week 6 on condition	.791 (.411)	.853 (.471)	1.022 (.455)
Week 6.2 off condition	.796 (.484)	.908 (.499)	1.311 (.720)
Week 12 off condition	.712 (.494)	.983 (.662)	1.160 (.823)
Week 6.2 on condition	.726 (.435)	.847 (.400)	1.022 (.455)
Week 12 on condition	.656 (.325)	.972 (.694)	.892 (.481)

Primary outcome: 10 Meter Walking Speed Before and After Intervention.

Time frame: baseline, 6, 6.2 and 12 weeks. Mean (Standard Deviation). Unit: meters/second

Measure	Arm 1: WalkAide n = 38	Arm 2: Ankle Foot Orthosis n = 31	Arm 3: No Crossover n = 24
Week 0 off condition	.457 (.245)	.415 (.220)	.361 (.264)
Week 6 off condition	.575 (.291)	.489 (.233)	.428 (.286)
Week 0 on condition	.524 (.253)	.472 (.246)	.438 (.286)
Week 6 on condition	.625 (.309)	.568 (.261)	.500 (.308)
Week 6.2 off condition	.591 (.304)	.486 (.229)	.428 (.286)
Week 12 off condition	.641 (.349)	.564 (.264)	.477 (.296)
Week 6.2 on condition	.645 (.313)	.508 (.223)	.500 (.308)
Week 12 on condition	.730 (.369)	.596 (.278)	.546 (.326)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	1 of 43 (2.3%)	7 of 43 (16.3%)	Not reported
Arm 2	1 of 39 (2.6%)	5 of 39 (12.8%)	Not reported
Arm 3	1 of 30 (3.3%)	1 of 30 (3.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23558080Everaert 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.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael C Munin, MD principal investigator

University of Pittsburgh, Department of PM&R

Sunil Hegde, MD principal investigator

Huntington Rehabilitation Medicine Associates

Gerard Francisco, MD principal investigator

Texas Institute of Rehabilitation Research

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing WalkAide and AFO in people with Stroke, run by Innovative Neurotronics at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Figure 8 Walking Speed Before and After Intervention. (time frame: baseline, 6, 6.2 and 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00216320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013.