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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01438905
Other study ID # 11-16058
Secondary ID
Status Completed
Phase N/A
First received September 14, 2011
Last updated February 22, 2018
Start date September 2011
Est. completion date December 2012

Study information

Verified date February 2018
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Small amplitude (Grade IV) 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.
High velocity, low amplitude (Grade V) 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.

Locations

Country Name City State
United States Creighton University Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Creighton University Nebraska Foundation for Physical Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline and immediately after each manual therapy intervention; 1 week study
Primary 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.
Baseline and immediately after each manual therapy intervention; 1 week study
Primary 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.
Baseline and immediately after each manual therapy intervention; 1 week study
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