Trial record 3 of 76 for:    "balance impairment" OR "balance training" | Open Studies

The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Wen Liu, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00703456
First received: June 20, 2008
Last updated: February 14, 2013
Last verified: February 2013
  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

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

Resource links provided by NLM:


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 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Balance Training, 3 times a week for 4 weeks
Behavioral: Balance Training
balance training three days per week for 4 weeks during single limb standing
No Intervention: 2
Education/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 45 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Wen Liu, Ph.D.
Investigators
Principal Investigator: Wen Liu University of Kansas
  More Information

No publications provided

Responsible Party: Wen Liu, Ph.D., Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00703456     History of Changes
Other Study ID Numbers: 10866
Study First Received: June 20, 2008
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Functional ankle instability
Balance training

Additional relevant MeSH terms:
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 01, 2014