NCT03038815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 1, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

January 25, 2017

Results QC Date

June 27, 2019

Last Update Submit

November 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • ROM Ankle Joint

    Ankle joint motion ROM Sagittal left, during gait

    duration of a session is typically 3 hours

Secondary Outcomes (1)

  • Symmetrie Index

    duration of a session is typically 3 hours

Study Arms (2)

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.

Device: VACOpedDevice: Ortho Tri

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

Device: VACOpedDevice: Ortho Tri

Interventions

VACOpedDEVICE

restriction of ankle joint motion

Controll-Ortho Tri-VACOpedControll-VACOped-Ortho Tri
Ortho TriDEVICE

restriction of ankle joint motion

Controll-Ortho Tri-VACOpedControll-VACOped-Ortho Tri

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • years old
  • shoe size 5,6,9 or 10

You may not qualify if:

  • injuries of the lower limbs
  • previous surgeries on the lower limbs
  • neuromuscular disorders
  • restriction in gait capabilities
  • current medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomechanics ETH Zürich

Zurich, Canton of Zurich, 8093, Switzerland

Location

Results Point of Contact

Title
Silvio Lorenzetti
Organization
Institute for Biomechanics ETH Zürich

Study Officials

  • Silvio Lorenzetti, PhD

    Institute for Biomechanics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 1, 2017

Study Start

February 1, 2017

Primary Completion

June 30, 2017

Study Completion

December 31, 2017

Last Updated

November 18, 2019

Results First Posted

November 1, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations