Injuries, AnkleNCT02697461
Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability
A study testing Intrinsic Foot Strengthening and Joint Mobilization in people with Injuries, Ankle and Sprain of Foot, run by University of Virginia at 1 site in United States.
Trial summary
Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal injuries that are a result of inversion injury during sport. The midfoot is frequently involved during inversion injury, is often overlooked during clinical examination, and maybe contributory to the development of CAI. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries, Ankle, Sprain of Foot
- What is being tested?
- Intrinsic Foot Strengthening and Joint Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jun 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Aged 18-50
- All subjects will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
- All subjects will have no history of ankle injury.
- LAS participants
- Aged 18-50
Show all 12Show fewer
- All subjects with a history of ankle sprains, no lingering symptoms or disability, not actively receiving treatment for their ankle sprain
- All subjects will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
- CAI participants
- Aged 18-50
- CAI with a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. They will have lingering symptoms, and disability, but not actively receiving treatment for their CAI
- All subjects will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
Who cannot join
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for LAS/CAI
- History of prior ankle surgery
- History of ankle or foot fracture
- Diabetes mellitus
- Current self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function
Show all 10Show fewer
- Lumbosacral radiculopathy
- Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome
- Absolute contraindications to manual therapy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Sports Injury Laboratory, University of Virginia
Charlottesville, Virginia, 22908
About this study
Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal injuries that are a result of inversion injury during sport. The midfoot is frequently involved during inversion injury, is often overlooked during clinical examination, and maybe contributory to the development of CAI. The purpose of this study is to investigate multisegmented foot motion using a motion capture system, clinical joint physiological and accessory motion, and morphologic foot measurements in recreationally active men and women with and without a history of lateral ankle sprains and chronic ankle instability. Additionally, the effects of a joint mobilization intervention in patients with diminished multisegmented foot motion and intrinsic foot strengthening in healthy individuals will be investigated.
Read the detailed description
Arm 1:The purpose of this arm of the study is to determine if foot muscle exercises change the function of the foot. Up to 25 people will be enrolled in this arm of the study at the University of Virginia.
Arm 2: The purpose of this arm of the study is to determine if joint mobilization applied to the middle part of the foot will effect function in people who are healthy, have a history of lateral ankle sprains (LAS), or have chronic ankle instability (CAI) and have joint stiffness. Up to 125 people will be enrolled in this arm of the study at the University of Virginia. CAI is a condition where symptoms from an ankle sprain last longer than one year. These symptoms include a feeling of looseness, feelings that the participant may roll the ankle, or repeated ankle sprains. This study may help clinicians prescribe simple exercises at home to help treat CAI. The participants are being asked to be in this study, because they are physically active (participate in some form of physical activity for at least 20 minutes per day, three days per week) and are not currently seeking medical treatment/therapy for LAS/CAI. Joint mobilization is a commonly used clinical intervention used to decrease pain and increase joint range of motion. The home exercises employed for this study are commonly used clinically in the treatment of foot and ankle problems and include a foot and calf stretch and standing on one foot for 60 seconds. The participant will be asked to perform these exercises three times daily throughout the course of the day.
The investigators hypothesize that joint mobilization will improve patient oriented outcomes and measures of joint mobility and excursion in individuals with impaired foot mobility immediately post intervention and at 1-week follow-up, but not at 4 weeks; and intrinsic foot strengthening will result in differences in morphologic measures and intrinsic muscle cross-section in healthy individuals following a 4 week home exercise program.
- Conditions
- Injuries, Ankle, Sprain of Foot
- Being tested
- Intrinsic Foot Strengthening, Joint Mobilization
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic Foot StrengtheningOther
Intrinsic foot strengthening is a commonly used intervention in clinic used to increase foot stability both in prevention of and in treatment of foot and ankle injury. Subjects allocated to the strengthening program will be educated in commonly used short foot exercises and "toe yoga" maneuvers that target the intrinsic muscles of the foot. No equipment will be required to perform the exercises.
Joint MobilizationOther
Joint mobilization is a commonly used clinical intervention used to decrease pain and increase joint range of motion. In the treatment groups who present with joint hypomobility, a forefoot inversion maneuver with a dorsally applied pressure in the lateral midfoot and rearfoot stabilized will be applied at the barrier before the physiologic end range of motion. A second mobilization will be performed at the distal segment of the 1st Tarsometatarsal joint. These mobilizations will be performed by a board certified orthopaedic physical therapist with 14-yrs of practice experience. No equipment will be required to perform the joint mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Intrinsic Foot Arm | Experimental | In arm 1, a randomized control trial will be used in the investigation of validity and reliability comparing multisegmented foot motion, clinical joint physiological and accessory motion, and morphologic foot measurements, and the effect of intrinsic foot strengthening on multisegmented foot function. Receives: Other: Intrinsic Foot Strengthening |
| Joint Mobilization Arm | Experimental | In arm 2, the investigation of group differences in clinical and laboratory measures of multisegmented foot motion and kinetics will use a case control design. A randomized controlled trial will be conducted in the study investigating joint mobilization, with the researcher performing the assessments and the provider performing the treatments blinded to group allocation Receives: Other: Joint Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in midfoot frontal plane range of motion during stance phase of gait.
Segmental motion will be assessed using motion capture and measured in degrees.
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in ultrasound thickness measures of the abductor hallucis
Muscle thickness measures will be measured in cm.
Measured: Arm 1: Baseline, 4 wks.
Foot and Ankle Ability Measure (FAAM)
Patient Report Outcome of Foot and Ankle Function
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in ultrasound thickness measures of the flexor digitorum brevis
Muscle thickness measures will be measured in cm.
Measured: Arm 1: Baseline, 4 wks.
Changes in thickness measures of the flexor hallucis brevis
Muscle thickness measures will be measured in cm.
Measured: Arm 1: Baseline, 4 wks.
Secondary outcomes (16)
Changes in Foot morphological measurements across loading conditions
Measurement of foot length, truncated foot length, foot width, and arch height in cm.
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of forefoot frontal plane range of motion
Measured with an inclinometer in degrees.
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of range of motion of first ray flexion/extension
Measured with a goniometer in degrees.
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of joint laxity of the forefoot
Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of joint laxity of the first ray
Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of toe flexor strength
Assessed using a handheld dynamometer in N
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle inversion strength
Assessed using a handheld dynamometer in N
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle eversion strength
Assessed using a handheld dynamometer in N
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle dorsiflexion strength
Assessed using a handheld dynamometer in N
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle plantarflexion strength
Assessed using a handheld dynamometer in N
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Star excursion balance test
Clinical test of single limb reach/balance in the anterior, posterior lateral, and posterior medial directions in cm.
Measured: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
12-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)
Patient Report Outcome of Function
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Visual Analogue Scale (VAS)
Patient Report Outcome of Pain
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Godin leisure questionnaire
Patient Report Outcome of Physical Activity
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
11-item Tampa Scale of Kinesiophobia (TSK-11)
Patient Report Outcome of Kinesiophobia
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Global Rate of Change (GROC)
Patient Report Outcome of Change in Symptoms
Measured: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startJan 2016
- Primary completion9 May 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Injuries, AnkleStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hertel, PhD, ATC, University of Virginia
- Investigators
- Jay Hertel, PhD, ATC, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697461
- Sponsor's protocol ID
- 18550
- Status last verified
- May 2017
- First submitted
- 11 Jan 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
PubMed 20926721Feger MA, Herb CC, Fraser JJ, Glaviano N, Hertel J. Supervised rehabilitation versus home exercise in the treatment of acute ankle sprains: a systematic review. Clin Sports Med. 2015 Apr;34(2):329-46. doi: 10.1016/j.csm.2014.12.001. Epub 2015 Feb 14.
PubMed 25818717Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CW, Hiller CE. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010 Nov;42(11):2106-21. doi: 10.1249/MSS.0b013e3181de7a8a.
PubMed 20351590Gerber JP, Williams GN, Scoville CR, Arciero RA, Taylor DC. Persistent disability associated with ankle sprains: a prospective examination of an athletic population. Foot Ankle Int. 1998 Oct;19(10):653-60. doi: 10.1177/107110079801901002.
PubMed 9801078Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8. doi: 10.1001/archfami.8.2.143.
PubMed 10101985Konradsen L, Bech L, Ehrenbjerg M, Nickelsen T. Seven years follow-up after ankle inversion trauma. Scand J Med Sci Sports. 2002 Jun;12(3):129-35. doi: 10.1034/j.1600-0838.2002.02104.x.
PubMed 12135444Tanen L, Docherty CL, Van Der Pol B, Simon J, Schrader J. Prevalence of chronic ankle instability in high school and division I athletes. Foot Ankle Spec. 2014 Feb;7(1):37-44. doi: 10.1177/1938640013509670. Epub 2013 Nov 27.
PubMed 24287210Mok KM, Fong DT, Krosshaug T, Engebretsen L, Hung AS, Yung PS, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: 2 cases during the 2008 Beijing Olympics. Am J Sports Med. 2011 Jul;39(7):1548-52. doi: 10.1177/0363546511399384. Epub 2011 Apr 1. No abstract available.
PubMed 21460069Kristianslund E, Bahr R, Krosshaug T. Kinematics and kinetics of an accidental lateral ankle sprain. J Biomech. 2011 Sep 23;44(14):2576-8. doi: 10.1016/j.jbiomech.2011.07.014. Epub 2011 Aug 6.
PubMed 21824618Willems T, Witvrouw E, Delbaere K, De Cock A, De Clercq D. Relationship between gait biomechanics and inversion sprains: a prospective study of risk factors. Gait Posture. 2005 Jun;21(4):379-87. doi: 10.1016/j.gaitpost.2004.04.002.
PubMed 15886127Fong DT, Ha SC, Mok KM, Chan CW, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: five cases from televised tennis competitions. Am J Sports Med. 2012 Nov;40(11):2627-32. doi: 10.1177/0363546512458259. Epub 2012 Sep 11.
PubMed 22967824Fong DT, Chan YY, Mok KM, Yung PS, Chan KM. Understanding acute ankle ligamentous sprain injury in sports. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jul 30;1:14. doi: 10.1186/1758-2555-1-14.
PubMed 19640309Wei F, Fong DT, Chan KM, Haut RC. Estimation of ligament strains and joint moments in the ankle during a supination sprain injury. Comput Methods Biomech Biomed Engin. 2015;18(3):243-8. doi: 10.1080/10255842.2013.792809. Epub 2013 May 8.
PubMed 23654290Bonnel F, Toullec E, Mabit C, Tourne Y; Sofcot. Chronic ankle instability: biomechanics and pathomechanics of ligaments injury and associated lesions. Orthop Traumatol Surg Res. 2010 Jun;96(4):424-32. doi: 10.1016/j.otsr.2010.04.003. Epub 2010 May 20.
PubMed 20493797Blakeslee TJ, Morris JL. Cuboid syndrome and the significance of midtarsal joint stability. J Am Podiatr Med Assoc. 1987 Dec;77(12):638-42. doi: 10.7547/87507315-77-12-638. No abstract available.
PubMed 3430355
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT02697461
- Acronym / sponsor ID
- 18550
- Conditions
- Injuries, Ankle, Sprain of Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 9 May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 3 Mar 2016 (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.
Lateral ankle sprains (LAS) and chronic ankle instability (CAI) are common musculoskeletal injuries that are a result of inversion injury during sport. The midfoot is frequently involved during inversion injury, is often overlooked during clinical examination, and maybe contributory to the development of CAI. The purpose of this study is to investigate multisegmented foot motion using a motion capture system, clinical joint physiological and accessory motion, and morphologic foot measurements in recreationally active men and women with and without a history of lateral ankle sprains and chronic ankle instability. Additionally, the effects of a joint mobilization intervention in patients with diminished multisegmented foot motion and intrinsic foot strengthening in healthy individuals will be investigated.
Detailed description
Arm 1:The purpose of this arm of the study is to determine if foot muscle exercises change the function of the foot. Up to 25 people will be enrolled in this arm of the study at the University of Virginia.
Arm 2: The purpose of this arm of the study is to determine if joint mobilization applied to the middle part of the foot will effect function in people who are healthy, have a history of lateral ankle sprains (LAS), or have chronic ankle instability (CAI) and have joint stiffness. Up to 125 people will be enrolled in this arm of the study at the University of Virginia. CAI is a condition where symptoms from an ankle sprain last longer than one year. These symptoms include a feeling of looseness, feelings that the participant may roll the ankle, or repeated ankle sprains. This study may help clinicians prescribe simple exercises at home to help treat CAI. The participants are being asked to be in this study, because they are physically active (participate in some form of physical activity for at least 20 minutes per day, three days per week) and are not currently seeking medical treatment/therapy for LAS/CAI. Joint mobilization is a commonly used clinical intervention used to decrease pain and increase joint range of motion. The home exercises employed for this study are commonly used clinically in the treatment of foot and ankle problems and include a foot and calf stretch and standing on one foot for 60 seconds. The participant will be asked to perform these exercises three times daily throughout the course of the day.
The investigators hypothesize that joint mobilization will improve patient oriented outcomes and measures of joint mobility and excursion in individuals with impaired foot mobility immediately post intervention and at 1-week follow-up, but not at 4 weeks; and intrinsic foot strengthening will result in differences in morphologic measures and intrinsic muscle cross-section in healthy individuals following a 4 week home exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrinsic Foot Arm | Experimental | Other: Intrinsic Foot StrengtheningIn arm 1, a randomized control trial will be used in the investigation of validity and reliability comparing multisegmented foot motion, clinical joint physiological and accessory motion, and morphologic foot measurements, and the effect of intrinsic foot strengthening on multisegmented foot function. |
| Joint Mobilization Arm | Experimental | Other: Joint MobilizationIn arm 2, the investigation of group differences in clinical and laboratory measures of multisegmented foot motion and kinetics will use a case control design. A randomized controlled trial will be conducted in the study investigating joint mobilization, with the researcher performing the assessments and the provider performing the treatments blinded to group allocation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy participants
- Aged 18-50
- All subjects will be physically active: Participating in some form of physical activity for at least 20 min per day, three times per week.
- All subjects will have no history of ankle injury.
- LAS participants
Key exclusion criteria (10 listed)
- Neurological or vestibular disorders affecting balance
- Currently seeking medical care for LAS/CAI
- History of prior ankle surgery
- History of ankle or foot fracture
- Diabetes mellitus
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 |
|---|---|---|
| Intrinsic Foot StrengtheningIntrinsic foot strengthening is a commonly used intervention in clinic used to increase foot stability both in prevention of and in treatment of foot and ankle injury. Subjects allocated to the strengthening program will be educated in commonly used short foot exercises and "toe yoga" maneuvers that target the intrinsic muscles of the foot. No equipment will be required to perform the exercises. | Other | Intrinsic Foot Arm |
| Joint MobilizationJoint mobilization is a commonly used clinical intervention used to decrease pain and increase joint range of motion. In the treatment groups who present with joint hypomobility, a forefoot inversion maneuver with a dorsally applied pressure in the lateral midfoot and rearfoot stabilized will be applied at the barrier before the physiologic end range of motion. A second mobilization will be performed at the distal segment of the 1st Tarsometatarsal joint. These mobilizations will be performed by a board certified orthopaedic physical therapist with 14-yrs of practice experience. No equipment will be required to perform the joint mobilization. | Other | Joint Mobilization Arm |
Primary outcome
Changes in midfoot frontal plane range of motion during stance phase of gait.
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Segmental motion will be assessed using motion capture and measured in degrees.
Changes in ultrasound thickness measures of the abductor hallucis
Time frame: Arm 1: Baseline, 4 wks.
Muscle thickness measures will be measured in cm.
Foot and Ankle Ability Measure (FAAM)
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Patient Report Outcome of Foot and Ankle Function
Changes in ultrasound thickness measures of the flexor digitorum brevis
Time frame: Arm 1: Baseline, 4 wks.
Muscle thickness measures will be measured in cm.
Changes in thickness measures of the flexor hallucis brevis
Time frame: Arm 1: Baseline, 4 wks.
Muscle thickness measures will be measured in cm.
16 secondary outcomes
Changes in Foot morphological measurements across loading conditions
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of forefoot frontal plane range of motion
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of range of motion of first ray flexion/extension
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of joint laxity of the forefoot
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of joint laxity of the first ray
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of toe flexor strength
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle inversion strength
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle eversion strength
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle dorsiflexion strength
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Changes in Clinical Measures of ankle plantarflexion strength
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Star excursion balance test
Time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
12-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Visual Analogue Scale (VAS)
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Godin leisure questionnaire
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
11-item Tampa Scale of Kinesiophobia (TSK-11)
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Global Rate of Change (GROC)
Time frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Background: PubMed 20926721Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
- Background: PubMed 25818717Feger MA, Herb CC, Fraser JJ, Glaviano N, Hertel J. Supervised rehabilitation versus home exercise in the treatment of acute ankle sprains: a systematic review. Clin Sports Med. 2015 Apr;34(2):329-46. doi: 10.1016/j.csm.2014.12.001. Epub 2015 Feb 14.
- Background: PubMed 20351590Delahunt E, Coughlan GF, Caulfield B, Nightingale EJ, Lin CW, Hiller CE. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med Sci Sports Exerc. 2010 Nov;42(11):2106-21. doi: 10.1249/MSS.0b013e3181de7a8a.
- Background: PubMed 9801078Gerber JP, Williams GN, Scoville CR, Arciero RA, Taylor DC. Persistent disability associated with ankle sprains: a prospective examination of an athletic population. Foot Ankle Int. 1998 Oct;19(10):653-60. doi: 10.1177/107110079801901002.
- Background: PubMed 10101985Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8. doi: 10.1001/archfami.8.2.143.
- Background: PubMed 12135444Konradsen L, Bech L, Ehrenbjerg M, Nickelsen T. Seven years follow-up after ankle inversion trauma. Scand J Med Sci Sports. 2002 Jun;12(3):129-35. doi: 10.1034/j.1600-0838.2002.02104.x.
- Background: PubMed 24287210Tanen L, Docherty CL, Van Der Pol B, Simon J, Schrader J. Prevalence of chronic ankle instability in high school and division I athletes. Foot Ankle Spec. 2014 Feb;7(1):37-44. doi: 10.1177/1938640013509670. Epub 2013 Nov 27.
- Background: PubMed 21460069Mok KM, Fong DT, Krosshaug T, Engebretsen L, Hung AS, Yung PS, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: 2 cases during the 2008 Beijing Olympics. Am J Sports Med. 2011 Jul;39(7):1548-52. doi: 10.1177/0363546511399384. Epub 2011 Apr 1. No abstract available.
- Background: PubMed 21824618Kristianslund E, Bahr R, Krosshaug T. Kinematics and kinetics of an accidental lateral ankle sprain. J Biomech. 2011 Sep 23;44(14):2576-8. doi: 10.1016/j.jbiomech.2011.07.014. Epub 2011 Aug 6.
- Background: PubMed 15886127Willems T, Witvrouw E, Delbaere K, De Cock A, De Clercq D. Relationship between gait biomechanics and inversion sprains: a prospective study of risk factors. Gait Posture. 2005 Jun;21(4):379-87. doi: 10.1016/j.gaitpost.2004.04.002.
- Background: PubMed 22967824Fong DT, Ha SC, Mok KM, Chan CW, Chan KM. Kinematics analysis of ankle inversion ligamentous sprain injuries in sports: five cases from televised tennis competitions. Am J Sports Med. 2012 Nov;40(11):2627-32. doi: 10.1177/0363546512458259. Epub 2012 Sep 11.
- Background: PubMed 19640309Fong DT, Chan YY, Mok KM, Yung PS, Chan KM. Understanding acute ankle ligamentous sprain injury in sports. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jul 30;1:14. doi: 10.1186/1758-2555-1-14.
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Ankle Sprain, Ankle Sprain Strain
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, ATC 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 Intrinsic Foot Strengthening and Joint Mobilization in people with Injuries, Ankle and Sprain of Foot, 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 12 inclusion and 10 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 3 May 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 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. 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?
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 midfoot frontal plane range of motion during stance phase of gait. (time frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks). The study lists 5 primary outcomes in all. 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 NCT02697461, which also lists 24 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 3 May 2017.