The Influence of Stability Boots on Gait Pattern in Healthy Adults
Primary Purpose
Rehabilitation After Ankle Injuries
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
VACOped
Ortho Tri
Sponsored by
About this trial
This is an interventional basic science trial for Rehabilitation After Ankle Injuries
Eligibility Criteria
Inclusion Criteria:
- healthy
- 18-45 years old
- shoe size 5,6,9 or 10
Exclusion Criteria:
- injuries of the lower limbs
- previous surgeries on the lower limbs
- neuromuscular disorders
- restriction in gait capabilities
- current medical treatment
Sites / Locations
- Institute for Biomechanics ETH Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Controll-VACOped-Ortho Tri
Controll-Ortho Tri-VACOped
Arm Description
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.
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
Outcomes
Primary Outcome Measures
ROM Ankle Joint
Ankle joint motion ROM Sagittal left, during gait
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03038815
First Posted
January 25, 2017
Last Updated
November 1, 2019
Sponsor
Institute for Biomechanics, ETH Zürich
1. Study Identification
Unique Protocol Identification Number
NCT03038815
Brief Title
The Influence of Stability Boots on Gait Pattern in Healthy Adults
Official Title
The Influence of Stability Boots on Gait Pattern in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Biomechanics, ETH Zürich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation After Ankle Injuries
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controll-VACOped-Ortho Tri
Arm Type
Experimental
Arm Description
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.
Arm Title
Controll-Ortho Tri-VACOped
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
VACOped
Intervention Description
restriction of ankle joint motion
Intervention Type
Device
Intervention Name(s)
Ortho Tri
Intervention Description
restriction of ankle joint motion
Primary Outcome Measure Information:
Title
ROM Ankle Joint
Description
Ankle joint motion ROM Sagittal left, during gait
Time Frame
duration of a session is typically 3 hours
Secondary Outcome Measure Information:
Title
Symmetrie Index
Description
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.
Time Frame
duration of a session is typically 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy
18-45 years old
shoe size 5,6,9 or 10
Exclusion Criteria:
injuries of the lower limbs
previous surgeries on the lower limbs
neuromuscular disorders
restriction in gait capabilities
current medical treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvio Lorenzetti, PhD
Organizational Affiliation
Institute for Biomechanics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Biomechanics ETH Zürich
City
Zurich
State/Province
ZH
ZIP/Postal Code
8093
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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The Influence of Stability Boots on Gait Pattern in Healthy Adults
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