Trial Outcomes & Findings for Using Pressure Detecting Insoles to Reduce Knee Loading (NCT NCT02955225)
NCT ID: NCT02955225
Last Updated: 2023-03-03
Results Overview
Surrogate marker of medial knee loading, measured using 3D motion analysis, with initial SI units in Newton\*meters, and normalized to the individual's body weight and height, resulting in measurement units (% bodyweight \* height). To assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify the joint moments in three directions. This study focused on the change in joint moment in the frontal plane. After training with an active insole, we would expect reductions in the frontal plane knee joint moment. Generally speaking, lower moments are better and a negative change is desired.
COMPLETED
NA
38 participants
Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training
2023-03-03
Participant Flow
Participant milestones
| Measure |
Flexible Shoe With Active Insole
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
12
|
|
Overall Study
COMPLETED
|
21
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=26 Participants
|
63 years
STANDARD_DEVIATION 8 • n=12 Participants
|
63 years
STANDARD_DEVIATION 9 • n=38 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=26 Participants
|
8 Participants
n=12 Participants
|
30 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=26 Participants
|
4 Participants
n=12 Participants
|
8 Participants
n=38 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 Participants
n=26 Participants
|
12 Participants
n=12 Participants
|
38 Participants
n=38 Participants
|
|
Knee Adduction Moment (KAM1)
|
3.21 %bodyweight x height
STANDARD_DEVIATION 0.99 • n=26 Participants
|
3.27 %bodyweight x height
STANDARD_DEVIATION 0.97 • n=12 Participants
|
3.27 %bodyweight x height
STANDARD_DEVIATION 0.91 • n=38 Participants
|
PRIMARY outcome
Timeframe: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing trainingSurrogate marker of medial knee loading, measured using 3D motion analysis, with initial SI units in Newton\*meters, and normalized to the individual's body weight and height, resulting in measurement units (% bodyweight \* height). To assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify the joint moments in three directions. This study focused on the change in joint moment in the frontal plane. After training with an active insole, we would expect reductions in the frontal plane knee joint moment. Generally speaking, lower moments are better and a negative change is desired.
Outcome measures
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Change in Knee Adduction Moment Relative to Baseline
Immediate
|
-0.21 percentage of bodyweight x height
Interval -0.31 to -0.11
|
-0.09 percentage of bodyweight x height
Interval -0.24 to 0.07
|
|
Change in Knee Adduction Moment Relative to Baseline
3 weeks
|
-0.21 percentage of bodyweight x height
Interval -0.33 to -0.09
|
-0.24 percentage of bodyweight x height
Interval -0.41 to -0.06
|
|
Change in Knee Adduction Moment Relative to Baseline
6 weeks (washout)
|
-0.12 percentage of bodyweight x height
Interval -0.24 to 0.01
|
-0.12 percentage of bodyweight x height
Interval -0.35 to 0.01
|
SECONDARY outcome
Timeframe: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing trainingTo further assess changes in loading at the knee between baseline and the three post-baseline measurements (Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing training), participants underwent gait analysis in a motion analysis laboratory using force plates and optoelectric cameras to quantify joint moment. One component which determines the knee moment is the lever-arm between ground reaction force vector and the center of the knee joint, in the frontal plane, which is measured in millimeters.
Outcome measures
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Change in Moment Lever-arm for KAM
Immediate
|
-6 mm (millimeters)
Interval -9.0 to -4.0
|
1 mm (millimeters)
Interval -3.0 to 4.0
|
|
Change in Moment Lever-arm for KAM
3 weeks
|
-5 mm (millimeters)
Interval -7.0 to -2.0
|
3 mm (millimeters)
Interval -1.0 to 6.0
|
|
Change in Moment Lever-arm for KAM
6 weeks (washout)
|
-2 mm (millimeters)
Interval -4.0 to 1.0
|
3 mm (millimeters)
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: Immediately after initial training, after 3 weeks of ongoing training, after 6 weeks of ongoing trainingA change in Speed (m/s) after 3 and 6 weeks of training with insoles.
Outcome measures
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Change in SPEED
Immediate
|
-.09 Meters/sec
Interval -0.12 to -0.05
|
.05 Meters/sec
Interval -0.01 to 0.11
|
|
Change in SPEED
3 weeks
|
-.04 Meters/sec
Interval -0.09 to 0.0
|
.08 Meters/sec
Interval 0.02 to 0.14
|
|
Change in SPEED
6 weeks (washout)
|
-.01 Meters/sec
Interval -0.06 to 0.03
|
.06 Meters/sec
Interval 0.0 to 0.12
|
SECONDARY outcome
Timeframe: after 3 weeks of ongoing training, after 6 weeks of ongoing trainingTo assess a change pain, participants completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and after 3 and 6 weeks of training with insoles; 0 representing extreme problems and 100 representing no problems
Outcome measures
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Change in Knee Pain
3 week time point
|
4.3 units on a scale from 0 to 100
Interval -4.2 to 12.8
|
10.0 units on a scale from 0 to 100
Interval -1.8 to 21.7
|
|
Change in Knee Pain
6 week time point
|
7.0 units on a scale from 0 to 100
Interval -4.2 to 18.2
|
12.3 units on a scale from 0 to 100
Interval -2.7 to 27.3
|
SECONDARY outcome
Timeframe: after 3 weeks of ongoing training, after 6 weeks of ongoing trainingTo assess a change self-reported Functional status, participants completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, and after 3 and 6 weeks of training with insoles; 0 representing extreme problems and 100 representing no problems with Function in daily living, with a score of 100 as the optimal outcome with unlimited function. (change between baseline and 3 weeks, and the change between baseline and 6 weeks)
Outcome measures
| Measure |
Flexible Shoe With Active Insole
n=26 Participants
Subjects will be trained to change the plantar pressure using a flexible walking shoe with an activated pressure-detecting shoe insole (Moticon OpenGO insole).
Active Moticon OpenGO insole: A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
|
Flexible Shoe With Passive Insole
n=12 Participants
A flexible walking shoe with a passive pressure-detecting shoe insole will be used for a comparator group.
Passive shoe insole: A deactivated insole measures shoe pressure only.
|
|---|---|---|
|
Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training
3 weeks
|
8.5 units on a scale, from 0 to 100
Interval 0.4 to 16.6
|
8.5 units on a scale, from 0 to 100
Interval -2.6 to 19.6
|
|
Change in Self-reported Functional Status Between Baseline, After 3 Weeks of Training, and After 6 Weeks of Training
6 weeks
|
15.6 units on a scale, from 0 to 100
Interval 6.1 to 25.0
|
6.7 units on a scale, from 0 to 100
Interval -6.3 to 19.7
|
Adverse Events
Flexible Shoe With Active Insole
Flexible Shoe With Passive Insole
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Markus Wimmer, Director Motion Analysis Laboratory
Rush University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place