NCT01119092

Brief Summary

The purpose of this study is the examine the effects of gentle movements applied to the ankle joint and stretching on self-reported function, ankle motion and stiffness in individuals who have suffered from an ankle sprain within the last year and have decreased ankle motion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.3 years

First QC Date

May 5, 2010

Last Update Submit

May 26, 2011

Conditions

Keywords

Ankle SprainJoint MobilizationManual TherapyRange of Motion

Outcome Measures

Primary Outcomes (3)

  • Change in dorsiflexion range of motion

    Baseline and 4 weeks

  • Change in posterior talar glide

    Baseline and 4 weeks

  • Change in posterior talar translation

    Baseline and 4 weeks

Secondary Outcomes (2)

  • Change in self reported function

    Baseline and 4 weeks

  • Change in ankle stiffness

    Baseline and 4 weeks

Study Arms (3)

Sham intervention plus standard treatment

SHAM COMPARATOR

This group will receive a "laying of hands" treatment in addition to standard treatment. The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.

Other: Sham ("laying of hands") intervention

Control Group

NO INTERVENTION

This group will be individuals who suffer from the same injury but will be instructed to stretch at home 5 days a week for 2 weeks.

Grade IV AP joint mobilization plus standard treatment

EXPERIMENTAL

This group will receive 3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.

Other: Grade IV AP joint mobilizations

Interventions

The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.

Sham intervention plus standard treatment

3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.

Grade IV AP joint mobilization plus standard treatment

Eligibility Criteria

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

You may qualify if:

  • History of a lateral ankle sprain within the last year
  • Dorsiflexion range of motion deficit of 5°
  • Return to full activity prior to participation in this study
  • Individuals with dorsiflexion range of motion that is less than degrees of dorsiflexion.

You may not qualify if:

  • A history of ankle surgery that involves intra-articular fixation
  • Syndesmotic ankle sprain (to be ruled out based on the attending certified athletic trainers diagnosis)
  • A history or signs of reflex sympathetic dystrophy
  • Suffer from an acute injury in the lower extremity within the last 6 weeks
  • Have received manual therapy for the ankle sprain prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Interventions

salicylhydroxamic acidMethods

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jay Hertel, PhD

    University to Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 7, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations