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After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle support limit the range of motion in the joint, help pain relief, control loading of the injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable accurate analysis of human movement.
The study is set to describe and compare the gait analysis of two modifiable stability boots (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.
The participants are joining one session in the gait lab. Here the are measured during walking with normal shoes and two modifiable stability boots. The duration of a session is typically 3 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controll-VACOped-Ortho Tri | Experimental | 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 VACOped as the first intervention. |
|
| Controll-Ortho Tri-VACOped | Experimental | 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 first intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VACOped | Device | restriction of ankle joint motion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ROM Ankle Joint | Ankle joint motion ROM Sagittal left, during gait | duration of a session is typically 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Symmetrie Index | The 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. | duration of a session is typically 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvio Lorenzetti, PhD | Institute for Biomechanics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Biomechanics ETH Zürich | Zurich | Canton of Zurich | 8093 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Controll-VACOped-Ortho Tri | VACOped first |
| FG001 | Controll-Ortho Tri-VACOped | Ortho Tri first |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controll Condition, 1 Hour |
| |||||||||||||
| Intervention 1, 1 Hour |
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| Intervention 2, 1 Hour |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group-VACOped-Ortho Tri-Phase | 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. |
| BG001 | Control Group-Ortho Tri-Phase-VACOped |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ROM Ankle Joint | Ankle joint motion ROM Sagittal left, during gait | Posted | Mean | Standard Deviation | degree | duration of a session is typically 3 hours |
|
during the intervention, up to 3 hours
Standard definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controll-VACOped-Ortho Tri | This group had first the control condition, than the VACUped intervention and last the Ortho Tri intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Silvio Lorenzetti | Institute for Biomechanics ETH Zürich | 078 608 14 84 | sl@ethz.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2017 | Jun 27, 2019 | Prot_SAP_000.pdf |
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| Ortho Tri | Device | restriction of ankle joint motion |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ortho Tri-Phase |
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 |
|
|
| Secondary | Symmetrie Index | The 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. | Posted | Mean | Standard Deviation | percentage of step length | duration of a session is typically 3 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Controll-Ortho Tri-VACOped | This group had first the control condition, than the Ortho Tri intervention and last the VACOped intervention. | 0 | 10 | 0 | 10 | 0 | 10 |
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