Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability

Injuries, Ankle Clinical Trial

Official title:

Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02697461
• Other study ID #: 18550
• Status: Active, not recruiting
• Phase: N/A
• First received: January 11, 2016
• Last updated: May 2, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2017
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: June 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

• 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.

Exclusion Criteria:

• 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

• Lumbosacral radiculopathy

• Soft tissue disorders including Marfan's syndrome and Ehlers-Dandros syndrome

• Absolute contraindications to manual therapy

• Pregnancy

Related Conditions & MeSH terms

• Ankle Injuries
• Injuries, Ankle
• Sprain of Foot
• Sprains and Strains

Intervention

Other:
• Intrinsic Foot Strengthening
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 Mobilization
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.

Locations

Country	Name	City	State
United States	Exercise and Sports Injury Laboratory, University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (24)

Blakeslee TJ, Morris JL. Cuboid syndrome and the significance of midtarsal joint stability. J Am Podiatr Med Assoc. 1987 Dec;77(12):638-42. — View Citation

Bonnel F, Toullec E, Mabit C, Tourné 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. Review. — View Citation

Braun 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. — View Citation

Delahunt 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. Review. — View Citation

Drummond DS, Hastings DE. Total dislocation of the cuboid bone. Report of a case. J Bone Joint Surg Br. 1969 Nov;51(4):716-8. — View Citation

Fagel VL, Ocon E, Cantarella JC, Feldman F. Case report 183: dislocation of the cuboid bone without fracture. Skeletal Radiol. 1982 Jan;7(4):287-8. — View Citation

Feger 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. Review. — View Citation

Fong DT, Chan YY, Mok KM, Yung PSh, 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. — View Citation

Fong 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. — View Citation

Gerber 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. — View Citation

Gough DT, Broderick DF, Januzik SJ, Cusack TJ. Dislocation of the cuboid bone without fracture. Ann Emerg Med. 1988 Oct;17(10):1095-7. — View Citation

Jacobsen FS. Dislocation of the cuboid. Orthopedics. 1990 Dec;13(12):1387-9. — View Citation

Kollmannsberger A, De Boer P. Isolated calcaneo-cuboid dislocation: brief report. J Bone Joint Surg Br. 1989 Mar;71(2):323. — View Citation

Konradsen 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. — View Citation

Kristianslund 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. — View Citation

Littlejohn SG, Line LL, Yerger LB Jr. Complete cuboid dislocation. Orthopedics. 1996 Feb;19(2):175-6. — View Citation

Martin RL, Davenport TE, Paulseth S, Wukich DK, Godges JJ; Orthopaedic Section American Physical Therapy Association.. Ankle stability and movement coordination impairments: ankle ligament sprains. J Orthop Sports Phys Ther. 2013 Sep;43(9):A1-40. doi: 10.2519/jospt.2013.0305. — View Citation

McDonough MW, Ganley JV. Dislocation of the cuboid. J Am Podiatry Assoc. 1973 Jul;63(7):317-8. — View Citation

Mok 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. — View Citation

Søndergaard L, Konradsen L, Hølmer P, Jørgensen LN, Nielsen PT. Acute midtarsal sprains: frequency and course of recovery. Foot Ankle Int. 1996 Apr;17(4):195-9. — View Citation

Tanen 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. — View Citation

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. — View Citation

Wei 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. — View Citation

Willems 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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Primary	Changes in ultrasound thickness measures of the abductor hallucis	Muscle thickness measures will be measured in cm.	Arm 1: Baseline, 4 wks.
Primary	Foot and Ankle Ability Measure (FAAM)	Patient Report Outcome of Foot and Ankle Function	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Primary	Changes in ultrasound thickness measures of the flexor digitorum brevis	Muscle thickness measures will be measured in cm.	Arm 1: Baseline, 4 wks.
Primary	Changes in thickness measures of the flexor hallucis brevis	Muscle thickness measures will be measured in cm.	Arm 1: Baseline, 4 wks.
Secondary	Changes in Foot morphological measurements across loading conditions	Measurement of foot length, truncated foot length, foot width, and arch height in cm.	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of forefoot frontal plane range of motion	Measured with an inclinometer in degrees.	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of range of motion of first ray flexion/extension	Measured with a goniometer in degrees.	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	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	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	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	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of toe flexor strength	Assessed using a handheld dynamometer in N	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of ankle inversion strength	Assessed using a handheld dynamometer in N	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of ankle eversion strength	Assessed using a handheld dynamometer in N	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of ankle dorsiflexion strength	Assessed using a handheld dynamometer in N	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Changes in Clinical Measures of ankle plantarflexion strength	Assessed using a handheld dynamometer in N	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Star excursion balance test	Clinical test of single limb reach/balance in the anterior, posterior lateral, and posterior medial directions in cm.	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	12-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)	Patient Report Outcome of Function	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Visual Analogue Scale (VAS)	Patient Report Outcome of Pain	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Godin leisure questionnaire	Patient Report Outcome of Physical Activity	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	11-item Tampa Scale of Kinesiophobia (TSK-11)	Patient Report Outcome of Kinesiophobia	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Secondary	Global Rate of Change (GROC)	Patient Report Outcome of Change in Symptoms	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks