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Effects of Mobilization Versus Manipulation on Function in Participants Reporting CAI

Primary Purpose

Ankle Sprains

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobilization with Movement
Thrust Mobilization
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, Manual Therapy

Eligibility Criteria

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

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 (i.e., 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 (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity

Sites / Locations

  • Shenandoah University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mobilization with Movement

Thrust Mobilization

Arm Description

A weight- bearing mobilization directed to the talocrural joint in a standing position.

A high velocity, low amplitude thrust mobilization directed to the talocrural joint with the participant in a non-weight bearing position.

Outcomes

Primary Outcome Measures

Change in baseline Multiple Hop Test immediately after intervention and at 1 week follow-up.
The participants will hop between 10 pieces of white 2 x 2 cm tape. Participants will be instructed to hop once between each numbered marker and avoid any postural corrections. Participants will be allowed to progress if they were able to stand still keeping their hands on their hips at each marker. Three trials on each leg will be performed and amount of time to complete trial, number of fixed-support, and change-in-support balance strategies will be recorded. The average of the three trials will be taken.
Change in baseline weight bearing lunge test (WBLT) immediately after intervention and at 1 week follow-up.
Weight-bearing dorsiflexion range of motion (ROM) will be measured using the lunge test with a digital inclinometer (Acumar Single Digital Inclinometer Model ACU001) placed on a marked spot 15 cm below the base of the tibial tuberosity. Participants will place their hands on the wall and touch a vertical line with their knee, while keeping their knee in line with their second toe and their heel on the ground. Participants will perform three trials on either leg and the average of three test trials will be recorded.
Change in baseline Star Excursion Balance Test (SEBT) immediately after intervention and at 1 week follow-up.
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 immediately after intervention and at 1 week follow-up.
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 immediately after intervention and at 1 week follow-up.
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 Cumberland Ankle Instability Tool (CAIT) immediately after intervention and at 1 week follow-up.
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2019
Last Updated
April 16, 2019
Sponsor
Shenandoah University
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1. Study Identification

Unique Protocol Identification Number
NCT03918473
Brief Title
Effects of Mobilization Versus Manipulation on Function in Participants Reporting CAI
Official Title
Effects of Mobilization Versus Manipulation on Function in Participants Reporting Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenandoah University

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
The investigator's purpose is to compare the effects of talocrural joint mobilization with movement versus thrust mobilization 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 comparing the effects of mobilization with movement (MWM) versus thrust mobilization (TM) directed at the talocrural joint on functional performance 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 MWM or TM group. The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight inch step and both feet facing forward . The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied. The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. Each manual therapy technique will be performed once. An examiner, who is blinded to involved limb and group allocation, will perform a baseline, immediate follow-up, and one-week follow-up examination of range of motion and functional performance. The participants will complete subjective outcome measures at baseline, immediately post intervention, and at 1 week post intervention including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline, immediate follow-up, and one-week follow up assessments of the Multiple Hop Test (MHT), three directions of the Star Excursion Balance test (SEBT), and weight bearing lunge test (WBLT). 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, CAIT, MHT, WBLT, 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, Manual Therapy

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 with Movement
Arm Type
Experimental
Arm Description
A weight- bearing mobilization directed to the talocrural joint in a standing position.
Arm Title
Thrust Mobilization
Arm Type
Experimental
Arm Description
A high velocity, low amplitude thrust mobilization directed to the talocrural joint with the participant in a non-weight bearing position.
Intervention Type
Other
Intervention Name(s)
Mobilization with Movement
Intervention Description
The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight-inch step and both feet facing forward. The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied.
Intervention Type
Other
Intervention Name(s)
Thrust Mobilization
Intervention Description
The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. This manual therapy technique will be performed once.
Primary Outcome Measure Information:
Title
Change in baseline Multiple Hop Test immediately after intervention and at 1 week follow-up.
Description
The participants will hop between 10 pieces of white 2 x 2 cm tape. Participants will be instructed to hop once between each numbered marker and avoid any postural corrections. Participants will be allowed to progress if they were able to stand still keeping their hands on their hips at each marker. Three trials on each leg will be performed and amount of time to complete trial, number of fixed-support, and change-in-support balance strategies will be recorded. The average of the three trials will be taken.
Time Frame
Baseline, immediately after intervention, and 1 week
Title
Change in baseline weight bearing lunge test (WBLT) immediately after intervention and at 1 week follow-up.
Description
Weight-bearing dorsiflexion range of motion (ROM) will be measured using the lunge test with a digital inclinometer (Acumar Single Digital Inclinometer Model ACU001) placed on a marked spot 15 cm below the base of the tibial tuberosity. Participants will place their hands on the wall and touch a vertical line with their knee, while keeping their knee in line with their second toe and their heel on the ground. Participants will perform three trials on either leg and the average of three test trials will be recorded.
Time Frame
Baseline, immediately after intervention, and 1 week
Title
Change in baseline Star Excursion Balance Test (SEBT) immediately after intervention and at 1 week follow-up.
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, immediately after intervention, and 1 week
Title
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale immediately after intervention and at 1 week follow-up.
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, immediately after intervention, and 1 week
Title
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale immediately after intervention and at 1 week follow-up.
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, immediately after intervention, and 1 week
Title
Change in baseline Cumberland Ankle Instability Tool (CAIT) immediately after intervention and at 1 week follow-up.
Description
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.
Time Frame
Baseline, immediately after intervention, and 1 week

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
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 (i.e., 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 (i.e., 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 Bolton, PT, DPT
Phone
5405426540
Email
cbolton16@su.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sheri Hale, PT, PhD
Phone
5405457240
Email
shale2@su.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Bolton, PT, DPT
Organizational Affiliation
Shenandoah University Division of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenandoah University
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
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 Hale, PhD, PT
Phone
5405457240
Email
shale2@su.edu
First Name & Middle Initial & Last Name & Degree
Emily Blum, SPT
First Name & Middle Initial & Last Name & Degree
Lindsey Rodriguez, SPT
First Name & Middle Initial & Last Name & Degree
Daphne Batista, SPT
First Name & Middle Initial & Last Name & Degree
Andrea Choo, SPT
First Name & Middle Initial & Last Name & Degree
Brianna Virzi, SPT
First Name & Middle Initial & Last Name & Degree
John Knowlton, SPT
First Name & Middle Initial & Last Name & Degree
Tiffany Reynolds, SPT
First Name & Middle Initial & Last Name & Degree
Laura D'Costa, SPT

12. IPD Sharing Statement

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
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Effects of Mobilization Versus Manipulation on Function in Participants Reporting CAI

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