Ankle InjuriesNCT03189784
Ankle Instability Treatment in Patients With Chronic Ankle Instability
A study testing mobilization with movement techniques in people with Ankle Injuries, run by University of Jaén at 2 sites in Spain.
Trial summary
Ankle joint self mobilization. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- mobilization with movement techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Feb 2018to 2 Apr 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ankle range of motion limitation respect the contralateral ankle.
- At least two episodes of giving way on the affected ankle.
- Scores of at least 24 in the cumberland ankle instability tool.
Who cannot join
- recent fractures of the involved limb.
- Vestibular or balance dysfunction.
- Acute ankle sprain.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Jaen campus
Jaén, 23009
University of Jaen
Jaén, 23071
About this study
Official title: Mobilization With Movement Treatment in Patients With Chronic Ankle Instability
Ankle joint self mobilization.
Read the detailed description
The intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program
- Conditions
- Ankle Injuries
- Being tested
- mobilization with movement techniques
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization with movement techniquesOther
Also called Joint mobilizations
patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion
| Study group | Role | What they receive |
|---|---|---|
| mobilization group | Experimental | this group will receive mobilization with movement techniques. Receives: Other: mobilization with movement techniques |
| Control group | No intervention | The control group will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
the ankle range of motion will be measured by goniometry.
Measured: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Secondary outcomes (2)
dynamic balance
Dynamic balance will be determined by the star excursion balance test
Measured: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Self reported instability
Self reported instability will be assessed by the Cumberland ankle instability tool
Measured: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start15 Feb 2018
- Primary completion30 Mar 2018
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAVID CRUZ DÍAZ, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189784
- Sponsor's protocol ID
- ankle ujaen
- Status last verified
- Dec 2019
- First submitted
- 14 Jun 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization With Movement Treatment in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03189784
- Acronym / sponsor ID
- ankle ujaen
- Conditions
- Ankle Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 16 Jun 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.
Ankle joint self mobilization.
Detailed description
The intervention would consist in the administration of self mobilization with movement techniques in patients with chronic ankle instability in addition to an exercise program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| mobilization group | Experimental | Other: mobilization with movement techniquesthis group will receive mobilization with movement techniques. |
| Control group | No intervention | –The control group will receive no intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ankle range of motion limitation respect the contralateral ankle.
- At least two episodes of giving way on the affected ankle.
- Scores of at least 24 in the cumberland ankle instability tool.
Key exclusion criteria (3 listed)
- recent fractures of the involved limb.
- Vestibular or balance dysfunction.
- Acute ankle sprain.
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 |
|---|---|---|
| mobilization with movement techniquesAlso: Joint mobilizationspatient will receive an anteroposterior stimuli in the talus in order to restore the range of motion | Other | mobilization group |
Primary outcome
range of motion
Time frame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
the ankle range of motion will be measured by goniometry.
2 secondary outcomes
dynamic balance
Time frame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Self reported instability
Time frame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
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 10 Dec 2019.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization with movement techniques in people with Ankle Injuries, run by University of Jaén at 2 sites in Spain.
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 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 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
range of motion (time frame: from baseline prior to the beginning of the intervention to the completion of the study at four 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 10 Dec 2019.