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

• ClinicalTrials.gov Identifier: NCT02697461
• Recruitment Status: Unknown
• First Posted: March 3, 2016
• Last Update Posted: May 3, 2017
• Sponsor: University of Virginia
• Information provided by (Responsible Party): Jay Hertel, PhD, ATC, University of Virginia

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Injuries, Ankle; Sprain of Foot	Other: Intrinsic Foot Strengthening; Other: Joint Mobilization	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability
• Study Start Date: January 2016
• Estimated Primary Completion Date: May 9, 2017
• Estimated Study Completion Date: June 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intrinsic Foot Arm; 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.	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.
Experimental: Joint Mobilization Arm; 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	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Changes in ultrasound thickness measures of the abductor hallucis [ Time Frame: Arm 1: Baseline, 4 wks. ]
   Muscle thickness measures will be measured in cm.
3. 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
4. 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.
5. Changes in thickness measures of the flexor hallucis brevis [ Time Frame: Arm 1: Baseline, 4 wks. ]
   Muscle thickness measures will be measured in cm.

Secondary Outcome Measures :

1. Changes in Foot morphological measurements across loading conditions [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Measurement of foot length, truncated foot length, foot width, and arch height in cm.
2. Changes in Clinical Measures of forefoot frontal plane range of motion [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Measured with an inclinometer in degrees.
3. 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 ]
   Measured with a goniometer in degrees.
4. Changes in Clinical Measures of joint laxity of the forefoot [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
5. Changes in Clinical Measures of joint laxity of the first ray [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
6. Changes in Clinical Measures of toe flexor strength [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed using a handheld dynamometer in N
7. Changes in Clinical Measures of ankle inversion strength [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed using a handheld dynamometer in N
8. Changes in Clinical Measures of ankle eversion strength [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed using a handheld dynamometer in N
9. Changes in Clinical Measures of ankle dorsiflexion strength [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
   Assessed using a handheld dynamometer in N
10. Changes in Clinical Measures of ankle plantarflexion strength [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Assessed using a handheld dynamometer in N
11. Star excursion balance test [ Time Frame: Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Clinical test of single limb reach/balance in the anterior, posterior lateral, and posterior medial directions in cm.
12. 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 ]
    Patient Report Outcome of Function
13. Visual Analogue Scale (VAS) [ Time Frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Patient Report Outcome of Pain
14. Godin leisure questionnaire [ Time Frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Patient Report Outcome of Physical Activity
15. 11-item Tampa Scale of Kinesiophobia (TSK-11) [ Time Frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Patient Report Outcome of Kinesiophobia
16. Global Rate of Change (GROC) [ Time Frame: Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks ]
    Patient Report Outcome of Change in Symptoms

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Virginia

Exercise and Sports Injury Laboratory, University of Virginia

Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

University of Virginia

Investigators

• Principal Investigator: Jay Hertel, PhD, ATC; University of Virginia

More Information

Publications:

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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.

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.

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• Responsible Party: Jay Hertel, PhD, ATC, Prinicipal Investigator, University of Virginia
• ClinicalTrials.gov Identifier: NCT02697461
• Other Study ID Numbers: 18550
• First Posted: March 3, 2016
• Last Update Posted: May 3, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Sprains and Strains; Ankle Injuries; Wounds and Injuries; Leg Injuries