Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT00703456
Status:
WITHDRAWN
Last Update Posted:
2016-04-19
First Post:
2008-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
The Effect of Balance Training on Unloading Reaction in Individuals With Functional Ankle Instability
Status:
WITHDRAWN
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: