Ankle SprainsNCT02244008
Accumulative Effects of Talus Mobilization
A study testing joint mobilization and manual contact in people with Ankle Sprains and Ankle Fractures, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The purpose of this study is to verify the effect of anteroposterior talus mobilization on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Ankle Sprains, Ankle Fractures, Ankle Dislocations
- What is being tested?
- joint mobilization and manual contact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Dec 2013
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- unilateral traumatic injury of the ankle with at least two weeks and maximum eight months
- at least a 5º limitation of passive dorsiflexion in comparison to the contralateral side
- do not be under another physical therapy treatment for the lesion
- able to unload partial or total body weight
- do not be in use of analgesic
- provided informed consent after receiving and explanation of all procedures and pertinent information regarding the study
Who cannot join
- joint blockage by surgical fixation or ankylosis
- presence of vascular, rheumatic, neurological and neoplastic disease in the lower limb
- open or contagious lesion in the ankle region
- pain during palpation in the region anterior of the ankle
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Minas Gerais College of Medical Sciences
Belo Horizonte, Minas Gerais, 30130-110
About this study
Official title: Effects of Anteroposterior Talus Mobilization on Range of Motion, Pain, and Functional Capacity in Participants With Sub-acute and Chronic Ankle Injuries: A Randomized Controlled Trial
The purpose of this study is to verify the effect of anteroposterior talus mobilization on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries.
Read the detailed description
The purpose of this study was to verify the acute effect (one session) and chronic (six sessions) and follow-up of the anteroposterior talus mobilization Maitland's grade III on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries. Thirty eight volunteers subjects (male and female) participated of this study with minimum 18 and maximum 59 years old. The volunteers were allocated in two groups: experimental and control. The variables related to range of motion, pain and functional capacity were measured by biplane goniometer, Visual Analog Scale and Foot and Ankle Ability Measure respectively in four moments: 1- baseline; 2- after the first intervention; 3- after the sixth intervention (two weeks); 4- follow-up (one month). The experimental group received anteroposterior articular mobilization of the talus and the control group received manual contact.
- Conditions
- Ankle Sprains, Ankle Fractures, Ankle Dislocations, Ankle Bruises, Achilles Tendon Rupture
- Being tested
- joint mobilization, manual contact
- Keywords
- Mobilization, Joint Range of Motion, Ankle, Manual Therapy
- Medical subject headings
- Ankle Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint mobilizationOther
The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
manual contactOther
The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
| Study group | Role | What they receive |
|---|---|---|
| joint mobilization | Experimental | Anteroposterior mobilization of the talus (Maitland mobilization grade III) Receives: Other: joint mobilization |
| manual contact | Placebo comparator | Not described Receives: Other: manual contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dorsiflexion range of motion
Dorsiflexion range of motion were measured by biplane goniometer.
Measured: 1 month
Secondary outcomes (2)
Changes in pain intensity
Pain were measured by Visual Analog Scale.
Measured: 1 month
Changes in functional capacity
Functional capacity were measured by Foot and Ankle Ability Measure.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAFAEL DUARTE SILVA, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244008
- Sponsor's protocol ID
- RDS3123
- Status last verified
- Sep 2014
- First submitted
- 15 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.
PubMed 22610971Landrum EL, Kelln CB, Parente WR, Ingersoll CD, Hertel J. Immediate Effects of Anterior-to-Posterior Talocrural Joint Mobilization after Prolonged Ankle Immobilization: A Preliminary Study. J Man Manip Ther. 2008;16(2):100-5. doi: 10.1179/106698108790818413.
PubMed 19119395Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
PubMed 23850371Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.
PubMed 20886654Harkey M, McLeod M, Van Scoit A, Terada M, Tevald M, Gribble P, Pietrosimone B. The immediate effects of an anterior-to-posterior talar mobilization on neural excitability, dorsiflexion range of motion, and dynamic balance in patients with chronic ankle instability. J Sport Rehabil. 2014 Nov;23(4):351-9. doi: 10.1123/jsr.2013-0085. Epub 2014 Apr 3.
PubMed 24700526
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anteroposterior Talus Mobilization on Range of Motion, Pain, and Functional Capacity in Participants With Sub-acute and Chronic Ankle Injuries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02244008
- Acronym / sponsor ID
- RDS3123
- Conditions
- Ankle Sprains, Ankle Fractures, Ankle Dislocations, Ankle Bruises, Achilles Tendon Rupture
- Keywords
- Mobilization, Joint Range of Motion, Ankle, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Sep 2014 (estimated)
- 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 purpose of this study is to verify the effect of anteroposterior talus mobilization on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries.
Detailed description
The purpose of this study was to verify the acute effect (one session) and chronic (six sessions) and follow-up of the anteroposterior talus mobilization Maitland's grade III on range of motion, pain, and functional capacity in participants with sub-acute and chronic ankle injuries. Thirty eight volunteers subjects (male and female) participated of this study with minimum 18 and maximum 59 years old. The volunteers were allocated in two groups: experimental and control. The variables related to range of motion, pain and functional capacity were measured by biplane goniometer, Visual Analog Scale and Foot and Ankle Ability Measure respectively in four moments: 1- baseline; 2- after the first intervention; 3- after the sixth intervention (two weeks); 4- follow-up (one month). The experimental group received anteroposterior articular mobilization of the talus and the control group received manual contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| joint mobilization | Experimental | Other: joint mobilizationAnteroposterior mobilization of the talus (Maitland mobilization grade III) |
| manual contact | Placebo comparator | Other: manual contact |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- unilateral traumatic injury of the ankle with at least two weeks and maximum eight months
- at least a 5º limitation of passive dorsiflexion in comparison to the contralateral side
- do not be under another physical therapy treatment for the lesion
- able to unload partial or total body weight
- do not be in use of analgesic
Key exclusion criteria (4 listed)
- joint blockage by surgical fixation or ankylosis
- presence of vascular, rheumatic, neurological and neoplastic disease in the lower limb
- open or contagious lesion in the ankle region
- pain during palpation in the region anterior of the ankle
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 |
|---|---|---|
| joint mobilizationThe experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions. | Other | joint mobilization |
| manual contactThe placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions. | Other | manual contact |
Primary outcome
Changes in dorsiflexion range of motion
Time frame: 1 month
Dorsiflexion range of motion were measured by biplane goniometer.
2 secondary outcomes
Changes in pain intensity
Time frame: 1 month
Changes in functional capacity
Time frame: 1 month
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 18 Sep 2014.
- Results publication: PubMed 22610971Hoch MC, Andreatta RD, Mullineaux DR, English RA, Medina McKeon JM, Mattacola CG, McKeon PO. Two-week joint mobilization intervention improves self-reported function, range of motion, and dynamic balance in those with chronic ankle instability. J Orthop Res. 2012 Nov;30(11):1798-804. doi: 10.1002/jor.22150. Epub 2012 May 18.
- Results publication: PubMed 19119395Landrum EL, Kelln CB, Parente WR, Ingersoll CD, Hertel J. Immediate Effects of Anterior-to-Posterior Talocrural Joint Mobilization after Prolonged Ankle Immobilization: A Preliminary Study. J Man Manip Ther. 2008;16(2):100-5. doi: 10.1179/106698108790818413.
- Results publication: PubMed 23850371Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
- Results publication: PubMed 20886654Hoch MC, McKeon PO. Joint mobilization improves spatiotemporal postural control and range of motion in those with chronic ankle instability. J Orthop Res. 2011 Mar;29(3):326-32. doi: 10.1002/jor.21256. Epub 2010 Sep 30.
- Results publication: PubMed 24700526Harkey M, McLeod M, Van Scoit A, Terada M, Tevald M, Gribble P, Pietrosimone B. The immediate effects of an anterior-to-posterior talar mobilization on neural excitability, dorsiflexion range of motion, and dynamic balance in patients with chronic ankle instability. J Sport Rehabil. 2014 Nov;23(4):351-9. doi: 10.1123/jsr.2013-0085. Epub 2014 Apr 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing joint mobilization and manual contact in people with Ankle Sprains and Ankle Fractures, run by Federal University of Minas Gerais 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 6 inclusion and 4 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 18 Sep 2014. 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?
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?
Changes in dorsiflexion range of motion (time frame: 1 month). 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 NCT02244008, which also lists 5 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 18 Sep 2014.