Effects of Mobilization in Conjunction With Therapeutic Exercise in Participants With a History of Ankle Sprain

October 24, 2016 updated by: Cameron Jones, Shenandoah University

Effects of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability

Our purpose was to examine the combined effects of thrust mobilization of the proximal and distal ankle joints in conjunction with a six-week rehabilitation program on ankle function in subjects reporting chronic ankle instability (CAI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Joint mobilizations are reported to increase range of motion (ROM), postural control and proprioception, and decrease pain in individuals with CAI. There is no research supporting the combined effects of thrust mobilization and exercise on function in this population.

Inclusion and exclusion criterion were established and a convenience sample was performed. 19 subjects were randomized into the exercise only or mobilization (experimental) and exercise group. Both groups underwent 12 supervised training sessions across a six-week period. The mobilization (experimental) group also received high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.

An examiner blinded to involved limb and group allocation performed a baseline and six-week follow-up examination of muscle strength, joint mobility, range of motion, and/or functional performance. The participants completed subjective outcome measures at baseline, 2 weeks, 4 weeks, and finally at 6 weeks including the Functional Ankle Disability Index (FADI), FADI-Sport, and the Ankle Joint Functional Assessment Tool (AJFAT). Participants also completed baseline and a six-week follow up assessments of the figure-of-8 hop test, side hop test, and three directions of the Star Excursion Balance test (SEBT).

The exercise protocol is a modified version of the balance training program described by McKeon et al. Participants completed this protocol twice a week, for six weeks. Treatment sessions lasted approximately 30 minutes. Participants were individually progressed on particular exercises if zero errors were observed. In addition, all participants were given a home exercise program (HEP) to complete every day of the week excluding treatment days.

The mobilization (experimental) group received HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization was performed one time at each joint. The order of joint mobilizations was randomized prior to administering.

Data analysis was performed using International Business Machines Statistical Package for the Social Sciences (SPSS) version (22). Alpha level was set p<0.05. Separate 2 x 2 repeated measures analysis of variance (ANOVA) were used to assess changes in the FADI, FADI-Sport, figure-of-8 hop test, side hop test, and three directions of the SEBT.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Shenandoah University Division of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16 to 35 years old age
  • Self-reported history of an ankle sprain
  • Reports of "giving way" or a "loose" ankle within the past 6 months and/or decrease in functional status as compared to the uninvolved ankle

Exclusion Criteria:

  • Lower extremity injury within the past 3 months
  • History of vestibular dysfunction, neuromuscular diagnosis, mental illness, or if the participant was currently participating in another supervised rehabilitation program for the involved ankle.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Exercise Protocol
This exercise regimen is a modified version of the balance training program described by McKeon et al.
Other: Exercise Protocol
This exercise regimen is a modified version of the balance training program described by McKeon et al.
Other Names:
  • Control
Experimental: Mobilization
High Velocity Low Amplitude mobilization group. The three joints manipulated included proximal tibiofibular, the distal tibiofibular, and talocrural joints and were mobilized the first three sessions prior to the participants performing the exercise protocol.
Other: High Velocity Low Amplitude mobilization
Mobilizations were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
Other Names:
  • HVLA
  • thrust mobilization
Other: Exercise Protocol
This exercise regimen is a modified version of the balance training program described by McKeon et al.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline Figure-of-8 hop test at 6 weeks.
Time Frame: Baseline and 6 weeks
The participant began the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant was instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials were performed with the fastest time being recorded.
Baseline and 6 weeks
Change in baseline Side hop test at 6 weeks.
Time Frame: Baseline and 6 weeks
The participant stands on the involved limb on either side of two lines that are 30 cm apart. They were then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This was counted as two repetitions and 10 repetitions were performed. If the participant landed on or between the lines, this repetition was not counted and they continued until 10 good repetitions were completed. Participants performed two trials and the fastest time was recorded.
Baseline and 6 weeks
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks.
Time Frame: Baseline and 6 weeks
Each participant was asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Baseline and 6 weeks
Change in baseline Functional Ankle Disability Index (FADI) at 6 weeks.
Time Frame: Baseline, 2 week, 4 weeks, 6 weeks
The FADI is a 26-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored from 0 (unable to do) to 4 (no difficulty at all) and has total point value of 104 points.
Baseline, 2 week, 4 weeks, 6 weeks
Change in baseline Functional Ankle Disability Index (FADI)- Sport at 6 weeks.
Time Frame: Baseline, 2 week, 4 weeks, 6 weeks
The FADI-Sport is an 8-item tool that is a sub-scale of the FADI. Each item is scored with from 0 (unable to do) to 4 with a total point value of 32 points, reported as a percent value.
Baseline, 2 week, 4 weeks, 6 weeks
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks.
Time Frame: Baseline, 2 week, 4 weeks, 6 weeks
12-item tool that rates the participant's overall perceived level of function. Each item is assigned a point value from 0 (much less than other ankle) to 4 (much more than other ankle) with a possible total value of 48 points.
Baseline, 2 week, 4 weeks, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenandoah University

Investigators

  • Principal Investigator: Cameron R Jones, DPT, Shenandoah University Division of Physical Therapy
  • Principal Investigator: Sheri Hale, PhD, PT, Shenandoah University Division of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 12-1627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from subjective and objective outcome measures from all participants obtained prior to and after intervention have been analyzed.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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