The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability - Full Text View

Sponsored by:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00703456

Purpose

The aim of this study is to determine the effect of a balance training intervention on the change in hyper-reactivity to unloading reaction, ankle joint laxity, ankle joint proprioception and evertor muscle weakness in individuals with functional ankle instability (FAI) using quantitative biomechanical and neuromuscular measurements.

We hypothesize that experimental FAI group will demonstrate a significant decline in unloading reaction following balance training while FAI control group will not show a significant decline in unloading reaction without training. We further hypothesize that experimental FAI group will demonstrate a significant improvement in the FAI score after the balance training measured by Ankle Instability questionnaire. Following balance training, there will be a significant correlation between the change in FAI score and change in the unloading reaction in the experimental group.

Condition	Intervention
Ankle Injury	Behavioral: Balance Training

MedlinePlus related topics: Ankle Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Vertical force variation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ankle inversion flexibility, ankle proprioception, ankle evertor strength, modified cumberland ankle instability tool questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Balance Training	Behavioral: Balance Training balance training three days per week for 4 weeks during single limb standing
2: No Intervention No intervention

Detailed Description:

Conflicting results have been reported regarding the effect of ankle sprain on the proprioceptive sensation of the ankle, peroneal muscle strength and ankle joint laxity in the past research studies related to FAI. In spite of controversies regarding etiological factors for FAI, balance training has been widely used in sports medicine clinics to treat FAI. Most of these studies have focused on the identification of postural control deficits in patients with FAI rather than trying to understand the mechanism of balance training on etiological factors of FAI.

Hyper-reactivity of the ankle joint with FAI may be an important factor for the ankle "giving way" episode. Patients may develop injury-induced hyper-reactivity for unloading reaction through an adaptation to physical conditions of the ankle joint after injury. Clinical studies performed with selective nerve blocks along with electrophysiology studies performed in animals have led to the generally accepted conclusion that enhanced pain induced by peripheral nerve injury is associated with increased spontaneous and evoked discharges from injured and/or adjacent uninjured nerves. Persistent primary afferent inputs are believed to cause a state of central (i.e. "spinal") sensitization and enhancing responses to sensory inputs i.e. hyper-reactivity.

The ankle "giving way" is a complex phenomenon where any mechanical and neuromuscular factor or a combination of mechanical and neuromuscular factors may be at fault including ankle hyper-reactivity, joint laxity, proprioceptive deficit, and muscle weakness. The purpose of this study is to examine the effect of balance training intervention on the various etiological factors of FAI and to develop an objective measurement for physiological features related to FAI.

The study will help us to understand the mechanism of balance training on FAI and help us to determine the scope and limitations of balance training on FAI subjects in clinical settings to evaluate treatment efficacy.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

aged from 18 to 45 years
unilateral functional ankle instability (grade II or III)
at least four weeks after acute lateral ankle sprain
ongoing symptom of ankle "giving way" episode during functional activities
active in exercise at least 2 hour per week
seeking medical treatment for ankle symptoms
being able to complete the test and training tasks.

Exclusion Criteria:

severe ankle pain and swelling
ankle surgery in either leg
gross limitation in ankle range of motion
lower extremity injury other than lateral ankle sprain in past 12 weeks, (5) current enrollment in formal rehabilitation program
history of insulin-dependent diabetes
any systemic disease that might interfere with sensory input or muscle function of the lower extremity
any joint disease or bony fracture in the lower extremity
any previous experience of intolerance to electrical stimulation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703456

Contacts

Contact: Wen Liu

913-588-4565

wliu@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Wen Liu 913-588-4565 wliu@kumc.edu

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Wen Liu

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Wen Liu PhD )
Study ID Numbers:	10866
Study First Received:	June 20, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00703456
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Functional ankle instability
Balance training

Study placed in the following topic categories:

Ankle Injuries
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on January 15, 2009