NCT00601471

Brief Summary

The overall aim of this project is to determine the effect of a tibiofibular joint manipulation on the neuromuscular response of the fibularis longus and soleus muscles in individuals with chronic ankle instability. Another aim of this study is to determine the long term effects of a tibiofibular joint manipulation on range of motion and self-reported function. We hypothesize that a manipulation applied at the distal tibiofibular joint will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores compared to a tibiofibular joint manipulation applied at the proximal joint. We further hypothesize that both distal and proximal tibiofibular joint manipulations will result in greater muscle activation, improved functional dorsiflexion ROM, and increases in FAAM scores than no treatment at all.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

June 24, 2010

Status Verified

June 1, 2010

Enrollment Period

2.8 years

First QC Date

January 14, 2008

Last Update Submit

June 23, 2010

Conditions

Keywords

ankle sprainankle injuriessprains and strains

Outcome Measures

Primary Outcomes (1)

  • Changes in muscle activation

    over a three week period

Secondary Outcomes (2)

  • changes in functional range of motion

    over a 3 week period

  • changes in function

    over a three week period

Study Arms (3)

1

EXPERIMENTAL

proximal tibiofibular manipulation

Other: proximal tibiofibular manipulation

2

EXPERIMENTAL

distal tibiofibular manipulation

Other: distal tibiofibular manipulation

3

NO INTERVENTION

no treatment

Other: no intervention

Interventions

proximal tibiofibular manipulation

1

distal tibiofibular manipulation

2

no intervention / control

3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of more than one ankle sprain
  • unilateral or bilateral
  • Complaint of chronic ankle instability (CAI) and qualified according to
  • "YES" responses on the Ankle Instability Instrument (AII)
  • Scoring at least an 85 on the Foot and Ankle Ability Measure (FAAM)

You may not qualify if:

  • Lower extremity injury in the past 6 months (including lateral ankle sprain)
  • Currently receiving physical therapy for a lower extremity injury
  • Have a previous history of lower extremity surgery
  • Have diagnosed ankle osteoarthritis or rheumatoid arthritis
  • Currently pregnant or breast feeding
  • History of connective tissue disorders (like Marfan's Syndrome or Ehlers Danlos Disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Ankle InjuriesSprains and Strains

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Jay Hertel, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 28, 2008

Study Start

April 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 24, 2010

Record last verified: 2010-06

Locations