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

Primary Purpose

Ankle Injuries and Disorders : Chronic Ankle Instability

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Fascial Manipulation
Sponsored by
Manipal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries and Disorders : Chronic Ankle Instability focused on measuring Chronic ankle instability, Functional instability, Ankle sprain, postural sway, Fascial Manipulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Sports Science, Medicine and Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individuals with Chronic Ankle instability

Arm Description

Individuals with history of ankle sprains will be screened using the inclusion criteria before being included in the study

Outcomes

Primary Outcome Measures

Center of pressure (COP) velocity
COP velocity represents total distance traveled by the COP over time.
Center of pressure excursion
COP excursion represents the total distance traveled by the COP over the course of the trial duration

Secondary Outcome Measures

Ankle dorsiflexion range of motion
Amount of flexion that can occur at the ankle joint in a weight bearing lunge starting from a neutral position
Foot and Ankle Disability Index (FADI) questionnaire
Subjective questionnaire

Full Information

First Posted
January 23, 2018
Last Updated
April 19, 2018
Sponsor
Manipal University
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1. Study Identification

Unique Protocol Identification Number
NCT03446469
Brief Title
Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion
Official Title
Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion in Participants With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
April 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Manipal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries and Disorders : Chronic Ankle Instability
Keywords
Chronic ankle instability, Functional instability, Ankle sprain, postural sway, Fascial Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individuals with Chronic Ankle instability
Arm Type
Experimental
Arm Description
Individuals with history of ankle sprains will be screened using the inclusion criteria before being included in the study
Intervention Type
Other
Intervention Name(s)
Fascial Manipulation
Intervention Description
Myofascial release of densified centers of coordination
Primary Outcome Measure Information:
Title
Center of pressure (COP) velocity
Description
COP velocity represents total distance traveled by the COP over time.
Time Frame
30 seconds
Title
Center of pressure excursion
Description
COP excursion represents the total distance traveled by the COP over the course of the trial duration
Time Frame
30 seconds
Secondary Outcome Measure Information:
Title
Ankle dorsiflexion range of motion
Description
Amount of flexion that can occur at the ankle joint in a weight bearing lunge starting from a neutral position
Time Frame
1 week
Title
Foot and Ankle Disability Index (FADI) questionnaire
Description
Subjective questionnaire
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre for Sports Science, Medicine and Research
City
Udupi
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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