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CompletedNCT03446469Updated Apr 20, 2018

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

An interventional study of Fascial Manipulation in Ankle Injuries and Disorders : Chronic Ankle Instability, sponsored by Manipal University. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-20.

Sponsored by Manipal University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankle Injuries and Disorders : Chronic Ankle Instability

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Keywords

  • Chronic ankle instability
  • Functional instability
  • Ankle sprain
  • postural sway
  • Fascial Manipulation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

Interventions

  • OtherFascial Manipulation

    Myofascial release of densified centers of coordination

05

What researchers measure

Primary outcomes

  1. Center of pressure (COP) velocity

    COP velocity represents total distance traveled by the COP over time.

    Time frame: 30 seconds

  2. Center of pressure excursion

    COP excursion represents the total distance traveled by the COP over the course of the trial duration

    Time frame: 30 seconds

Secondary outcomes

  1. 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

    Time frame: 1 week

  2. Foot and Ankle Disability Index (FADI) questionnaire

    Subjective questionnaire

    Time frame: 1 week

06

Study locations

1 site
  • Centre for Sports Science, Medicine and Research
    Udupi, Karnataka 576104, India
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03446469
Lead sponsor
Manipal University
Responsible party
Neha C. Kamani (Postgraduate student, Manipal University) — Principal investigator
First posted
Feb 26, 2018
Start date
Feb 12, 2018
Primary completion
Apr 15, 2018
Completion
Apr 19, 2018
Last update
Apr 20, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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