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

Primary Purpose

Injuries, Ankle, Sprain of Foot

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intrinsic Foot Strengthening
Joint Mobilization
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Ankle

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Exercise and Sports Injury Laboratory, University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intrinsic Foot Arm

Joint Mobilization Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Changes in ultrasound thickness measures of the abductor hallucis
Muscle thickness measures will be measured in cm.
Foot and Ankle Ability Measure (FAAM)
Patient Report Outcome of Foot and Ankle Function
Changes in ultrasound thickness measures of the flexor digitorum brevis
Muscle thickness measures will be measured in cm.
Changes in thickness measures of the flexor hallucis brevis
Muscle thickness measures will be measured in cm.

Secondary Outcome Measures

Changes in Foot morphological measurements across loading conditions
Measurement of foot length, truncated foot length, foot width, and arch height in cm.
Changes in Clinical Measures of forefoot frontal plane range of motion
Measured with an inclinometer in degrees.
Changes in Clinical Measures of range of motion of first ray flexion/extension
Measured with a goniometer in degrees.
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
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
Changes in Clinical Measures of toe flexor strength
Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle inversion strength
Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle eversion strength
Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle dorsiflexion strength
Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle plantarflexion strength
Assessed using a handheld dynamometer in N
Star excursion balance test
Clinical test of single limb reach/balance in the anterior, posterior lateral, and posterior medial directions in cm.
12-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)
Patient Report Outcome of Function
Visual Analogue Scale (VAS)
Patient Report Outcome of Pain
Godin leisure questionnaire
Patient Report Outcome of Physical Activity
11-item Tampa Scale of Kinesiophobia (TSK-11)
Patient Report Outcome of Kinesiophobia
Global Rate of Change (GROC)
Patient Report Outcome of Change in Symptoms

Full Information

First Posted
January 11, 2016
Last Updated
May 2, 2017
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02697461
Brief Title
Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability
Official Title
Multisegmented Foot Motion in Patients With Lateral Ankle Sprains and Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 9, 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Ankle, Sprain of Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrinsic Foot Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Joint Mobilization Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Intrinsic Foot Strengthening
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Joint Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in midfoot frontal plane range of motion during stance phase of gait.
Description
Segmental motion will be assessed using motion capture and measured in degrees.
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in ultrasound thickness measures of the abductor hallucis
Description
Muscle thickness measures will be measured in cm.
Time Frame
Arm 1: Baseline, 4 wks.
Title
Foot and Ankle Ability Measure (FAAM)
Description
Patient Report Outcome of Foot and Ankle Function
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in ultrasound thickness measures of the flexor digitorum brevis
Description
Muscle thickness measures will be measured in cm.
Time Frame
Arm 1: Baseline, 4 wks.
Title
Changes in thickness measures of the flexor hallucis brevis
Description
Muscle thickness measures will be measured in cm.
Time Frame
Arm 1: Baseline, 4 wks.
Secondary Outcome Measure Information:
Title
Changes in Foot morphological measurements across loading conditions
Description
Measurement of foot length, truncated foot length, foot width, and arch height in cm.
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of forefoot frontal plane range of motion
Description
Measured with an inclinometer in degrees.
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of range of motion of first ray flexion/extension
Description
Measured with a goniometer in degrees.
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of joint laxity of the forefoot
Description
Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of joint laxity of the first ray
Description
Assessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of toe flexor strength
Description
Assessed using a handheld dynamometer in N
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of ankle inversion strength
Description
Assessed using a handheld dynamometer in N
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of ankle eversion strength
Description
Assessed using a handheld dynamometer in N
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of ankle dorsiflexion strength
Description
Assessed using a handheld dynamometer in N
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Changes in Clinical Measures of ankle plantarflexion strength
Description
Assessed using a handheld dynamometer in N
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Star excursion balance test
Description
Clinical test of single limb reach/balance in the anterior, posterior lateral, and posterior medial directions in cm.
Time Frame
Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
12-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)
Description
Patient Report Outcome of Function
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Visual Analogue Scale (VAS)
Description
Patient Report Outcome of Pain
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Godin leisure questionnaire
Description
Patient Report Outcome of Physical Activity
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
11-item Tampa Scale of Kinesiophobia (TSK-11)
Description
Patient Report Outcome of Kinesiophobia
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks
Title
Global Rate of Change (GROC)
Description
Patient Report Outcome of Change in Symptoms
Time Frame
Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Hertel, PhD, ATC
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise and Sports Injury Laboratory, University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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

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