Hip JointNCT03115879
The Effect High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology
A study testing Hip mobilization and Hip manipulation simulation in people with Hip Joint and Muscle Weakness, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo.
Trial summary
Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause activity limitations. Physical therapy intervention in the form of exercise is commonly directed at improving muscular performance, however, neuromuscular adaptations may limit the effectiveness of traditional strengthening… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Joint, Muscle Weakness
- What is being tested?
- Hip mobilization and Hip manipulation simulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Oct 2016
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals with a lower extremity pathology volunteered for this study
- Being greater than 18 years of age
- 10% decrease in muscle strength in symptomatic side compared to healthy side
- Absence of medical precautions that would prevent a maximal effort strength test.
Who cannot join
- Included individuals with a history lower extremity arthroplasty.
- Recent muscle or tendon ruptures (within the past 6 months)
- Unhealed fractures
- Neurological diseases
- Malignant cancer
- Osteoporosis
- Active infections processes
- Early postoperative knee, hip and ankle surgery with range of motion and weight bearing restrictions.
About this study
Official title: The Effect of High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology
Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause activity limitations. Physical therapy intervention in the form of exercise is commonly directed at improving muscular performance, however, neuromuscular adaptations may limit the effectiveness of traditional strengthening exercises. Manual therapy techniques have been used as a disinhibitory intervention to increase muscle activation and strength before participating in strengthening exercises or performing functional tasks While there is recent evidence to support joint mobilization as a valuable manual therapy disinhibitory intervention Currently, there is no evidence to substantiate anecdotal experience that a HVLAT hip distraction mobilization improves muscle performance in subjects with lower extremity pathology and lower extremity weakness. The purpose of this study was to determine if a HVLAT hip distraction mobilization would result in an immediate change of maximal force output of the quadriceps, gluteus maximus and gluteus medius.
Methods: Forty individuals with a lower extremity pathology volunteered for this study. Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18 years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side, and absence of medical precautions that would prevent a maximal effort strength test and exclusion criteria included individuals with a history lower extremity recent muscle or tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery. Demographic data, including diagnosis from referring physician were collected. All subjects completed the Lower extremity function scale (LEFS). A single evaluator blinded to the involved extremity was responsible for quadriceps, gluteus medius and maximus strength analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate re-assessment of strength of both symptomatic and non-symptomatic sides followed the mobilization.
- Conditions
- Hip Joint, Muscle Weakness
- Being tested
- Hip mobilization, Hip manipulation simulation
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip mobilizationOther
High velocity low amplitude hip mobilization of the experimental group
Hip manipulation simulationOther
Hip manipulation simulation
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Hip manipulation simulation Receives: Other: Hip manipulation simulation |
| Manipulation Group | Experimental | Hip manipulation Receives: Other: Hip mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
A Lafayette dynamometer was used to evaluate the maximum isometric torque of the muscles
Measured: Assessment of muscle strength was performed after 10 minutes of manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startFeb 2015
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip JointStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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, Diego Galace de Freitas, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115879
- Sponsor's protocol ID
- DFreitas
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 14 Apr 2017
- 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology
- ClinicalTrials.gov ID
- NCT03115879
- Acronym / sponsor ID
- DFreitas
- Conditions
- Hip Joint, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Apr 2017 (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.
Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause activity limitations. Physical therapy intervention in the form of exercise is commonly directed at improving muscular performance, however, neuromuscular adaptations may limit the effectiveness of traditional strengthening exercises. Manual therapy techniques have been used as a disinhibitory intervention to increase muscle activation and strength before participating in strengthening exercises or performing functional tasks While there is recent evidence to support joint mobilization as a valuable manual therapy disinhibitory intervention Currently, there is no evidence to substantiate anecdotal experience that a HVLAT hip distraction mobilization improves muscle performance in subjects with lower extremity pathology and lower extremity weakness. The purpose of this study was to determine if a HVLAT hip distraction mobilization would result in an immediate change of maximal force output of the quadriceps, gluteus maximus and gluteus medius.
Methods: Forty individuals with a lower extremity pathology volunteered for this study. Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18 years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side, and absence of medical precautions that would prevent a maximal effort strength test and exclusion criteria included individuals with a history lower extremity recent muscle or tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery. Demographic data, including diagnosis from referring physician were collected. All subjects completed the Lower extremity function scale (LEFS). A single evaluator blinded to the involved extremity was responsible for quadriceps, gluteus medius and maximus strength analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate re-assessment of strength of both symptomatic and non-symptomatic sides followed the mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Other: Hip manipulation simulationHip manipulation simulation |
| Manipulation Group | Experimental | Other: Hip mobilizationHip manipulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals with a lower extremity pathology volunteered for this study
- Being greater than 18 years of age
- 10% decrease in muscle strength in symptomatic side compared to healthy side
- Absence of medical precautions that would prevent a maximal effort strength test.
Key exclusion criteria (8 listed)
- Included individuals with a history lower extremity arthroplasty.
- Recent muscle or tendon ruptures (within the past 6 months)
- Unhealed fractures
- Neurological diseases
- Malignant cancer
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 |
|---|---|---|
| Hip mobilizationHigh velocity low amplitude hip mobilization of the experimental group | Other | Manipulation Group |
| Hip manipulation simulationHip manipulation simulation | Other | Placebo Group |
Primary outcome
Muscle strength
Time frame: Assessment of muscle strength was performed after 10 minutes of manipulation
A Lafayette dynamometer was used to evaluate the maximum isometric torque of the muscles
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 14 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hip mobilization and Hip manipulation simulation in people with Hip Joint and Muscle Weakness, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo.
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 8 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Muscle strength (time frame: Assessment of muscle strength was performed after 10 minutes of manipulation). 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 14 Apr 2017.