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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
--/--
--/--
--/--
Serious Adverse Events 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
Other (Not Including Serious) Adverse Events 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
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