Trial Outcomes & Findings for Walking Aids in the Management of Knee Osteoarthritis (NCT NCT00223795)
NCT ID: NCT00223795
Last Updated: 2017-11-01
Results Overview
An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).
COMPLETED
NA
53 participants
Baseline and end of first intervention period (2 months)
2017-11-01
Participant Flow
Subjects were recruited 2005-2008from the outpatient clinics of the VA West Los Angeles Healthcare Center, an urban tertiary academic hospital.
Participant milestones
| Measure |
Arm 1 - Control/Crossover
No cane first, then single point cane
|
Arm 2 - Cane
Single point cane first, then continue with single point cane
|
|---|---|---|
|
First Intervention - Eight Weeks
STARTED
|
26
|
27
|
|
First Intervention - Eight Weeks
COMPLETED
|
19
|
18
|
|
First Intervention - Eight Weeks
NOT COMPLETED
|
7
|
9
|
|
Second Intervention - All Use Canes 4 mo
STARTED
|
19
|
18
|
|
Second Intervention - All Use Canes 4 mo
COMPLETED
|
18
|
17
|
|
Second Intervention - All Use Canes 4 mo
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 - Control/Crossover
No cane first, then single point cane
|
Arm 2 - Cane
Single point cane first, then continue with single point cane
|
|---|---|---|
|
First Intervention - Eight Weeks
Lost to Follow-up
|
7
|
9
|
|
Second Intervention - All Use Canes 4 mo
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Walking Aids in the Management of Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Baseline Characteristics All Subjects
n=53 Participants
Community-dwelling patients with unilateral knee pain on movement which they scored at \>35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade \> 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of first intervention period (2 months)An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months).
Outcome measures
| Measure |
Arm 1 - Waiting Control
n=26 Participants
Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
|
Arm 2- Cane Users
n=27 Participants
Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
|
|---|---|---|
|
Peak Vertical Force on Affected Limb
Baseline - no cane
|
9.5 N/kg
Standard Deviation 1.2
|
8.5 N/kg
Standard Deviation 1.8
|
|
Peak Vertical Force on Affected Limb
Baseline - with cane
|
8.8 N/kg
Standard Deviation 1.8
|
7.5 N/kg
Standard Deviation 1.8
|
|
Peak Vertical Force on Affected Limb
2 months - no cane
|
9.1 N/kg
Standard Deviation 1.1
|
8.9 N/kg
Standard Deviation 1.2
|
|
Peak Vertical Force on Affected Limb
2 months - with cane
|
8.3 N/kg
Standard Deviation 1.0
|
8.0 N/kg
Standard Deviation 1.2
|
Adverse Events
Arm 1: Intervention - no Cane for First 8 Weeks
Arm 1 - Intervention - Crossover to Cane
Arm 2- Single Point Cane
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Meika A. Fang, MD
VA Greater Los Angeles Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place