Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion

• ClinicalTrials.gov Identifier: NCT03446469
• Recruitment Status: Completed
• First Posted: February 26, 2018
• Last Update Posted: April 20, 2018
• Sponsor: Manipal University
• Information provided by (Responsible Party): Neha C. Kamani, Manipal University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Ankle Injuries and Disorders : Chronic Ankle Instability	Other: Fascial Manipulation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion in Participants With Chronic Ankle Instability
• Actual Study Start Date: February 12, 2018
• Actual Primary Completion Date: April 15, 2018
• Actual Study Completion Date: April 19, 2018

Arms and Interventions

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	Other: Fascial Manipulation; Myofascial release of densified centers of coordination

Outcome Measures

Primary Outcome Measures :

1. Center of pressure (COP) velocity [ Time Frame: 30 seconds ]
   COP velocity represents total distance traveled by the COP over time.
2. Center of pressure excursion [ Time Frame: 30 seconds ]
   COP excursion represents the total distance traveled by the COP over the course of the trial duration

Secondary Outcome Measures :

1. Ankle dorsiflexion range of motion [ Time Frame: 1 week ]
   Amount of flexion that can occur at the ankle joint in a weight bearing lunge starting from a neutral position
2. Foot and Ankle Disability Index (FADI) questionnaire [ Time Frame: 1 week ]
   Subjective questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

India

Centre for Sports Science, Medicine and Research

Udupi, Karnataka, India, 576104

Sponsors and Collaborators

Manipal University

More Information

• Responsible Party: Neha C. Kamani, Postgraduate student, Manipal University
• ClinicalTrials.gov Identifier: NCT03446469
• Other Study ID Numbers: ManipalU; CTRI/2018/02/011762 ( Registry Identifier: Clinical Trials Registry - India )
• First Posted: February 26, 2018
• Last Update Posted: April 20, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neha C. Kamani, Manipal University:

Chronic ankle instability; Functional instability; Ankle sprain; postural sway; Fascial Manipulation

Additional relevant MeSH terms:

Ankle Injuries; Leg Injuries; Wounds and Injuries