The Influence of Stability Boots on Gait Pattern in Healthy Adults

NCT ID: NCT03038815

Last Updated: 2019-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rehabilitation After Ankle Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VACOped

Intervention Type DEVICE

restriction of ankle joint motion

Ortho Tri

Intervention Type DEVICE

restriction of ankle joint motion

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

Group Type EXPERIMENTAL

VACOped

Intervention Type DEVICE

restriction of ankle joint motion

Ortho Tri

Intervention Type DEVICE

restriction of ankle joint motion

Interventions

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VACOped

restriction of ankle joint motion

Intervention Type DEVICE

Ortho Tri

restriction of ankle joint motion

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute for Biomechanics, ETH Zürich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvio Lorenzetti, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Biomechanics

Locations

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Institute for Biomechanics ETH Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Stability Boots

Identifier Type: -

Identifier Source: org_study_id

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