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Efficacy of the WalkAide and AFOs for CVA

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ClinicalTrials.gov Identifier: NCT00216320
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Innovative Neurotronics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: WalkAide
Device: AFO
Enrollment 121
Recruitment Details Recruitment took place between May 2005 and December 2008 at 9 Rehabilitation centers in the USA.
Pre-assignment Details  
Arm/Group Title Arm 1: WalkAide Arm 2: Ankle Foot Orthosis Arm 3: No Crossover
Hide Arm/Group Description Subjects started with the WalkAide and crossed over to the AFO after six weeks. Subjects started with the AFO and crossed over to the WalkAide after six weeks. Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Period Title: Phase 1 (Weeks 0 - 6)
Started 43 39 30
Completed 43 35 25
Not Completed 0 4 5
Period Title: Phase 2 (Weeks 6 -12)
Started 43 35 25
Completed 38 31 24
Not Completed 5 4 1
Arm/Group Title Arm 1: WalkAide Arm 2: Ankle Foot Orthosis Arm 3: No Crossover Total
Hide Arm/Group Description Subjects started with the WalkAide and crossed over to the AFO after six weeks. Subjects started with the AFO and crossed over to the WalkAide after six weeks. Subjects completed the entire 12 weeks period with the AFO, no crossover occurred. Total of all reporting groups
Overall Number of Baseline Participants 43 39 30 112
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 39 participants 30 participants 112 participants
57.1  (12.9) 55.6  (11.9) 58.8  (9.8) 57.0  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 39 participants 30 participants 112 participants
Female
7
  16.3%
16
  41.0%
12
  40.0%
35
  31.3%
Male
36
  83.7%
23
  59.0%
18
  60.0%
77
  68.8%
Chronicity   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 39 participants 30 participants 112 participants
6.4  (3.8) 6.9  (3.2) 5.8  (3.7) 6.4  (3.6)
[1]
Measure Description: Chronicity refers to the number of years since onset of stroke
1.Primary Outcome
Title Figure 8 Walking Speed Before and After Intervention.
Hide Description 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
Time Frame baseline, 6, 6.2 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: WalkAide Arm 2: Ankle Foot Orthosis Arm 3: No Crossover
Hide Arm/Group Description:
Subjects started with the WalkAide and crossed over to the AFO after six weeks.
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed 38 31 24
Mean (Standard Deviation)
Unit of Measure: meters/second
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)
2.Primary Outcome
Title Physiological Cost Index Before and After Intervention.
Hide Description 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
Time Frame baseline, 6, 6.2 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: WalkAide Arm 2: Ankle Foot Orthosis Arm 3: No Crossover
Hide Arm/Group Description:
Subjects started with the WalkAide and crossed over to the AFO after six weeks.
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed 33 27 17
Mean (Standard Deviation)
Unit of Measure: beats/minute
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)
3.Primary Outcome
Title 10 Meter Walking Speed Before and After Intervention.
Hide Description 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
Time Frame baseline, 6, 6.2 and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: WalkAide Arm 2: Ankle Foot Orthosis Arm 3: No Crossover
Hide Arm/Group Description:
Subjects started with the WalkAide and crossed over to the AFO after six weeks.
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
Overall Number of Participants Analyzed 38 31 24
Mean (Standard Deviation)
Unit of Measure: meters/second
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)
4.Secondary Outcome
Title Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
Hide Description 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
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol (completers) analysis
Arm/Group Title Subjects Who Used Both WA and AFO
Hide Arm/Group Description:
Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
45
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subjects Who Used Both WA and AFO
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks. All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks. All subjects used AFO for all 12 weeks of study.
All-Cause Mortality
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/43 (2.33%)      1/39 (2.56%)      1/30 (3.33%)    
Cardiac disorders       
Heart surgery  [1]  0/43 (0.00%)  0 0/39 (0.00%)  0 1/30 (3.33%)  1
Death  [2]  1/43 (2.33%)  1 0/39 (0.00%)  0 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Wrist Fracture  [3]  0/43 (0.00%)  0 1/39 (2.56%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Had emergency heart surgery 9/15/06
[2]
began experiencing symptoms, went to ER and was admitted for an acute MI. Patient was discharged from the hospital and scheduled for heart surgery to remove blockage. However he then passed away suddenly, before the surgery was done
[3]
Pt fell and fractured wrist. Subject was in teh AFO phase of Arm @ but was not wearing a study device at the time
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2 Arm 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/43 (16.28%)      5/39 (12.82%)      1/30 (3.33%)    
General disorders       
Lost consciousness  [1]  1/43 (2.33%)  1 0/39 (0.00%)  0 0/30 (0.00%)  0
weakness and fatigue  [2]  0/43 (0.00%)  0 1/39 (2.56%)  1 0/30 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  [3]  2/43 (4.65%)  2 2/39 (5.13%)  2 1/30 (3.33%)  1
Ankle sprain  [4]  1/43 (2.33%)  1 0/39 (0.00%)  0 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders       
LE swelling  [5]  1/43 (2.33%)  1 0/39 (0.00%)  0 0/30 (0.00%)  0
Shoulder surgery  [6]  0/43 (0.00%)  0 0/39 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders       
Sinus condition  [7]  0/43 (0.00%)  0 0/39 (0.00%)  0 1/30 (3.33%)  1
Skin and subcutaneous tissue disorders       
Skin Irritation electrodes  [8]  4/43 (9.30%)  7 3/39 (7.69%)  4 0/30 (0.00%)  0
Skin irritation AFO   2/43 (4.65%)  2 0/39 (0.00%)  0 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Pt lost consciousness in Physical Therapy, no reason was reported
[2]
Subject was weak and fatigued, required bedrest
[3]
tripped and fell
[4]
sprained ankle getting out of bed
[5]
Subject complained of swelling not previously noted
[6]
Subject had surgery for rotator cuff tear
[7]
subject missed visit due to sinus infection
[8]
Irritation from electrodes used with WalkAide
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Research
Organization: Innovative Neurotronics
Phone: 512-721-1922
Responsible Party: Innovative Neurotronics
ClinicalTrials.gov Identifier: NCT00216320     History of Changes
Other Study ID Numbers: WalkAide Trials
First Submitted: September 19, 2005
First Posted: September 22, 2005
Results First Submitted: April 18, 2013
Results First Posted: April 19, 2013
Last Update Posted: April 19, 2013