Rehabilitation After Ankle InjuriesNCT03038815
The Influence of Stability Boots on Gait Pattern in Healthy Adults
A study testing VACOped and Ortho Tri in people with Rehabilitation After Ankle Injuries, run by Institute for Biomechanics, ETH Zürich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation After Ankle Injuries
- What is being tested?
- VACOped and Ortho Tri
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- 18-45 years old
- shoe size 5,6,9 or 10
Who cannot join
- injuries of the lower limbs
- previous surgeries on the lower limbs
- neuromuscular disorders
- restriction in gait capabilities
- current medical treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institute for Biomechanics ETH Zürich
Zurich, Canton of Zurich, 8093
About this study
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.
Read the 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.
- Conditions
- Rehabilitation After Ankle Injuries
- Being tested
- VACOped, Ortho Tri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACOpedDevice
restriction of ankle joint motion
Ortho TriDevice
restriction of ankle joint motion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: VACOped; Device: 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 Receives: Device: VACOped; Device: Ortho Tri |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM Ankle Joint
Ankle joint motion ROM Sagittal left, during gait
Measured: duration of a session is typically 3 hours
Secondary outcomes (1)
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.
Measured: duration of a session is typically 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rehabilitation After Ankle InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Biomechanics, ETH Zürich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvio Lorenzetti, PhD, Principal investigator, Institute for Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038815
- Sponsor's protocol ID
- Stability Boots
- Status last verified
- Nov 2019
- First submitted
- 25 Jan 2017
- Last updated
- 18 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Stability Boots on Gait Pattern in Healthy Adults
- ClinicalTrials.gov ID
- NCT03038815
- Acronym / sponsor ID
- Stability Boots
- Conditions
- Rehabilitation After Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute for Biomechanics, ETH ZürichUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Posted 1 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controll-VACOped-Ortho Tri | Experimental | Device: VACOped, Device: Ortho TriAll 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 | Device: VACOped, Device: Ortho TriAll 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- 18-45 years old
- shoe size 5,6,9 or 10
Key exclusion criteria (5 listed)
- injuries of the lower limbs
- previous surgeries on the lower limbs
- neuromuscular disorders
- restriction in gait capabilities
- current medical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VACOpedrestriction of ankle joint motion | Device | Controll-Ortho Tri-VACOped, Controll-VACOped-Ortho Tri |
| Ortho Trirestriction of ankle joint motion | Device | Controll-Ortho Tri-VACOped, Controll-VACOped-Ortho Tri |
Primary outcome
ROM Ankle Joint
Time frame: duration of a session is typically 3 hours
Ankle joint motion ROM Sagittal left, during gait
1 secondary outcome
Symmetrie Index
Time frame: duration of a session is typically 3 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Simplified Post Op Rehabilitation for Ankle and Pilon Fractures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvio Lorenzetti, PhD principal investigator
Institute for Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VACOped and Ortho Tri in people with Rehabilitation After Ankle Injuries, run by Institute for Biomechanics, ETH Zürich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM Ankle Joint (time frame: duration of a session is typically 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.