Transversus Abdominis ActivationPhase 1/2NCT01481857
Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training
A Phase 1/2 study testing Segmental trunk exercise associated with proprioception and Segmental trunk exercise in people with Transversus Abdominis Activation, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Transversus Abdominis Activation
- What is being tested?
- Segmental trunk exercise associated with proprioception and Segmental trunk exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to May 2011
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- subjects with any kind of disease
Trial locations and contacts
1 site in 1 country.
About this study
Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training.
- Conditions
- Transversus Abdominis Activation
- Being tested
- Segmental trunk exercise associated with proprioception, Segmental trunk exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental trunk exercise associated with proprioceptionOther
Proprioceptive exercise
Segmental trunk exerciseOther
Segmental trunk exercise
| Study group | Role | What they receive |
|---|---|---|
| Thoracolumbar proprioception | Experimental | Not described Receives: Other: Segmental trunk exercise associated with proprioception |
| Segmental Stabilization | Experimental | Not described Receives: Other: Segmental trunk exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of transversus abdominis
Activation of transverus abdominis will be assessed by the biofeedback pressure unit.Pressure biofeedback units consist of a combined inflation bulb connected to a pressure cell.
Measured: Two Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis ActivationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuad Ahmad Hazime, Universidade Federal do Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481857
- Sponsor's protocol ID
- 0378.0.045.000-10
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training
- ClinicalTrials.gov ID
- NCT01481857
- Acronym / sponsor ID
- 0378.0.045.000-10
- Conditions
- Transversus Abdominis Activation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Nov 2011 (estimated)
- 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.
Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracolumbar proprioception | Experimental | Other: Segmental trunk exercise associated with proprioception |
| Segmental Stabilization | Experimental | Other: Segmental trunk exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- subjects with any kind of disease
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 |
|---|---|---|
| Segmental trunk exercise associated with proprioceptionProprioceptive exercise | Other | Thoracolumbar proprioception |
| Segmental trunk exerciseSegmental trunk exercise | Other | Segmental Stabilization |
Primary outcome
Activation of transversus abdominis
Time frame: Two Weeks
Activation of transverus abdominis will be assessed by the biofeedback pressure unit.Pressure biofeedback units consist of a combined inflation bulb connected to a pressure cell.
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 30 Nov 2011.
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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 Phase 1/2 study testing Segmental trunk exercise associated with proprioception and Segmental trunk exercise in people with Transversus Abdominis Activation, run by Universidade Federal do Piauí 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 1 inclusion and 1 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 30 Nov 2011. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Activation of transversus abdominis (time frame: Two Weeks). 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 30 Nov 2011.