Comparison Between Two Mobilization Techniques of Ankle on Balance in Patients With Chronic Ankle Instability
Primary Purpose
Ankle Sprains
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Experimental MWM
Experimental Thrust
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Sprains
Eligibility Criteria
Inclusion Criteria:
- Be a regular practitioner of some sporting modality (with a minimum of one year of practice and training frequency of twice a week), with a history of at least one unilateral ankle sprain with episodes of pain and decreased function, as well as a subjective report of Ankle instability (sensation of falsehood) after ligament injury associated with a result lower than 24 points in the Portuguese version of the Cumberland Ankle Instability Tool - CAIT
Exclusion Criteria:
- Participants with acute or subacute lesions and / or lower limb surgery.
Sites / Locations
- Universidade Federal do CearáRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Experimental MWM
Experimental Thrust
Placebo
Arm Description
Other names: 4 mobilizations - 10 seconds 20 seconds of rest
Other names: 1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion.
Other names: It will accurately reproduce the positioning of the hand in the specific treatment condition (Thrust or MWM), however, without applying any movement or force. All interactions, procedures and deadlines will be identical.
Outcomes
Primary Outcome Measures
Balance assessed with Biodex Balance System
Balance assessed with Biodex Balance System (stabilometry plattaform)
Secondary Outcome Measures
Full Information
NCT ID
NCT03079804
First Posted
March 6, 2017
Last Updated
October 24, 2017
Sponsor
Universidade Federal do Ceara
1. Study Identification
Unique Protocol Identification Number
NCT03079804
Brief Title
Comparison Between Two Mobilization Techniques of Ankle on Balance in Patients With Chronic Ankle Instability
Official Title
Comparison Between Two Mobilization Techniques With and Without Ankle Thrust on Balance in Patients With Chronic Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara
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
The ankle joint is often affected by injuries, especially lateral sprains, often leading to chronic instability. Joint mobilization techniques seem to influence the sense of joint positioning. The objective of the study is to compare mobilization techniques in the balance of athletes with chronic ankle instability. A randomized clinical trial with participants allocated in three groups: Talocrural manipulation, mobilization with movement and placebo will be assessed in their primary endpoints and secondary balance and dorsiflexion range of motion respectively.
Detailed Description
Biodex Balance System: The unipodal stability protocol was used in the anteroposterior and laterolateral directions. The test lasts for 20 seconds with five levels of instability, with level six being more stable and level two more unstable. The participant performed an adaptation test with the system and subsequently assessed the performance of the balance in three tests in each limb between each 10-second test. This will be instructed about the positioning during its evaluation, being oriented to keep the gaze in the previous direction; Hands on waist; Contralateral knee flexed at 90º, foot positioning is referenced in degrees on the platform as anthropometric information provided on the participant. At the end, the results of the anteroposterior and lateral-lateral directions and the general index were collected.
Weight Bearing Lunge Test (WBLT): The WBLT consisting of the use of a tape measure has no soil in which the participant will support or be evaluated so that the first finger touches On the tape and its distance to a reference wall for tape measurement. Required that the participant performs ankle dorsiflexion in CCF with the purpose of approaching the knee in the wall avoiding to remove the heel of the ground, that is on a marking.
Y test: To evaluate the dynamic balance and reach of lower limbs will be used The test balance consisting of the evaluation of the participant's performance during the movements of anterior, posteromedial and posterolateral angle with the value measured in centimeters with metric tapes In Direction.
The protocol performed six replicates for adaptation and one final repeat that is considered as a result of the test. For an earlier point, the reference point used is not support for a fixed reference point for the intersection of the conditions and for two other directions used. It is necessary that the participant be the same as the member farthest from the starting point without touching the tape. At the end of the seventh repetition is measured or value and considered the test result.
Intervention: Participants are divided into three groups: Thrust Group in open kinetic chain; MWM group in closed kinetic chain and control group with placebo intervention. Allocation in one of the groups will be randomized by lot.
Taken as applications of the questionnaires and initial evaluations (BBS, WBLT, Y Test), the assays receive a specific technique, are reassessed with the BBS and WBLT.
Talocrural manipulation: The technique of talocrural manipulation consists in the application of traction with a high caudal direction. Follow with the participant in supine position and as two hands to therapist around the talocrural joint, fifth finger in the anterior talar region and the two thumbs in the plantar area do the participant performing a manipulation in the affected limb. It is not considered an audible cavitation presence.
Mobilization with Motion (MWM): The Mulligan® concept-mobilized manual therapy technique follows the following protocol: the athlete is positioned on a stretcher with the limb treated in hip and knee flexion and the contralateral limb in knee flexion And neutral hip. With the use of a belt in the hip region of the physiotherapist and on a distal tibiofibular joint of the participant and bulkhead between the limb and the belt, they are placed as two hands of the physiotherapist superimposed non-talus for stabilization. With the posterior removal of the physiotherapist's hip a distal end of the tibia and fibula will be tractioned and maintained anteriorly, while requested that the participant performed an active knee flexion movement in a closed kinetic chain in order to force the movement of ankle dorsiflexion And thus, once the end point for the purpose, a mobilization will be held for 10 seconds. The patient will return to the starting point resting for 20 seconds for a next mobilization. In all, 4 separate mobilizations.
Placebo intervention: The positioning of the hand in the specific treatment condition (Thrust or MWM) will be accurately reproduced, however, without any movement or force being applied. All interactions, procedures and deadlines are identical.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Masking Description
Opaque envelopes
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental MWM
Arm Type
Experimental
Arm Description
Other names:
4 mobilizations - 10 seconds 20 seconds of rest
Arm Title
Experimental Thrust
Arm Type
Active Comparator
Arm Description
Other names:
1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Other names:
It will accurately reproduce the positioning of the hand in the specific treatment condition (Thrust or MWM), however, without applying any movement or force. All interactions, procedures and deadlines will be identical.
Intervention Type
Other
Intervention Name(s)
Experimental MWM
Intervention Description
Mobilization with Movement
Intervention Type
Other
Intervention Name(s)
Experimental Thrust
Intervention Description
Mobilization grade 5 (Thrust)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Procedures similar to Experimental MWM group, but without aplly any force
Primary Outcome Measure Information:
Title
Balance assessed with Biodex Balance System
Description
Balance assessed with Biodex Balance System (stabilometry plattaform)
Time Frame
almost 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be a regular practitioner of some sporting modality (with a minimum of one year of practice and training frequency of twice a week), with a history of at least one unilateral ankle sprain with episodes of pain and decreased function, as well as a subjective report of Ankle instability (sensation of falsehood) after ligament injury associated with a result lower than 24 points in the Portuguese version of the Cumberland Ankle Instability Tool - CAIT
Exclusion Criteria:
Participants with acute or subacute lesions and / or lower limb surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Lima, PhD
Phone
5585988643219
Email
pedrolima@ufc.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Lima, PhD
Organizational Affiliation
UFC - DEFISIO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60416130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro O Lima, Professor
Phone
5585988643219
Ext
55
Email
pedrofisioterapia@hotmail.com
First Name & Middle Initial & Last Name & Degree
Laísa B Maia, Student
Phone
5585986786898
Ext
55
Email
fisiolaisa@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison Between Two Mobilization Techniques of Ankle on Balance in Patients With Chronic Ankle Instability
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