The Influence of Stability Boots on Gait Pattern in Healthy Adults

November 1, 2019 updated by: Institute for Biomechanics, ETH Zürich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8093
        • Institute for Biomechanics ETH Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Controll-VACOped-Ortho Tri
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.
Device: VACOped
restriction of ankle joint motion
Device: Ortho Tri
restriction of ankle joint motion
EXPERIMENTAL: Controll-Ortho Tri-VACOped
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
Device: VACOped
restriction of ankle joint motion
Device: Ortho Tri
restriction of ankle joint motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM Ankle Joint
Time Frame: duration of a session is typically 3 hours
Ankle joint motion ROM Sagittal left, during gait
duration of a session is typically 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symmetrie Index
Time Frame: duration of a session is typically 3 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Biomechanics, ETH Zürich

Investigators

  • Principal Investigator: Silvio Lorenzetti, PhD, Institute for Biomechanics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stability Boots

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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