- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079804
Comparison Between Two Mobilization Techniques of Ankle on Balance in Patients With Chronic Ankle Instability
Comparison Between Two Mobilization Techniques With and Without Ankle Thrust on Balance in Patients With Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedro Lima, PhD
- Phone Number: 5585988643219
- Email: pedrolima@ufc.br
Study Locations
-
-
Ceará
-
Fortaleza, Ceará, Brazil, 60416130
- Recruiting
- Universidade Federal Do Ceara
-
Contact:
- Pedro O Lima, Professor
- Phone Number: 55 5585988643219
- Email: pedrofisioterapia@hotmail.com
-
Contact:
- Laísa B Maia, Student
- Phone Number: 55 5585986786898
- Email: fisiolaisa@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental MWM
Other names: 4 mobilizations - 10 seconds 20 seconds of rest |
Mobilization with Movement
Mobilization grade 5 (Thrust)
Procedures similar to Experimental MWM group, but without aplly any force
|
Active Comparator: Experimental Thrust
Other names: 1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion. |
Mobilization with Movement
Mobilization grade 5 (Thrust)
Procedures similar to Experimental MWM group, but without aplly any force
|
Placebo Comparator: Placebo
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. |
Mobilization with Movement
Mobilization grade 5 (Thrust)
Procedures similar to Experimental MWM group, but without aplly any force
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance assessed with Biodex Balance System
Time Frame: almost 10 minutes
|
Balance assessed with Biodex Balance System (stabilometry plattaform)
|
almost 10 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pedro Lima, PhD, UFC - DEFISIO
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POdePLima
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Ankle Sprains
-
Riphah International UniversityRecruiting
-
Riphah International UniversityRecruitingAnkle SprainsPakistan
-
MEDRx USA, Inc.CompletedAnkle SprainsUnited States
-
Centre Hospitalier Universitaire de Saint EtienneRecruiting
-
Taipei Medical University WanFang HospitalUnknown
-
Lazaros LazarouCompletedAnkle SprainsGreece
-
Universiteit AntwerpenUniversity Hospital, Antwerp; University of Ulster; Bern University of Applied...Recruiting
-
Christian OlsenUniversity of Copenhagen; University Hospital Bispebjerg and Frederiksberg; Regionshospitalet... and other collaboratorsUnknown
-
Logan University, Inc.Sport and Spine Rehab Clinical Research Foundation; Parker University; Brentwood...Terminated
-
Sylvia Maher Mohsen Farid HannaNot yet recruiting
Clinical Trials on Experimental MWM
-
Natália Maria Oliveira CampeloCompletedPathologic Processes | Musculoskeletal Diseases | Joint Disease | Osteoarthritis Hip
-
Imam Abdulrahman Bin Faisal UniversityCompleted
-
Ankara Yildirim Beyazıt UniversityCompletedPain | Shoulder SyndromeTurkey
-
Hacettepe UniversityCompletedHemiplegia, SpasticTurkey
-
Universidade Federal de Sao CarlosCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.CompletedShoulder Impingement SyndromeBrazil
-
Majmaah UniversityKing Saud UniversityCompletedOsteo Arthritis KneeSaudi Arabia
-
The Hong Kong Polytechnic UniversityActive, not recruiting
-
César Fernández-de-las-PeñasUniversity of SalamancaCompleted
-
CEU San Pablo UniversityCompletedChronic Instability of Joint
-
Riphah International UniversityRecruitingChronic Ankle SprainPakistan