- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446469
Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion
Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion in Participants With Chronic Ankle Instability
Fascia is defined as the soft tissue component of the connective tissue system. It is a continuous mesh that has several functions such as maintaining structural integrity and providing support and protection. Ligaments are part of the dense connective tissue system.
Studies conducted for ankle retinacula, which are thickened bands of fascia, also confirmed the presence of nervous tissue and proprioceptors within. Specific changes are seen in the MRI of ankle retinacula of individuals with chronic ankle instability. These changes include thickening of subcutaneous tissue. These structural changes may be responsible for interrupting the signals from the mechanoreceptors or also in damaging them.
Since fascial manipulation can help reduce the densifications of deep fascia, it is possible that on restoring the original structural and material properties, the proprioception may improve due to clearer signals from the mechanoreceptors. For a normal individual, recurrent sprains may lead to occupational absence and difficulty with their ADLs. Hence, there is a need for this study to determine the influence of FM on chronic ankle instability.
Study Overview
Status
Intervention / Treatment
Detailed Description
Chronic ankle instability (CAI) is defined as "repetitive bouts of lateral ankle instability due to the sprain of the lateral collateral ligament of the ankle, resulting in numerous ankle sprains, episodes of giving way and decreased physical activity.
Individuals with chronic ankle instability often complain of repeated turning of the ankle especially on uneven surfaces, self-reported feelings of the ankle feeling wobbly way and a past history of at least one severe lateral ankle sprain.
The recurrence of ankle sprains can be attributed to the proprioceptive deficits that occur due to joint deafferentation. Freeman et al originally proposed that joint deafferentation is the loss of sensory input from the articular mechanoreceptors located in the capsule and ligaments of the affected joint. Proprioceptive deficits manifest in the form of impaired balance and postural control.
The objective of the study is to determine the effectiveness of fascial manipulation on improving ankle instability by measuring pre- and post-intervention measures of postural sway and ankle range of motion.
Luigi Stecco's biomechanical model acts as the foundation for describing the framework of the fascial system. This model describes a myofascial unit (MFU) as the functional unit of this system. A myofascial unit consists of unidirectional muscle fibers, fascia, nerve structures and other retinacular structures such as joint capsules and ligaments. Two crucial points can be identified along a myofascial unit. These points are known as the centre of perception (CP) and centre of coordination (CC). A total of six myofascial units have been established for each body segment and it is in these myofascial units that dysfunction will be seen. The indication or exhibition of these dysfunctions varies from one individual to the next. However, the etiology remains universal i.e. densification of the CC due to abnormal tensile and mechanical stresses. Movement and palpation assessments are carried out to identify the involved CCs which are focused on during treatment using fascial manipulation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karnataka
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Udupi, Karnataka, India, 576104
- Centre for Sports Science, Medicine and Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cumberland ankle instability score ≤27
- Subjective feeling of giving way of the ankle
- No history of acute injuries
- Previous history of ankle sprain
Exclusion Criteria:
- Lower limb surgery
- Neurological disorders with balance impairments (e.g. Parkinson's disease, Alzheimer's disease, stroke, multiple sclerosis)
- Known history of Diagnosed diabetic neuropathy
- Vestibular balance disorders
- Deformities of the foot
- History of acute ankle sprain
- Skin lesions localized to the affected lower limb
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Individuals with Chronic Ankle instability
Individuals with history of ankle sprains will be screened using the inclusion criteria before being included in the study
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Myofascial release of densified centers of coordination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Center of pressure (COP) velocity
Time Frame: 30 seconds
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COP velocity represents total distance traveled by the COP over time.
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30 seconds
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Center of pressure excursion
Time Frame: 30 seconds
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COP excursion represents the total distance traveled by the COP over the course of the trial duration
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30 seconds
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle dorsiflexion range of motion
Time Frame: 1 week
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Amount of flexion that can occur at the ankle joint in a weight bearing lunge starting from a neutral position
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1 week
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Foot and Ankle Disability Index (FADI) questionnaire
Time Frame: 1 week
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Subjective questionnaire
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1 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- ManipalU
- CTRI/2018/02/011762 (REGISTRY: Clinical Trials Registry - India)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Ankle Injuries and Disorders : Chronic Ankle Instability
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Georgia State UniversityNational Athletic Trainers' Association Research & Education Foundation (NATA...CompletedChronic Ankle Instability | Ankle Sprains | Ankle RehabilitationUnited States
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University of North Carolina, Chapel HillAcademy of Orthopaedic Physical TherapyCompletedChronic Ankle InstabilityUnited States
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Linnaeus UniversityCompletedChronic Ankle InstabilitySweden
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