NCT00703456

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

11 months

First QC Date

June 20, 2008

Last Update Submit

April 15, 2016

Conditions

Keywords

Functional ankle instabilityBalance training

Outcome Measures

Primary Outcomes (1)

  • Vertical force variation

    6 weeks

Secondary Outcomes (1)

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

    6 weeks

Study Arms (2)

1

EXPERIMENTAL

Balance Training, 3 times a week for 4 weeks

Behavioral: Balance Training

2

NO INTERVENTION

Education/No intervention

Interventions

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

1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Wen Liu

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

June 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations