- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189784
Ankle Instability Treatment in Patients With Chronic Ankle Instability
December 8, 2019 updated by: DAVID CRUZ DÍAZ, University of Jaén
Mobilization With Movement Treatment in Patients With Chronic Ankle Instability
Ankle joint self mobilization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jaen, Spain, 23071
- University of Jaén
-
Jaen, Spain, 23009
- University of Jaen campus
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- recent fractures of the involved limb.
- Vestibular or balance dysfunction.
- Acute ankle sprain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mobilization group
this group will receive mobilization with movement techniques.
|
patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion
Other Names:
|
|
No Intervention: Control group
The control group will receive no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dynamic balance
Time Frame: from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
|
Dynamic balance will be determined by the star excursion balance test
|
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.
|
Self reported instability will be assessed by the Cumberland ankle instability tool
|
from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2018
Primary Completion (Actual)
March 30, 2018
Study Completion (Actual)
April 2, 2019
Study Registration Dates
First Submitted
June 14, 2017
First Submitted That Met QC Criteria
June 14, 2017
First Posted (Actual)
June 16, 2017
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 8, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ankle ujaen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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