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Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability

Primary Purpose

Ankle Sprains

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Velocity Low Amplitude mobilization
Exercise protocol
Sponsored by
Shenandoah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Functional Performance, Rehabilitation, Manipulation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

As adapted from the position statement from the international ankle consortium.

Inclusion Criteria:

  • 18-35 years of age
  • A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity)
  • The most recent injury must have occurred more than 3 months prior to study enrollment.
  • A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
  • Cumberland Ankle Instability Tool (CAIT) < 24
  • Foot and Ankle Ability Measure (FAAM)42: ADL scale < 90%, Sport scale < 80%

Exclusion Criteria:

  • A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
  • A history of a fracture in either limb of the lower extremity requiring realignment
  • Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity

Sites / Locations

  • Methodist UniversityRecruiting
  • Shenandoah UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobilization

Exercise Protocol

Arm Description

High Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol.

This exercise regimen is a modified version of the balance training program described by McKeon et al.

Outcomes

Primary Outcome Measures

Change in baseline Figure-of-8 hop test at 6 weeks.
The participant begins the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant is instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials will be performed with the fastest time being recorded.
Change in baseline Side hop test at 6 weeks
The participant stands on the involved limb on either side of two lines that are 30 cm apart. They are then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This is counted as two repetitions and 10 repetitions are performed. If the participant lands on or between the lines, this repetition does not count and they continue until 10 good repetitions are completed. Participants perform two trials and the fastest time is recorded.
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks
Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks
The FAAM- ADL is a 21-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) and has total point value of 84 points, reported as a percent value.
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks
The FAAM- Sport is a 7-item tool that is a sub-scale of the FAAM. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) with a total point value of 28 points, reported as a percent value.
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 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.
Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks.
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2018
Last Updated
April 16, 2018
Sponsor
Shenandoah University
Collaborators
Methodist University, North Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03428620
Brief Title
Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability
Official Title
Effect of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenandoah University
Collaborators
Methodist University, North Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI).
Detailed Description
Joint mobilizations are reported to increase range of motion (ROM), postural control and proprioception, and decrease pain in individuals with CAI. However, there is no research supporting the combined effects of thrust mobilization and exercise on function in this population. Inclusion and exclusion criterion have been established utilizing the International Ankle Consortium guidelines. Using a convenience sampling, participants will be randomized into the exercise only or mobilization (experimental) and exercise group. Both groups will undergo 12 supervised training sessions across a six-week period. The mobilization (experimental) group will also receive high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions. An examiner, who is blinded to involved limb and group allocation, will perform a baseline and six-week follow-up examination of joint mobility, range of motion, and functional performance. The participants will complete subjective outcome measures at baseline, 2 weeks, 4 weeks, and 6 weeks including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, Ankle Joint Functional Assessment Tool (AJFAT), and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline and 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 will complete this protocol twice a week for six weeks. Treatment sessions will last approximately 30 minutes. Participants will individually progress on particular exercises if zero errors are observed. In addition, all participants will be given a home exercise program (HEP) to complete every day of the week excluding treatment days. The mobilization (experimental) group will receive HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization will be performed one time at each joint. The order of joint mobilizations will be randomized prior to administering. Data analysis will be performed using International Business Machines Statistical Package for the Social Sciences (SPSS). Alpha level will be set p<0.05. Expecting to utilize separate 2 x 2 repeated measures analysis of variance (ANOVA) to assess changes in the FAAM, FAAM-Sport, AJFAT, CAIT, figure-of-8 hop test, side hop test, and three directions of the SEBT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains
Keywords
Functional Performance, Rehabilitation, Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobilization
Arm Type
Experimental
Arm Description
High Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol.
Arm Title
Exercise Protocol
Arm Type
Active Comparator
Arm Description
This exercise regimen is a modified version of the balance training program described by McKeon et al.
Intervention Type
Other
Intervention Name(s)
High Velocity Low Amplitude mobilization
Other Intervention Name(s)
HVLA, thrust mobilization
Intervention Description
Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
Intervention Type
Other
Intervention Name(s)
Exercise protocol
Intervention Description
This exercise regimen is a modified version of the balance training program described by McKeon et al.
Primary Outcome Measure Information:
Title
Change in baseline Figure-of-8 hop test at 6 weeks.
Description
The participant begins the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant is instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials will be performed with the fastest time being recorded.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Side hop test at 6 weeks
Description
The participant stands on the involved limb on either side of two lines that are 30 cm apart. They are then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This is counted as two repetitions and 10 repetitions are performed. If the participant lands on or between the lines, this repetition does not count and they continue until 10 good repetitions are completed. Participants perform two trials and the fastest time is recorded.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks
Description
Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks
Description
The FAAM- ADL is a 21-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) and has total point value of 84 points, reported as a percent value.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks
Description
The FAAM- Sport is a 7-item tool that is a sub-scale of the FAAM. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) with a total point value of 28 points, reported as a percent value.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks.
Description
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
As adapted from the position statement from the international ankle consortium. Inclusion Criteria: 18-35 years of age A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity) The most recent injury must have occurred more than 3 months prior to study enrollment. A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability." Cumberland Ankle Instability Tool (CAIT) < 24 Foot and Ankle Ability Measure (FAAM)42: ADL scale < 90%, Sport scale < 80% Exclusion Criteria: A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity. A history of a fracture in either limb of the lower extremity requiring realignment Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cameron J Bolton, DPT
Phone
5405426540
Email
cbolton16@su.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sheri Hale, PhD, PT
Phone
5405457240
Email
shale2@su.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron J Bolton, DPT
Organizational Affiliation
Shenandoah University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheri Hale, PhD, PT
Organizational Affiliation
Shenandoah University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist University
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28311
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Telemeco, DPT, PhD
Phone
910-630-7216
Email
ttelemeco@methodist.edu
First Name & Middle Initial & Last Name & Degree
Todd A Telemeco, DPT, PhD
First Name & Middle Initial & Last Name & Degree
Lindsay Edge, SPT
First Name & Middle Initial & Last Name & Degree
Jessica Campbell, SPT
First Name & Middle Initial & Last Name & Degree
Jenna Henry, SPT
First Name & Middle Initial & Last Name & Degree
Emilie Samp, SPT
Facility Name
Shenandoah University
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cameron Bolton, DPT
Phone
540-542-6540
Email
cbolton16@su.edu
First Name & Middle Initial & Last Name & Degree
Sheri, PhD, PT
Phone
5405457240
Email
shale2@su.edu
First Name & Middle Initial & Last Name & Degree
Megan Flaherty, SPT
First Name & Middle Initial & Last Name & Degree
Gabriele Moreno, SPT
First Name & Middle Initial & Last Name & Degree
Lyndsey McIntyre, SPT
First Name & Middle Initial & Last Name & Degree
Lauren Haffner, SPT
First Name & Middle Initial & Last Name & Degree
Jeffrey Wakefield, SPT
First Name & Middle Initial & Last Name & Degree
Meredith Bland, SPT
First Name & Middle Initial & Last Name & Degree
Lily Nealon, SPT
First Name & Middle Initial & Last Name & Degree
Hailey Goleta, SPT

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24377963
Citation
Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
Results Reference
background
PubMed Identifier
18799992
Citation
McKeon PO, Ingersoll CD, Kerrigan DC, Saliba E, Bennett BC, Hertel J. Balance training improves function and postural control in those with chronic ankle instability. Med Sci Sports Exerc. 2008 Oct;40(10):1810-9. doi: 10.1249/MSS.0b013e31817e0f92.
Results Reference
background
PubMed Identifier
17612356
Citation
Hale SA, Hertel J, Olmsted-Kramer LC. The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2007 Jun;37(6):303-11. doi: 10.2519/jospt.2007.2322.
Results Reference
background
PubMed Identifier
22333567
Citation
Beazell JR, Grindstaff TL, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Effects of a proximal or distal tibiofibular joint manipulation on ankle range of motion and functional outcomes in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2012 Feb;42(2):125-34. doi: 10.2519/jospt.2012.3729. Epub 2012 Feb 1.
Results Reference
background

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Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability

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