Ankle Instability Treatment in Patients With Chronic Ankle Instability
Primary Purpose
Ankle Injuries
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
mobilization with movement techniques
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Injuries
Eligibility Criteria
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.
Sites / Locations
- University of Jaen campus
- University of Jaen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mobilization group
Control group
Arm Description
this group will receive mobilization with movement techniques.
The control group will receive no intervention
Outcomes
Primary Outcome Measures
range of motion
the ankle range of motion will be measured by goniometry.
Secondary Outcome Measures
dynamic balance
Dynamic balance will be determined by the star excursion balance test
Self reported instability
Self reported instability will be assessed by the Cumberland ankle instability tool
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03189784
Brief Title
Ankle Instability Treatment in Patients With Chronic Ankle Instability
Official Title
Mobilization With Movement Treatment in Patients With Chronic Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobilization group
Arm Type
Experimental
Arm Description
this group will receive mobilization with movement techniques.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive no intervention
Intervention Type
Other
Intervention Name(s)
mobilization with movement techniques
Other Intervention Name(s)
Joint mobilizations
Intervention Description
patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion
Primary Outcome Measure Information:
Title
range of motion
Description
the ankle range of motion will be measured by goniometry.
Time Frame
from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Secondary Outcome Measure Information:
Title
dynamic balance
Description
Dynamic balance will be determined by the star excursion balance test
Time Frame
from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
Title
Self reported instability
Description
Self reported instability will be assessed by the Cumberland ankle instability tool
Time Frame
from baseline prior to the beginning of the intervention to the completion of the study at four weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Jaen campus
City
Jaen
ZIP/Postal Code
23009
Country
Spain
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ankle Instability Treatment in Patients With Chronic Ankle Instability
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