Trial Outcomes & Findings for Efficacy of the WalkAide and AFOs for CVA (NCT NCT00216320)
NCT ID: NCT00216320
Last Updated: 2013-04-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
baseline, 6, 6.2 and 12 weeks
Results posted on
2013-04-19
Participant Flow
Recruitment took place between May 2005 and December 2008 at 9 Rehabilitation centers in the USA.
Participant milestones
| Measure |
Arm 1: WalkAide
Subjects started with the WalkAide and crossed over to the AFO after six weeks.
|
Arm 2: Ankle Foot Orthosis
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
|---|---|---|---|
|
Phase 1 (Weeks 0 - 6)
STARTED
|
43
|
39
|
30
|
|
Phase 1 (Weeks 0 - 6)
COMPLETED
|
43
|
35
|
25
|
|
Phase 1 (Weeks 0 - 6)
NOT COMPLETED
|
0
|
4
|
5
|
|
Phase 2 (Weeks 6 -12)
STARTED
|
43
|
35
|
25
|
|
Phase 2 (Weeks 6 -12)
COMPLETED
|
38
|
31
|
24
|
|
Phase 2 (Weeks 6 -12)
NOT COMPLETED
|
5
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of the WalkAide and AFOs for CVA
Baseline characteristics by cohort
| Measure |
Arm 1: WalkAide
n=43 Participants
Subjects started with the WalkAide and crossed over to the AFO after six weeks.
|
Arm 2: Ankle Foot Orthosis
n=39 Participants
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
n=30 Participants
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
57.1 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Chronicity
|
6.4 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
6.9 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
5.8 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
6.4 years
STANDARD_DEVIATION 3.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, 6, 6.2 and 12 weeksSubjects 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
Outcome measures
| Measure |
Subjects Who Used Both WA and AFO
n=38 Participants
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
|
Arm 2: Ankle Foot Orthosis
n=31 Participants
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
n=24 Participants
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
|---|---|---|---|
|
Figure 8 Walking Speed Before and After Intervention.
Week 0 off condition
|
.337 meters/second
Standard Deviation .164
|
.312 meters/second
Standard Deviation .151
|
.261 meters/second
Standard Deviation .182
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 6 off condition
|
.432 meters/second
Standard Deviation .207
|
.377 meters/second
Standard Deviation .166
|
.303 meters/second
Standard Deviation .195
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 0 on condition
|
.358 meters/second
Standard Deviation .157
|
.368 meters/second
Standard Deviation .186
|
.331 meters/second
Standard Deviation .203
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 6 on condition
|
.456 meters/second
Standard Deviation .205
|
.428 meters/second
Standard Deviation .179
|
.366 meters/second
Standard Deviation .205
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 6.2 off condition
|
.446 meters/second
Standard Deviation .216
|
.383 meters/second
Standard Deviation .162
|
.303 meters/second
Standard Deviation .195
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 12 off condition
|
.467 meters/second
Standard Deviation .233
|
.420 meters/second
Standard Deviation .171
|
.328 meters/second
Standard Deviation .212
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 6.2 on condition
|
.471 meters/second
Standard Deviation .219
|
.400 meters/second
Standard Deviation .153
|
.366 meters/second
Standard Deviation .205
|
|
Figure 8 Walking Speed Before and After Intervention.
Week 12 on condition
|
.520 meters/second
Standard Deviation .236
|
.436 meters/second
Standard Deviation .172
|
.388 meters/second
Standard Deviation .208
|
PRIMARY outcome
Timeframe: baseline, 6, 6.2 and 12 weeksPCI 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
Outcome measures
| Measure |
Subjects Who Used Both WA and AFO
n=33 Participants
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
|
Arm 2: Ankle Foot Orthosis
n=27 Participants
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
n=17 Participants
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
|---|---|---|---|
|
Physiological Cost Index Before and After Intervention.
Week 0 off condition
|
.957 beats/minute
Standard Deviation 0618
|
1.128 beats/minute
Standard Deviation .616
|
1.486 beats/minute
Standard Deviation .753
|
|
Physiological Cost Index Before and After Intervention.
Week 6 off condition
|
.824 beats/minute
Standard Deviation .446
|
.978 beats/minute
Standard Deviation .698
|
1.311 beats/minute
Standard Deviation .720
|
|
Physiological Cost Index Before and After Intervention.
Week 0 on condition
|
.985 beats/minute
Standard Deviation .580
|
.903 beats/minute
Standard Deviation .440
|
1.163 beats/minute
Standard Deviation .621
|
|
Physiological Cost Index Before and After Intervention.
Week 6 on condition
|
.791 beats/minute
Standard Deviation .411
|
.853 beats/minute
Standard Deviation .471
|
1.022 beats/minute
Standard Deviation .455
|
|
Physiological Cost Index Before and After Intervention.
Week 6.2 off condition
|
.796 beats/minute
Standard Deviation .484
|
.908 beats/minute
Standard Deviation .499
|
1.311 beats/minute
Standard Deviation .720
|
|
Physiological Cost Index Before and After Intervention.
Week 12 off condition
|
.712 beats/minute
Standard Deviation .494
|
.983 beats/minute
Standard Deviation .662
|
1.160 beats/minute
Standard Deviation .823
|
|
Physiological Cost Index Before and After Intervention.
Week 6.2 on condition
|
.726 beats/minute
Standard Deviation .435
|
.847 beats/minute
Standard Deviation .400
|
1.022 beats/minute
Standard Deviation .455
|
|
Physiological Cost Index Before and After Intervention.
Week 12 on condition
|
.656 beats/minute
Standard Deviation .325
|
.972 beats/minute
Standard Deviation .694
|
.892 beats/minute
Standard Deviation .481
|
PRIMARY outcome
Timeframe: baseline, 6, 6.2 and 12 weeksSubjects 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
Outcome measures
| Measure |
Subjects Who Used Both WA and AFO
n=38 Participants
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
|
Arm 2: Ankle Foot Orthosis
n=31 Participants
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
n=24 Participants
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
|---|---|---|---|
|
10 Meter Walking Speed Before and After Intervention.
Week 6.2 off condition
|
.591 meters/second
Standard Deviation .304
|
.486 meters/second
Standard Deviation .229
|
.428 meters/second
Standard Deviation .286
|
|
10 Meter Walking Speed Before and After Intervention.
Week 12 off condition
|
.641 meters/second
Standard Deviation .349
|
.564 meters/second
Standard Deviation .264
|
.477 meters/second
Standard Deviation .296
|
|
10 Meter Walking Speed Before and After Intervention.
Week 0 off condition
|
.457 meters/second
Standard Deviation .245
|
.415 meters/second
Standard Deviation .220
|
.361 meters/second
Standard Deviation .264
|
|
10 Meter Walking Speed Before and After Intervention.
Week 6 off condition
|
.575 meters/second
Standard Deviation .291
|
.489 meters/second
Standard Deviation .233
|
.428 meters/second
Standard Deviation .286
|
|
10 Meter Walking Speed Before and After Intervention.
Week 0 on condition
|
.524 meters/second
Standard Deviation .253
|
.472 meters/second
Standard Deviation .246
|
.438 meters/second
Standard Deviation .286
|
|
10 Meter Walking Speed Before and After Intervention.
Week 6 on condition
|
.625 meters/second
Standard Deviation .309
|
.568 meters/second
Standard Deviation .261
|
.500 meters/second
Standard Deviation .308
|
|
10 Meter Walking Speed Before and After Intervention.
Week 6.2 on condition
|
.645 meters/second
Standard Deviation .313
|
.508 meters/second
Standard Deviation .223
|
.500 meters/second
Standard Deviation .308
|
|
10 Meter Walking Speed Before and After Intervention.
Week 12 on condition
|
.730 meters/second
Standard Deviation .369
|
.596 meters/second
Standard Deviation .278
|
.546 meters/second
Standard Deviation .326
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: per protocol (completers) analysis
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
Outcome measures
| Measure |
Subjects Who Used Both WA and AFO
n=64 Participants
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
|
Arm 2: Ankle Foot Orthosis
Subjects started with the AFO and crossed over to the WalkAide after six weeks.
|
Arm 3: No Crossover
Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
|
|---|---|---|---|
|
Number of Subjects Who Preferred Use of WalkAide Over the Use of AFO
|
45 participants
|
—
|
—
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=43 participants at risk
All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
|
Arm 2
n=39 participants at risk
All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
|
Arm 3
n=30 participants at risk
All subjects used AFO for all 12 weeks of study.
|
|---|---|---|---|
|
Cardiac disorders
Heart surgery
|
0.00%
0/43 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Death
|
2.3%
1/43 • Number of events 1 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Wrist Fracture
|
0.00%
0/43 • 12 weeks
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
Other adverse events
| Measure |
Arm 1
n=43 participants at risk
All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
|
Arm 2
n=39 participants at risk
All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
|
Arm 3
n=30 participants at risk
All subjects used AFO for all 12 weeks of study.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation electrodes
|
9.3%
4/43 • Number of events 7 • 12 weeks
|
7.7%
3/39 • Number of events 4 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation AFO
|
4.7%
2/43 • Number of events 2 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
2/43 • Number of events 2 • 12 weeks
|
5.1%
2/39 • Number of events 2 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Ankle sprain
|
2.3%
1/43 • Number of events 1 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus condition
|
0.00%
0/43 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
|
General disorders
Lost consciousness
|
2.3%
1/43 • Number of events 1 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
General disorders
weakness and fatigue
|
0.00%
0/43 • 12 weeks
|
2.6%
1/39 • Number of events 1 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
LE swelling
|
2.3%
1/43 • Number of events 1 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Shoulder surgery
|
0.00%
0/43 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
3.3%
1/30 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place