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

NCT02697461 | Unknown

• 1 other identifier: 18550
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Injuries, Ankle; Sprain of Foot

Outcome Measures

Primary Outcomes (5)

• 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

• Changes in ultrasound thickness measures of the abductor hallucis

  Muscle thickness measures will be measured in cm.

  Arm 1: Baseline, 4 wks.

• Foot and Ankle Ability Measure (FAAM)

  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

  Muscle thickness measures will be measured in cm.

  Arm 1: Baseline, 4 wks.

• Changes in thickness measures of the flexor hallucis brevis

  Muscle thickness measures will be measured in cm.

  Arm 1: Baseline, 4 wks.

Secondary Outcomes (16)

• Changes in Foot morphological measurements across loading conditions

  Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks

• Changes in Clinical Measures of forefoot frontal plane range of motion

  Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks

• Changes in Clinical Measures of range of motion of first ray flexion/extension

  Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks

• Changes in Clinical Measures of joint laxity of the forefoot

  Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks

• Changes in Clinical Measures of joint laxity of the first ray

  Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wks

Study Arms (2)

Intrinsic Foot Arm

EXPERIMENTAL

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

Joint Mobilization Arm

EXPERIMENTAL

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

Interventions

Intrinsic Foot Strengthening OTHER

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.

Intrinsic Foot Arm

Joint Mobilization OTHER

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.

Joint Mobilization Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Exercise and Sports Injury Laboratory, University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Jay Hertel, PhD, ATC

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: March 3, 2016
• Study Start: January 1, 2016
• Primary Completion: May 9, 2017
• Study Completion: June 1, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)