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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03171233
Other study ID # TCC_Fernanda
Secondary ID
Status Recruiting
Phase N/A
First received May 27, 2017
Last updated May 27, 2017
Start date April 5, 2017
Est. completion date December 1, 2017

Study information

Verified date May 2017
Source Universidade Federal do Ceara
Contact Gabriel PL Almeida, MsC
Phone 5585999590400
Email GABRIEL_ALM@HOTMAIL.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dynamic knee valgus is an inadequate biomechanical movement of multifactorial cause that may expose the individual to various injuries. The range of motion of ankle dorsiflexion is one of the possible influencing factors. This study intends to compare the immediate effect of two techniques on ankle mobility and dynamic knee valgus.


Description:

This study aims to verify the immediate effects of ankle mobilization on dynamic knee valgus and to compare two techniques of ankle mobility. It will include 102 lower limbs that present deficit of ankle dorsiflexion and dynamic knee valgus in the same lower limb.

Participants will be divided into two groups, one for ankle mobilization with movement aided by the therapist and another for self mobilization of the ankle. The two intervention groups will do the same protocol, same number of sets, repetitions and rest time.There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.

The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date December 1, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Physically active individuals (30 minutes of moderate physical activity at least three times a week with at least 6 months of practice); Men or women ranging in age from 18 to 35 years; (With a value equal to or less than 10 cm in the measuring tape and / or 2 cm difference between the limbs) and dynamic knee valgus (center of the patella surpassing the midpoint between the malleoles ) evaluated by Forward Step Down Test (FSDT).

Exclusion Criteria:

- Patients who present any of these conditions will be excluded from the study: chronic ankle instability, previous surgery on the joints of the foot, ankle, knee, hip or ankle joint injury in the last 2 years that caused more than 1 month of withdrawal; Recent muscular or skeletal injuries that do not allow the exercises to be performed; Severe cardiac conditions or other pathological conditions that make physical therapy impossible.

Study Design


Intervention

Other:
Mobilization with movement
Participants Mobilization Group with Movement are positioned knee facing the physiotherapist, are not elastic passages above the participant's malleolus and are from the physiotherapist's pelvis. The therapist applies a posterolateral slip sustained to a tibia through the belt, leaning backward, while the talus and forefoot are secured with the space between the thumb and the second finger of the hand of both hands. The participant will be instructed to perform a slow dorsiflexion movement for their maximum amplitude.
Self mobilization with movement
In the Auto Mobilization with Movement group, participants will self-mobilize the ankle on top of a box (15 centimeters with a 10 ° incline), a non-elastic band will pass below the malleoli and the back of the band will be placed in the middle of the other Lower limb, thus mobilizing the talus in the posteroinferior direction, the participant should maintain the force in that direction while making the dorsiflexion movement in closed kinetic chain until returning to the initial position again. Using the same group protocol as the therapist will help.

Locations

Country Name City State
Brazil Federal University of Ceara Fortaleza Ceará

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

References & Publications (15)

Almeida GP, Carvalho E Silva AP, França FJ, Magalhães MO, Burke TN, Marques AP. Does anterior knee pain severity and function relate to the frontal plane projection angle and trunk and hip strength in women with patellofemoral pain? J Bodyw Mov Ther. 2015 Jul;19(3):558-64. doi: 10.1016/j.jbmt.2015.01.004. Epub 2015 Jan 26. — View Citation

Amraee D, Alizadeh MH, Minoonejhad H, Razi M, Amraee GH. Predictor factors for lower extremity malalignment and non-contact anterior cruciate ligament injuries in male athletes. Knee Surg Sports Traumatol Arthrosc. 2017 May;25(5):1625-1631. doi: 10.1007/s00167-015-3926-8. Epub 2015 Dec 24. — View Citation

Barton CJ, Levinger P, Crossley KM, Webster KE, Menz HB. The relationship between rearfoot, tibial and hip kinematics in individuals with patellofemoral pain syndrome. Clin Biomech (Bristol, Avon). 2012 Aug;27(7):702-5. doi: 10.1016/j.clinbiomech.2012.02.007. Epub 2012 Mar 20. — View Citation

Bell DR, Oates DC, Clark MA, Padua DA. Two- and 3-dimensional knee valgus are reduced after an exercise intervention in young adults with demonstrable valgus during squatting. J Athl Train. 2013 Jul-Aug;48(4):442-9. doi: 10.4085/1062-6050-48.3.16. Epub 2013 May 31. — View Citation

Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. — View Citation

Bittencourt NF, Ocarino JM, Mendonça LD, Hewett TE, Fonseca ST. Foot and hip contributions to high frontal plane knee projection angle in athletes: a classification and regression tree approach. J Orthop Sports Phys Ther. 2012 Dec;42(12):996-1004. doi: 10.2519/jospt.2012.4041. Epub 2012 Sep 18. — View Citation

Collins N, Teys P, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains. Man Ther. 2004 May;9(2):77-82. — View Citation

Cronström A, Creaby MW, Nae J, Ageberg E. Modifiable Factors Associated with Knee Abduction During Weight-Bearing Activities: A Systematic Review and Meta-Analysis. Sports Med. 2016 Nov;46(11):1647-1662. Review. — View Citation

Dill KE, Begalle RL, Frank BS, Zinder SM, Padua DA. Altered knee and ankle kinematics during squatting in those with limited weight-bearing-lunge ankle-dorsiflexion range of motion. J Athl Train. 2014 Nov-Dec;49(6):723-32. doi: 10.4085/1062-6050-49.3.29. — View Citation

Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. — View Citation

Fong CM, Blackburn JT, Norcross MF, McGrath M, Padua DA. Ankle-dorsiflexion range of motion and landing biomechanics. J Athl Train. 2011 Jan-Feb;46(1):5-10. doi: 10.4085/1062-6050-46.1.5. — View Citation

Hoch MC, McKeon PO. The effectiveness of mobilization with movement at improving dorsiflexion after ankle sprain. J Sport Rehabil. 2010 May;19(2):226-32. Review. — View Citation

Jeon IC, Kwon OY, Yi CH, Cynn HS, Hwang UJ. Ankle-Dorsiflexion Range of Motion After Ankle Self-Stretching Using a Strap. J Athl Train. 2015 Dec;50(12):1226-32. doi: 10.4085/1062-6050-51.1.01. Epub 2015 Dec 3. — View Citation

Loudon JK, Wiesner D, Goist-Foley HL, Asjes C, Loudon KL. Intrarater Reliability of Functional Performance Tests for Subjects With Patellofemoral Pain Syndrome. J Athl Train. 2002 Sep;37(3):256-261. — View Citation

Malliaras P, Cook JL, Kent P. Reduced ankle dorsiflexion range may increase the risk of patellar tendon injury among volleyball players. J Sci Med Sport. 2006 Aug;9(4):304-9. Epub 2006 May 2. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion of ankle dorsiflexion Range of motion of ankle dorsiflexion Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations Immediately after intervention
Primary Angle of projection in the frontal plane. 190/5000 Will be measured during the conduct of the Forward Step-Down Test through 2D-captured footage using a digital camera that will be positioned within 2 meters of the step. Immediately after intervention
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