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

May 2, 2017 updated by: Jay Hertel, PhD, ATC, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

115

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

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Exercise and Sports Injury Laboratory, University of Virginia

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

Yes

Genders Eligible for Study

All

Description

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

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Measured with an inclinometer in degrees.
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
Measured with a goniometer in degrees.
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
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
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
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
Assessed using a handheld dynamometer in N
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
Assessed using a handheld dynamometer in N
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
Assessed using a handheld dynamometer in N
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
Assessed using a handheld dynamometer in N
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
Assessed using a handheld dynamometer in N
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
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
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
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
Patient Report Outcome of Pain
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
Patient Report Outcome of Physical Activity
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
Patient Report Outcome of Kinesiophobia
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
Patient Report Outcome of Change in Symptoms
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

May 9, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18550

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.

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