Lateral Ankle SprainNCT01119092
The Effects of Gentle Movements at the Ankle in Individuals With Diminished Range of Motion
A study testing Grade IV AP joint mobilizations in people with Lateral Ankle Sprain, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lateral Ankle Sprain
- What is being tested?
- Grade IV AP joint mobilizations
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to May 2011
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of a lateral ankle sprain within the last year
- Dorsiflexion range of motion deficit of 5°
- Return to full activity prior to participation in this study
- Individuals with dorsiflexion range of motion that is less than degrees of dorsiflexion.
Who cannot join
- A history of ankle surgery that involves intra-articular fixation
- Syndesmotic ankle sprain (to be ruled out based on the attending certified athletic trainers diagnosis)
- A history or signs of reflex sympathetic dystrophy
- Suffer from an acute injury in the lower extremity within the last 6 weeks
- Have received manual therapy for the ankle sprain prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Jay Hertel, PhD, 434-243-8673, jayhertel@aol.com
Nicole Cosby, 951-515-3054, nlb4v@virginia.edu
About this study
Official title: The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain
The purpose of this study is the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion.
Read the detailed description
The purpose of this study is the examine the effects of a grade IV anterior to posterior joint mobilization and stretching on self-reported function, dorsiflexion range of motion, talar glide and stiffness in individuals who have suffered from an ankle sprain within the last year and have a 5° dorsiflexion range of motion deficit.
We will quantify range of motion with standard goniometric measures, stiffness with the use of an instrumented ankle arthrometer, talar glide with the use of the posterior talar glide test and self-reported function using the foot and ankle ability measure (FAAM) and FAAM-sport.
- Conditions
- Lateral Ankle Sprain
- Being tested
- Sham ("laying of hands") intervention, Grade IV AP joint mobilizations
- Keywords
- Ankle Sprain, Joint Mobilization, Manual Therapy, Range of Motion
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham ("laying of hands") interventionOther
The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.
Grade IV AP joint mobilizationsOther
3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.
| Study group | Role | What they receive |
|---|---|---|
| Sham intervention plus standard treatment | Sham comparator | This group will receive a "laying of hands" treatment in addition to standard treatment. The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between. Receives: Other: Sham ("laying of hands") intervention |
| Control Group | No intervention | This group will be individuals who suffer from the same injury but will be instructed to stretch at home 5 days a week for 2 weeks. |
| Grade IV AP joint mobilization plus standard treatment | Experimental | This group will receive 3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment. Receives: Other: Grade IV AP joint mobilizations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dorsiflexion range of motion
Measured: Baseline and 4 weeks
Change in posterior talar glide
Measured: Baseline and 4 weeks
Change in posterior talar translation
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Change in self reported function
Measured: Baseline and 4 weeks
Change in ankle stiffness
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Training Association Research & Education Foundation
- Investigators
- Jay Hertel, PhD, Principal investigator, University to Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119092
- Sponsor's protocol ID
- 14787
- Other IDs
- 14794
- Status last verified
- May 2011
- First submitted
- 5 May 2010
- Last updated
- 30 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Talocrural Joint Mobilizations in Individuals With Diminished Dorsiflexion Range of Motion After Ankle Sprain
- ClinicalTrials.gov ID
- NCT01119092
- Acronym / sponsor ID
- 14787
- Conditions
- Lateral Ankle Sprain
- Keywords
- Ankle Sprain, Joint Mobilization, Manual Therapy, Range of Motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Athletic Training Association Research & Education Foundation
- Study start
- Jan 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 7 May 2010 (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 the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion.
Detailed description
The purpose of this study is the examine the effects of a grade IV anterior to posterior joint mobilization and stretching on self-reported function, dorsiflexion range of motion, talar glide and stiffness in individuals who have suffered from an ankle sprain within the last year and have a 5° dorsiflexion range of motion deficit.
We will quantify range of motion with standard goniometric measures, stiffness with the use of an instrumented ankle arthrometer, talar glide with the use of the posterior talar glide test and self-reported function using the foot and ankle ability measure (FAAM) and FAAM-sport.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham intervention plus standard treatment | Sham comparator | Other: Sham ("laying of hands") interventionThis group will receive a "laying of hands" treatment in addition to standard treatment. The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between. |
| Control Group | No intervention | –This group will be individuals who suffer from the same injury but will be instructed to stretch at home 5 days a week for 2 weeks. |
| Grade IV AP joint mobilization plus standard treatment | Experimental | Other: Grade IV AP joint mobilizationsThis group will receive 3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of a lateral ankle sprain within the last year
- Dorsiflexion range of motion deficit of 5°
- Return to full activity prior to participation in this study
- Individuals with dorsiflexion range of motion that is less than degrees of dorsiflexion.
Key exclusion criteria (5 listed)
- A history of ankle surgery that involves intra-articular fixation
- Syndesmotic ankle sprain (to be ruled out based on the attending certified athletic trainers diagnosis)
- A history or signs of reflex sympathetic dystrophy
- Suffer from an acute injury in the lower extremity within the last 6 weeks
- Have received manual therapy for the ankle sprain prior to enrollment
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 |
|---|---|---|
| Sham ("laying of hands") interventionThe clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between. | Other | Sham intervention plus standard treatment |
| Grade IV AP joint mobilizations3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment. | Other | Grade IV AP joint mobilization plus standard treatment |
Primary outcome
Change in dorsiflexion range of motion
Time frame: Baseline and 4 weeks
Change in posterior talar glide
Time frame: Baseline and 4 weeks
Change in posterior talar translation
Time frame: Baseline and 4 weeks
2 secondary outcomes
Change in self reported function
Time frame: Baseline and 4 weeks
Change in ankle stiffness
Time frame: Baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2011.
Related trials for Lateral Ankle Sprain
Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Not yet recruiting
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
Ankle Sprains, Lateral Ankle Sprain
Recruiting
Mulligan Mobilization With Movement for Acute Lateral Ankle Sprains
Lateral Ankle Sprain
Recruiting
Dynamic Neuromuscular Stability Exercises With and Without Rhythmic Auditory Stimulation in Lateral Ankle Sprain
Ankle Sprain, Lateral Ankle Sprain
RecruitingObservational study
Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
Ankle Sprain, Hypermobility, Joint
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.
Jay Hertel, PhD principal investigator
University to Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grade IV AP joint mobilizations in people with Lateral Ankle Sprain, run by University of Virginia at 1 site in United States.
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 4 inclusion and 5 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 30 May 2011. 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 United States. 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 Nicole Cosby (951-515-3054, nlb4v@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dorsiflexion range of motion (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. 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 30 May 2011.