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WithdrawnNCT00703456Updated Apr 19, 2016

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

An interventional study of Balance Training in Ankle Injury, sponsored by University of Kansas Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by University of Kansas Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ankle Injury

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Keywords

  • Functional ankle instability
  • Balance training
03

In context

Ankle Injuries

362 studies on the registry are indexed under Ankle Injuries; 72 are open to participants now.

Browse Ankle Injuries studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Balance Training, 3 times a week for 4 weeks

    Behavioral: Balance Training

  • No intervention
    2

    Education/No intervention

Interventions

  • BehavioralBalance Training

    balance training three days per week for 4 weeks during single limb standing

06

What researchers measure

Primary outcomes

  1. Vertical force variation

    Time frame: 6 weeks

Secondary outcomes

  1. ankle inversion flexibility, ankle proprioception, ankle evertor strength, modified cumberland ankle instability tool questionnaire

    Time frame: 6 weeks

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00703456
Responsible party
Sponsor
First posted
Jun 23, 2008
Start date
Jun 2008
Primary completion
May 2009
Completion
May 2009
Last update
Apr 19, 2016

Study contacts

Wen Liu
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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