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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02697461
Enrollment
115
Registered
2016-03-03
Start date
2016-01-31
Completion date
2017-06-30
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injuries, Ankle, Sprain of Foot

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.

Interventions

OTHERIntrinsic 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.

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.

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in midfoot frontal plane range of motion during stance phase of gait.Arm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksSegmental motion will be assessed using motion capture and measured in degrees.
Changes in ultrasound thickness measures of the abductor hallucisArm 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, 2wksPatient Report Outcome of Foot and Ankle Function
Changes in ultrasound thickness measures of the flexor digitorum brevisArm 1: Baseline, 4 wks.Muscle thickness measures will be measured in cm.
Changes in thickness measures of the flexor hallucis brevisArm 1: Baseline, 4 wks.Muscle thickness measures will be measured in cm.

Secondary

MeasureTime frameDescription
Changes in Clinical Measures of joint laxity of the first rayArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability
Changes in Clinical Measures of toe flexor strengthArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle inversion strengthArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle eversion strengthArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed using a handheld dynamometer in N
Changes in Clinical Measures of ankle dorsiflexion strengthArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed using a handheld dynamometer in N
Godin leisure questionnaireArm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wksPatient Report Outcome of Physical Activity
Star excursion balance testArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksClinical 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, 2wksPatient Report Outcome of Function
Visual Analogue Scale (VAS)Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wksPatient Report Outcome of Pain
11-item Tampa Scale of Kinesiophobia (TSK-11)Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wksPatient Report Outcome of Kinesiophobia
Global Rate of Change (GROC)Arm 1: Baseline, 5 wks. Arm 2: Baseline, 1wk, 2wksPatient Report Outcome of Change in Symptoms
Changes in Clinical Measures of ankle plantarflexion strengthArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed using a handheld dynamometer in N
Changes in Foot morphological measurements across loading conditionsArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksMeasurement of foot length, truncated foot length, foot width, and arch height in cm.
Changes in Clinical Measures of forefoot frontal plane range of motionArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksMeasured with an inclinometer in degrees.
Changes in Clinical Measures of range of motion of first ray flexion/extensionArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksMeasured with a goniometer in degrees.
Changes in Clinical Measures of joint laxity of the forefootArm 1: Baseline, 1wk, 5 wks. Arm 2: Baseline, 1wk, 2wksAssessed manually using a 7 point categorical scale from 0=ankylosed to 6=joint instability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026