Ankle SprainsNCT03079804
Comparison Between Two Mobilization Techniques of Ankle on Balance in Patients With Chronic Ankle Instability
A study testing Experimental MWM and Experimental Thrust in people with Ankle Sprains, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Experimental MWM and Experimental Thrust
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2017to 31 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants with acute or subacute lesions and / or lower limb surgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Ceará
Fortaleza, Ceará, 60416130
Pedro O Lima, Professor, 5585988643219 ext. 55, pedrofisioterapia@hotmail.com
Laísa B Maia, Student, 5585986786898 ext. 55, fisiolaisa@gmail.com
About this study
Official title: Comparison Between Two Mobilization Techniques With and Without Ankle Thrust on Balance in Patients With Chronic Ankle Instability
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.
Read the 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.
- Conditions
- Ankle Sprains
- Being tested
- Experimental MWM, Experimental Thrust, Placebo
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental MWMOther
Mobilization with Movement
Experimental ThrustOther
Mobilization grade 5 (Thrust)
PlaceboOther
Procedures similar to Experimental MWM group, but without aplly any force
| Study group | Role | What they receive |
|---|---|---|
| Experimental MWM | Experimental | Other names:
4 mobilizations - 10 seconds 20 seconds of rest Receives: Other: Experimental MWM; Other: Experimental Thrust; Other: Placebo |
| Experimental Thrust | Active comparator | Other names:
1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion. Receives: Other: Experimental MWM; Other: Experimental Thrust; Other: Placebo |
| Placebo | Placebo comparator | 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. Receives: Other: Experimental MWM; Other: Experimental Thrust; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance assessed with Biodex Balance System
Balance assessed with Biodex Balance System (stabilometry plattaform)
Measured: almost 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start30 Jan 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Olavo de Paula Lima, Universidade Federal do Ceara
- Investigators
- Pedro Lima, PhD, Principal investigator, UFC - DEFISIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079804
- Sponsor's protocol ID
- POdePLima
- Status last verified
- Oct 2017
- First submitted
- 6 Mar 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Mobilization Techniques With and Without Ankle Thrust on Balance in Patients With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03079804
- Acronym / sponsor ID
- POdePLima
- Conditions
- Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 14 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental MWM | Experimental | Other: Experimental MWM, Other: Experimental Thrust, Other: PlaceboOther names: 4 mobilizations - 10 seconds 20 seconds of rest |
| Experimental Thrust | Active comparator | Other: Experimental MWM, Other: Experimental Thrust, Other: PlaceboOther names: 1 traction with caudal direction in high speed and low amplitude increasing dorsiflexion. |
| Placebo | Placebo comparator | Other: Experimental MWM, Other: Experimental Thrust, Other: PlaceboOther 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants with acute or subacute lesions and / or lower limb surgery.
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 |
|---|---|---|
| Experimental MWMMobilization with Movement | Other | Experimental MWM, Experimental Thrust, Placebo |
| Experimental ThrustMobilization grade 5 (Thrust) | Other | Experimental MWM, Experimental Thrust, Placebo |
| PlaceboProcedures similar to Experimental MWM group, but without aplly any force | Other | Experimental MWM, Experimental Thrust, Placebo |
Primary outcome
Balance assessed with Biodex Balance System
Time frame: almost 10 minutes
Balance assessed with Biodex Balance System (stabilometry plattaform)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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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.
Pedro Lima, PhD principal investigator
UFC - DEFISIO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental MWM and Experimental Thrust in people with Ankle Sprains, 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Lima, PhD (5585988643219, pedrolima@ufc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance assessed with Biodex Balance System (time frame: almost 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2017.