Ankle Joint ContractureNCT03171233
Immediate Effects of Two Ankle Mobilization Techniques in the Amplitude of Dorsiflexion and Dynamic Valgus Knee
A study testing Mobilization with movement and Self mobilization with movement in people with Ankle Joint Contracture and Knee Injuries and Disorders, run by Universidade Federal do Ceara at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Joint Contracture, Knee Injuries and Disorders
- What is being tested?
- Mobilization with movement and Self mobilization with movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Apr 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Two Ankle Mobilization Techniques in the Amplitude of Dorsiflexion and Dynamic Valgus Knee: a Random Clinical Test
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.
Read the detailed 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."
- Being tested
- Mobilization with movement, Self mobilization with movement
- Medical subject headings
- Knee Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movementOther
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 movementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group mobilization with movement | Active comparator | Techniques to improve ankle mobility that possibily will to cause changes in the biomechanical motion of the lower limb. The patient does the movement actively, but is assisted by the therapist to mobilize. Receives: Other: Mobilization with movement |
| Group Self mobilization with movement | Active comparator | Techniques to improve ankle mobility that possibily will to cause changes in the biomechanical motion of the lower limb. The patient performs the movement and the mobilization in an independently way without receiving help from the therapist Receives: Other: Self mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after intervention
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start5 Apr 2017
- Primary completion30 Oct 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ankle Joint ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
- Investigators
- Gabriel PL Almeida, MsC, Principal investigator, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171233
- Sponsor's protocol ID
- TCC_Fernanda
- Status last verified
- Jun 2024
- First submitted
- 27 May 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almeida GP, Carvalho E Silva AP, Franca FJ, Magalhaes 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.
PubMed 26118529Amraee 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.
PubMed 26704803Barton 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). 2012 Aug;27(7):702-5. doi: 10.1016/j.clinbiomech.2012.02.007. Epub 2012 Mar 20.
PubMed 22436492Bell 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.
PubMed 23724771Bennell 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. doi: 10.1016/s0004-9514(14)60377-9.
PubMed 11676731Bittencourt NF, Ocarino JM, Mendonca 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.
PubMed 22990391Collins 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. doi: 10.1016/S1356-689X(03)00101-2.
PubMed 15040966Cronstrom 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. doi: 10.1007/s40279-016-0519-8.
PubMed 27048463Dill 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.
PubMed 25144599Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.
PubMed 11440498Fong 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.
PubMed 21214345Hoch MC, McKeon PO. The effectiveness of mobilization with movement at improving dorsiflexion after ankle sprain. J Sport Rehabil. 2010 May;19(2):226-32. doi: 10.1123/jsr.19.2.226.
PubMed 20543222Jeon 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.
PubMed 26633750Loudon 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.
PubMed 12937582Malliaras 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. doi: 10.1016/j.jsams.2006.03.015. Epub 2006 May 2.
PubMed 16672192
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Two Ankle Mobilization Techniques in the Amplitude of Dorsiflexion and Dynamic Valgus Knee: a Random Clinical Test
- ClinicalTrials.gov ID
- NCT03171233
- Acronym / sponsor ID
- TCC_Fernanda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group mobilization with movement | Active comparator | Other: Mobilization with movementTechniques to improve ankle mobility that possibily will to cause changes in the biomechanical motion of the lower limb. The patient does the movement actively, but is assisted by the therapist to mobilize. |
| Group Self mobilization with movement | Active comparator | Other: Self mobilization with movementTechniques to improve ankle mobility that possibily will to cause changes in the biomechanical motion of the lower limb. The patient performs the movement and the mobilization in an independently way without receiving help from the therapist |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization with movementParticipants 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. | Other | Group mobilization with movement |
| Self mobilization with movementIn 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. | Other | Group Self mobilization with movement |
Primary outcome
Range of motion of ankle dorsiflexion Range of motion of ankle dorsiflexion
Time frame: Immediately after intervention
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations
Angle of projection in the frontal plane.
Time frame: Immediately after intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 26118529Almeida GP, Carvalho E Silva AP, Franca FJ, Magalhaes 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.
- Background: PubMed 26704803Amraee 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.
- Background: PubMed 22436492Barton 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). 2012 Aug;27(7):702-5. doi: 10.1016/j.clinbiomech.2012.02.007. Epub 2012 Mar 20.
- Background: PubMed 23724771Bell 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.
- Background: PubMed 11676731Bennell 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. doi: 10.1016/s0004-9514(14)60377-9.
- Background: PubMed 22990391Bittencourt NF, Ocarino JM, Mendonca 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.
- Background: PubMed 15040966Collins 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. doi: 10.1016/S1356-689X(03)00101-2.
- Background: PubMed 27048463Cronstrom 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. doi: 10.1007/s40279-016-0519-8.
- Background: PubMed 25144599Dill 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.
- Background: PubMed 11440498Exelby L. Peripheral mobilisations with movement. Man Ther. 1996 Jun;1(3):118-126. doi: 10.1054/math.1996.0259.
- Background: PubMed 21214345Fong 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.
- Background: PubMed 20543222Hoch MC, McKeon PO. The effectiveness of mobilization with movement at improving dorsiflexion after ankle sprain. J Sport Rehabil. 2010 May;19(2):226-32. doi: 10.1123/jsr.19.2.226.
- Individual participant dataSharing planned: No
Related trials for Ankle Joint Contracture
Not yet recruiting
Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients
Ankle Contracture, Critically Ill Intensive Care Unit Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel PL Almeida, MsC principal investigator
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization with movement and Self mobilization with movement in people with Ankle Joint Contracture and Knee Injuries and Disorders, run by Universidade Federal do Ceara at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of ankle dorsiflexion Range of motion of ankle dorsiflexion (time frame: Immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171233, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.