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

Not Applicable

• Conditions: Injuries, Ankle; Sprain of Foot
• Interventions: Other: Intrinsic Foot Strengthening; Other: Joint Mobilization

• Registration Number: NCT02697461
• Lead Sponsor: University of Virginia

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-03-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Primary Completion: 2017-05-09
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 115

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intrinsic Foot Arm	Intrinsic Foot Strengthening	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.
Joint Mobilization Arm	Joint Mobilization	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

Primary Outcome Measures

Name	Time	Method
Changes in thickness measures of the flexor hallucis brevis	Arm 1: Baseline, 4 wks.	Muscle thickness measures will be measured in cm.
Changes in ultrasound thickness measures of the abductor hallucis	Arm 1: Baseline, 4 wks.	Muscle thickness measures will be measured in cm.
Changes in midfoot frontal plane range of motion during stance phase of gait.	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 flexor digitorum brevis	Arm 1: Baseline, 4 wks.	Muscle thickness measures will be measured in cm.
Foot and Ankle Ability Measure (FAAM)	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Foot and Ankle Function

Secondary Outcome Measures

Name	Time	Method
Changes in Clinical Measures of ankle inversion strength	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Assessed using a handheld dynamometer in N
Global Rate of Change (GROC)	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Change in Symptoms
Changes in Clinical Measures of joint laxity of the forefoot	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
Visual Analogue Scale (VAS)	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Pain
Changes in Foot morphological measurements across loading conditions	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.
Changes in Clinical Measures of range of motion of first ray flexion/extension	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Measured with a goniometer in degrees.
Changes in Clinical Measures of forefoot frontal plane range of motion	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Measured with an inclinometer in degrees.
Changes in Clinical Measures of joint laxity of the first ray	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
Changes in Clinical Measures of toe flexor strength	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle eversion strength	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle dorsiflexion strength	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Assessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle plantarflexion strength	Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks	Assessed using a handheld dynamometer in N
Godin leisure questionnaire	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Physical Activity
Star excursion balance test	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-Item Short Form Survey from the RAND Medical Outcomes Study (VR-12)	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Function
11-item Tampa Scale of Kinesiophobia (TSK-11)	Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wks	Patient Report Outcome of Kinesiophobia

Trial Locations

Locations (1)

Exercise and Sports Injury Laboratory, University of Virginia; 🇺🇸 Charlottesville, Virginia, United States