- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01117909
Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
May 26, 2011 updated by: University of Virginia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
-
Contact:
- Terry Grindstaff, PhD, DPT
- Phone Number: 434-243-2430
- Email: tlg6q@virginia.edu
-
Contact:
- Nicole Cosby, MS, ATC
- Phone Number: 434-924-6184
- Email: nlb4v@virginia.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: "Laying of hands" plus standard therapy
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
|
Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
|
Experimental: Standard therapy with joint mobilization
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and four weeks
|
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.
|
Baseline and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ankle dorsiflexion range of motion
Time Frame: Baseline and 4 weeks
|
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.
|
Baseline and 4 weeks
|
Change in ligamentous laxity
Time Frame: Baseline and 4 weeks
|
We hypothesize that ligamentous laxity in both groups will be reduced.
|
Baseline and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Terry Grindstaff, PhD, DPT, University of Virginia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
May 4, 2010
First Submitted That Met QC Criteria
May 5, 2010
First Posted (Estimate)
May 6, 2010
Study Record Updates
Last Update Posted (Estimate)
May 30, 2011
Last Update Submitted That Met QC Criteria
May 26, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14919
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankle Sprain
-
Decathlon SEEFOR, FranceTerminatedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeFrance
-
Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
-
National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
-
Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
-
Vanderbilt University Medical CenterRecruitingMusculoskeletal Injury | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeUnited States
-
University of VirginiaNational Athletic Training Association Research & Education FoundationUnknownLateral Ankle SprainUnited States
-
Hospital Universitario Infanta LeonorCompletedMild Ankle SprainSpain
-
University Hospital, GrenobleCompleted
-
Université Catholique de LouvainUZ Leuven, campus Pellenberg (Belgium)RecruitingChronic Ankle Instability | Lateral Ankle SprainBelgium
Clinical Trials on Sham intervention
-
University of BernUniversity of Zurich; Swiss National Science Foundation; University of Basel; Utrecht...CompletedMultimorbidity | PolypharmacySwitzerland
-
PD. Dr. med. Carola SeifartGerman Federal Ministry of Education and Research; Philipps University Marburg... and other collaboratorsUnknownNeoplasms | Advanced Cancer | End Stage CancerGermany
-
Herlev and Gentofte HospitalUnknownCoronary Heart Disease | Ischemic Heart Disease | Stable AnginaDenmark
-
University of Sao Paulo General HospitalEnrolling by invitationCompulsive Sexual BehaviorBrazil
-
Laval UniversitySaey, Didier, M.D.; Oueslati, Ferid, PhDUnknownPulmonary Disease, Chronic ObstructiveCanada
-
University of FloridaCompletedSensitivityUnited States
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Chung Shan Medical UniversityCompleted
-
University of MelbourneMonash University; Western Sydney Local Health District; Royal Prince Alfred... and other collaboratorsRecruitingMotor Neuron Disease / Amyotrophic Lateral SclerosisAustralia