Trial Outcomes & Findings for The Influence of Stability Boots on Gait Pattern in Healthy Adults (NCT NCT03038815)
NCT ID: NCT03038815
Last Updated: 2019-11-18
Results Overview
Ankle joint motion ROM Sagittal left, during gait
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
duration of a session is typically 3 hours
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
Controll-VACOped-Ortho Tri
VACOped first
|
Controll-Ortho Tri-VACOped
Ortho Tri first
|
|---|---|---|
|
Controll Condition, 1 Hour
STARTED
|
10
|
10
|
|
Controll Condition, 1 Hour
COMPLETED
|
10
|
10
|
|
Controll Condition, 1 Hour
NOT COMPLETED
|
0
|
0
|
|
Intervention 1, 1 Hour
STARTED
|
10
|
10
|
|
Intervention 1, 1 Hour
COMPLETED
|
10
|
10
|
|
Intervention 1, 1 Hour
NOT COMPLETED
|
0
|
0
|
|
Intervention 2, 1 Hour
STARTED
|
10
|
10
|
|
Intervention 2, 1 Hour
COMPLETED
|
10
|
10
|
|
Intervention 2, 1 Hour
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group-VACOped-Ortho Tri-Phase
n=10 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
This group had the VACUped as first intervention.
|
Control Group-Ortho Tri-Phase-VACOped
n=10 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
This group had the Ortho Tri as first intervention.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
24 years
STANDARD_DEVIATION 2 • n=10 Participants
|
24 years
STANDARD_DEVIATION 2 • n=10 Participants
|
24 years
STANDARD_DEVIATION 2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: duration of a session is typically 3 hoursAnkle joint motion ROM Sagittal left, during gait
Outcome measures
| Measure |
Control Group
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
|
VACOped
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.
VACOped: restriction of ankle joint motion
|
Ortho Tri-Phase
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.
Ortho Tri-Phase: restriction of ankle joint motion
|
|---|---|---|---|
|
ROM Ankle Joint
|
31.4 degree
Standard Deviation 5.7
|
18.4 degree
Standard Deviation 3.5
|
21.2 degree
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: duration of a session is typically 3 hoursThe symmetrie index, represents the % difference step length, index= 2\*100\*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.
Outcome measures
| Measure |
Control Group
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed. For control, the participants are wearing Sport shoes.
|
VACOped
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.
VACOped: restriction of ankle joint motion
|
Ortho Tri-Phase
n=20 Participants
All participants are in the control and the two intervention group. The instant change of the ankle joint motion is analyzed.
Ortho Tri-Phase: restriction of ankle joint motion
|
|---|---|---|---|
|
Symmetrie Index
|
2.45 percentage of step length
Standard Deviation 0.05
|
7.62 percentage of step length
Standard Deviation 0.15
|
1.9 percentage of step length
Standard Deviation 0.04
|
Adverse Events
Controll-VACOped-Ortho Tri
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controll-Ortho Tri-VACOped
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Silvio Lorenzetti
Institute for Biomechanics ETH Zürich
Phone: 078 608 14 84
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place