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Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small amplitude (Grade IV) mobilization
High velocity, low amplitude (Grade V) mobilization
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle Sprain, Chronic Ankle Instability, Ankle Mobilization, Talocrural Joint Mobilization, Cortical Muscle Activation, Spinal Muscle Activation

Eligibility Criteria

19 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 16-45 years
  • History of one or more ankle sprains
  • Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
  • At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

Exclusion Criteria:

  • Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
  • Diagnosed ankle osteoarthritis
  • History of ankle surgery that involves intra-articular fixation
  • Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures

Sites / Locations

  • Creighton University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Lower intensity mobilization

Higher intensity mobilization

Arm Description

Parameters will be identical to the lower intensity (Small amplitude oscillation mobilization; Grade IV) talocrural mobilization. No force, other than light hand contact will be applied by the therapist.

The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.

The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.

Outcomes

Primary Outcome Measures

Changes in Muscle activation
To determine cortical and spinal changes in muscle activation of the fibularis longus and soleus following one of three intervention protocols. Changes in cortical and spinal muscle activation will be measured by examining resting motor threshold via Transcranial Magnetic Stimulation and the H-reflex technique, respectively. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in a greater increase in cortical and spinal activation of the fibularis longus and soleus muscles than the lower intensity talocrural joint mobilization.
Changes in Ankle dorsiflexion ROM
To determine the changes in ankle dorsiflexion ROM following one of two talocrural joint mobilization techniques (higher or lower intensity) or control intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge. The investigators hypothesize that the higher intensity (Grade V) talocrural joint mobilization will result in a greater improvement in ankle dorsiflexion ROM than the lower intensity (Grade IV) talocrural joint mobilization and the control intervention will result in no change in ROM.
Changes in Dynamic Balance
To determine the acute changes in balance following one of two talocrural joint mobilization techniques or control intervention in individuals with CAI. Changes in balance will be quantified using the anterior, posteromedial, and posterolateral components of the Star Excursion Balance Test. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in greater improvements in reach distance in all three SEBT directions compared to the lower intensity talocrural joint mobilization.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2011
Last Updated
February 22, 2018
Sponsor
Creighton University
Collaborators
Nebraska Foundation for Physical Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT01438905
Brief Title
Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability
Official Title
Effect of Joint Mobilization on Muscle Activation and Function in Individuals With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
Collaborators
Nebraska Foundation for Physical Therapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.
Detailed Description
Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests ankle joint mobilization can improve contributions of spinal influences on ankle muscle activation in individuals with ankle joint pathology, but there is a considerable gap in understanding cortical contributions to muscle activation following joint injury. It is unknown how joint mobilization concurrently affects cortical and spinal neural motor pathways, as well as clinical measures of patient function. The overall aim of this grant is to determine the immediate effects of talocrural joint mobilization on cortical and spinal muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with chronic ankle instability (CAI). The secondary aims of this study will examine changes in ankle dorsiflexion range of motion (ROM) and dynamic balance. This innovate approach will provide the necessary scientific knowledge regarding the potential mechanism and efficacy of joint mobilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle Sprain, Chronic Ankle Instability, Ankle Mobilization, Talocrural Joint Mobilization, Cortical Muscle Activation, Spinal Muscle Activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Parameters will be identical to the lower intensity (Small amplitude oscillation mobilization; Grade IV) talocrural mobilization. No force, other than light hand contact will be applied by the therapist.
Arm Title
Lower intensity mobilization
Arm Type
Experimental
Arm Description
The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.
Arm Title
Higher intensity mobilization
Arm Type
Experimental
Arm Description
The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.
Intervention Type
Other
Intervention Name(s)
Small amplitude (Grade IV) mobilization
Intervention Description
The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.
Intervention Type
Other
Intervention Name(s)
High velocity, low amplitude (Grade V) mobilization
Other Intervention Name(s)
Manipulation, Grade V mobilization, High velocity, low amplitude thrust
Intervention Description
The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.
Primary Outcome Measure Information:
Title
Changes in Muscle activation
Description
To determine cortical and spinal changes in muscle activation of the fibularis longus and soleus following one of three intervention protocols. Changes in cortical and spinal muscle activation will be measured by examining resting motor threshold via Transcranial Magnetic Stimulation and the H-reflex technique, respectively. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in a greater increase in cortical and spinal activation of the fibularis longus and soleus muscles than the lower intensity talocrural joint mobilization.
Time Frame
Baseline and immediately after each manual therapy intervention; 1 week study
Title
Changes in Ankle dorsiflexion ROM
Description
To determine the changes in ankle dorsiflexion ROM following one of two talocrural joint mobilization techniques (higher or lower intensity) or control intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge. The investigators hypothesize that the higher intensity (Grade V) talocrural joint mobilization will result in a greater improvement in ankle dorsiflexion ROM than the lower intensity (Grade IV) talocrural joint mobilization and the control intervention will result in no change in ROM.
Time Frame
Baseline and immediately after each manual therapy intervention; 1 week study
Title
Changes in Dynamic Balance
Description
To determine the acute changes in balance following one of two talocrural joint mobilization techniques or control intervention in individuals with CAI. Changes in balance will be quantified using the anterior, posteromedial, and posterolateral components of the Star Excursion Balance Test. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in greater improvements in reach distance in all three SEBT directions compared to the lower intensity talocrural joint mobilization.
Time Frame
Baseline and immediately after each manual therapy intervention; 1 week study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 16-45 years History of one or more ankle sprains Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII). At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21° Exclusion Criteria: Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain) Diagnosed ankle osteoarthritis History of ankle surgery that involves intra-articular fixation Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry L Grindstaff, PhD, PT, ATC
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27662790
Citation
Grindstaff TL, Dolan N, Morton SK. Ankle dorsiflexion range of motion influences Lateral Step Down Test scores in individuals with chronic ankle instability. Phys Ther Sport. 2017 Jan;23:75-81. doi: 10.1016/j.ptsp.2016.07.008. Epub 2016 Jul 29.
Results Reference
derived

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Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability

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