Ankle SprainNCT01117909
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
A study testing Mobilization therapy in addition to standard therapy in people with Ankle Sprain, run by University of Virginia at 1 site in United States.
Trial summary
The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Mobilization therapy in addition to standard therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 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
- Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
- Slight reduction in function
- Anterolateral ankle tenderness
- Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
- Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
- Posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10
- Suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days
Who cannot join
- A history of ankle surgery that involves intra-articular fixation,
- Syndesmotic ankle sprain (to be ruled out based on clinical examination),
- History or signs of reflex sympathetic dystrophy,
- Have received manual therapy for the ankle sprain prior to enrollment
- Grade III ankle sprain.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Terry Grindstaff, PhD, DPT, 434-243-2430, tlg6q@virginia.edu
Nicole Cosby, MS, ATC, 434-924-6184, nlb4v@virginia.edu
About this study
The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.
Read the detailed description
The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.
- Conditions
- Ankle Sprain
- Being tested
- Mobilization therapy in addition to standard therapy, Sham intervention
- Keywords
- ankle sprain, athletic injury, arthritis
- Medical subject headings
- Ankle Injuries, Athletic Injuries, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization therapy in addition to standard therapyOther
Subject will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression.
Sham interventionOther
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
| Study group | Role | What they receive |
|---|---|---|
| "Laying of hands" plus standard therapy | Sham comparator | Subjects will lie on their back as if they were receiving the joint mobilization treatment and the therapist will place their hands in a position as if to perform the mobilization but no movement will occur. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression Receives: Other: Sham intervention |
| Standard therapy with joint mobilization | Experimental | This group will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session, in addition to standard therapy. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression Receives: Other: Mobilization therapy in addition to standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported function
We hypothesize that the group that receives joint mobilization in addition to standard therapy will show greater improvements in Functional Ankle and Ability Measure (FAAM) and FAAM-Sport (FAAM-S) scores than those who receive standard therapy alone.
Measured: Baseline and four weeks
Change in self-reported pain
We hypothesize visual analog scale (VAS) scores for pain will have a greater improvement in those who received joint mobilization in addition to standard therapy when compared to standard therapy alone.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Change in ankle dorsiflexion range of motion
We hypothesize that mobilization when applied to the talocrural joint in addition to standard therapy will result in a greater increase of ankle dorsiflexion ROM than just standard therapy alone.
Measured: Baseline and 4 weeks
Change in ligamentous laxity
We hypothesize that ligamentous laxity in both groups will be reduced.
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 posted6 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American Physical Therapy Association
- Investigators
- Terry Grindstaff, PhD, DPT, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117909
- Sponsor's protocol ID
- 14919
- Status last verified
- May 2011
- First submitted
- 4 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
- Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
- ClinicalTrials.gov ID
- NCT01117909
- Acronym / sponsor ID
- 14919
- Conditions
- Ankle Sprain
- Keywords
- ankle sprain, athletic injury, arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American Physical Therapy Association
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 6 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 goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.
Detailed description
The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Laying of hands" plus standard therapy | Sham comparator | Other: Sham interventionSubjects will lie on their back as if they were receiving the joint mobilization treatment and the therapist will place their hands in a position as if to perform the mobilization but no movement will occur. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression |
| Standard therapy with joint mobilization | Experimental | Other: Mobilization therapy in addition to standard therapyThis group will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session, in addition to standard therapy. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
- Slight reduction in function
- Anterolateral ankle tenderness
- Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
- Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
Key exclusion criteria (5 listed)
- A history of ankle surgery that involves intra-articular fixation,
- Syndesmotic ankle sprain (to be ruled out based on clinical examination),
- History or signs of reflex sympathetic dystrophy,
- Have received manual therapy for the ankle sprain prior to enrollment
- Grade III ankle sprain.
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 therapy in addition to standard therapySubject will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression. | Other | Standard therapy with joint mobilization |
| Sham interventionPhysical therapist will lay hands as if to perform the joint mobilization but no movement will occur. | Other | "Laying of hands" plus standard therapy |
Primary outcome
Change in self-reported function
Time frame: Baseline and four weeks
We hypothesize that the group that receives joint mobilization in addition to standard therapy will show greater improvements in Functional Ankle and Ability Measure (FAAM) and FAAM-Sport (FAAM-S) scores than those who receive standard therapy alone.
Change in self-reported pain
Time frame: Baseline and 4 weeks
We hypothesize visual analog scale (VAS) scores for pain will have a greater improvement in those who received joint mobilization in addition to standard therapy when compared to standard therapy alone.
2 secondary outcomes
Change in ankle dorsiflexion range of motion
Time frame: Baseline and 4 weeks
Change in ligamentous laxity
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.
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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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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.
Terry Grindstaff, PhD, DPT principal investigator
University of 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 Mobilization therapy in addition to standard therapy in people with 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 7 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported function (time frame: Baseline and four weeks). 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?
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.