Gait, FrontalNCT03393923
Anterior Wedge in Patients With Osteoarthritis Hip
A study testing Application of the anterior wedge in people with Gait, Frontal, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Gait, Frontal
- What is being tested?
- Application of the anterior wedge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2017to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedentary individuals
- Both genders
- Age equal to or greather than 50 years
- Diagnosis of osteoarthritis level II and III
Who cannot join
- fractures
- Neuromuscular diseases
- Other diseases of hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anterior Wedge Use in Patients With Osteoarthritis Hip
Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze of gait through of Myovídeo analysis software.
- Conditions
- Gait, Frontal
- Being tested
- Application of the anterior wedge
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the anterior wedgeOther
Application of anterior wedge in tennis
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patient will undergo gait analysis |
| Experimental group | Experimental | Patient will undergo gait analysis with use of anterior wedge Receives: Other: Application of the anterior wedge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inproved performance of the gluteus maximus
Extent moment will be assessed by gait analysis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start10 Jul 2017
- Primary completion1 Jan 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, FrontalStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393923
- Sponsor's protocol ID
- 1112131232234
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anterior Wedge Use in Patients With Osteoarthritis Hip
- ClinicalTrials.gov ID
- NCT03393923
- Acronym / sponsor ID
- 1112131232234
- Conditions
- Gait, Frontal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ostearthritis is a great source of pain. In symptomatic hip the pain can lead the major disability and poor quality of life. Understand the musculoskeletal factores can lead to a better clinical management. The muscle strenghening of posterolateral complexo of hip is a important consideration. General Objective: Perform a Kinetic analysis 2D using na anterior wedge. Specific objective: Analyze the influence of posterolateral hip complex. Controlled clinical trial, composed by 30 individuals with and without osteoarthritis of hip e will be used a tools; Analogic Visual Scale, manual dynamometry to analyze force and kinetic analyze of gait through of Myovídeo analysis software.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patient will undergo gait analysis |
| Experimental group | Experimental | Other: Application of the anterior wedgePatient will undergo gait analysis with use of anterior wedge |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedentary individuals
- Both genders
- Age equal to or greather than 50 years
- Diagnosis of osteoarthritis level II and III
Key exclusion criteria (3 listed)
- fractures
- Neuromuscular diseases
- Other diseases of hip
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 |
|---|---|---|
| Application of the anterior wedgeApplication of anterior wedge in tennis | Other | Experimental group |
Primary outcome
Inproved performance of the gluteus maximus
Time frame: 24 hours
Extent moment will be assessed by gait analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of the anterior wedge in people with Gait, Frontal, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 4 inclusion and 3 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 26 Feb 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inproved performance of the gluteus maximus (time frame: 24 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 26 Feb 2019.