Chronic Instability of JointNCT01618032
Effects of Two Techniques of Mobilization in the Dorsiflexion on Patients With Chronic Ankle Instability
A study testing HVLA and MWM in people with Chronic Instability of Joint, run by CEU San Pablo University.
Trial summary
Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Chronic Instability of Joint
- What is being tested?
- HVLA and MWM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Nov 2012
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with chronic ankle instability
Who cannot join
- Acute or subacute ankle sprain.
- Recent lesions in lower extremities.
About this study
Official title: The Effects of Two Techniques of Mobilization in the Improvement of Dorsiflexion on Chronic Instability Ankles. A Double Blind Randomized Controlled Trial
Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability.
The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.
- Conditions
- Chronic Instability of Joint
- Being tested
- HVLA, MWM, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLAOther
High velocity and low amplitude manipulation in traction of subtalar jonit
MWMOther
Mobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing
placeboOther
Manual contact during a period of time similar of teh other interventions
| Study group | Role | What they receive |
|---|---|---|
| HVLA | Experimental | High velocity and low amplitude traction manipulation on the ankle joint Receives: Other: HVLA |
| MWM | Experimental | Mobilization with movement on ankle joint as Mulligan Receives: Other: MWM |
| placebo | Sham comparator | Contact without therapeutic effect Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-intervention ankle dorsiflexion
Ankle dorsiflexion is measured by the weight-bearing lunge method
Measured: pre-intervention
Inmediately post-intervention ankle dorsiflexion
Ankle dorsiflexion is measured by the weight-bearing lunge method
Measured: inmediately post-intervention
ten minutes post-intervention ankle dorsiflexion
Ankle dorsiflexion is measured by the weight-bearing lunge method
Measured: ten minutes post-intervention
24 hr post-intervention ankle dorsiflexion
Ankle dorsiflexion is measured by the weight-bearing lunge method
Measured: 24 hr post-intervention
48 hr post-intervention ankle dorsiflexion
Ankle dorsiflexion is measured by the weight-bearing lunge method
Measured: 48 hr post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Instability of 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Luis Rodriguez, CEU San Pablo University
- Investigators
- Ángel L Rodríguez-Fernández, PT, MSc, Principal investigator, CEU San Pablo UniversityDavid Marrón-Gómez, PT, MSc, Study chair, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618032
- Sponsor's protocol ID
- CEU-002
- Status last verified
- Nov 2012
- First submitted
- 8 Jun 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Techniques of Mobilization in the Improvement of Dorsiflexion on Chronic Instability Ankles. A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01618032
- Acronym / sponsor ID
- CEU-002
- Conditions
- Chronic Instability of Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Jun 2012 (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.
Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability.
The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HVLA | Experimental | Other: HVLAHigh velocity and low amplitude traction manipulation on the ankle joint |
| MWM | Experimental | Other: MWMMobilization with movement on ankle joint as Mulligan |
| placebo | Sham comparator | Other: placeboContact without therapeutic effect |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subjects with chronic ankle instability
Key exclusion criteria (2 listed)
- Acute or subacute ankle sprain.
- Recent lesions in lower extremities.
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 |
|---|---|---|
| HVLAHigh velocity and low amplitude manipulation in traction of subtalar jonit | Other | HVLA |
| MWMMobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing | Other | MWM |
| placeboManual contact during a period of time similar of teh other interventions | Other | placebo |
Primary outcome
Pre-intervention ankle dorsiflexion
Time frame: pre-intervention
Ankle dorsiflexion is measured by the weight-bearing lunge method
Inmediately post-intervention ankle dorsiflexion
Time frame: inmediately post-intervention
Ankle dorsiflexion is measured by the weight-bearing lunge method
ten minutes post-intervention ankle dorsiflexion
Time frame: ten minutes post-intervention
Ankle dorsiflexion is measured by the weight-bearing lunge method
24 hr post-intervention ankle dorsiflexion
Time frame: 24 hr post-intervention
Ankle dorsiflexion is measured by the weight-bearing lunge method
48 hr post-intervention ankle dorsiflexion
Time frame: 48 hr post-intervention
Ankle dorsiflexion is measured by the weight-bearing lunge method
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 3 Dec 2012.
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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.
Ángel L Rodríguez-Fernández, PT, MSc principal investigator
CEU San Pablo University
David Marrón-Gómez, PT, MSc study chair
CEU San Pablo University
Questions about this trial
What is this clinical trial studying?
A study testing HVLA and MWM in people with Chronic Instability of Joint, run by CEU San Pablo University.
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 2 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 3 Dec 2012. 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?
Pre-intervention ankle dorsiflexion (time frame: pre-intervention). The study lists 5 primary outcomes in all. 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 3 Dec 2012.