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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
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 14, 2017
Last Updated
December 8, 2019
Sponsor
University of Jaén
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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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