- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438905
Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability
Effect of Joint Mobilization on Muscle Activation and Function in Individuals With Chronic Ankle Instability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68178
- Creighton University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
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Experimental: Lower intensity mobilization
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.
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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.
|
Experimental: Higher intensity mobilization
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Muscle activation
Time Frame: Baseline and immediately after each manual therapy intervention; 1 week study
|
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. |
Baseline and immediately after each manual therapy intervention; 1 week study
|
Changes in Ankle dorsiflexion ROM
Time Frame: Baseline and immediately after each manual therapy intervention; 1 week study
|
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. |
Baseline and immediately after each manual therapy intervention; 1 week study
|
Changes in Dynamic Balance
Time Frame: Baseline and immediately after each manual therapy intervention; 1 week study
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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. |
Baseline and immediately after each manual therapy intervention; 1 week study
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-16058
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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