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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03446469
Other study ID # ManipalU
Secondary ID CTRI/2018/02/011
Status Completed
Phase N/A
First received January 23, 2018
Last updated April 19, 2018
Start date February 12, 2018
Est. completion date April 19, 2018

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 19, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Ankle Injuries
  • Ankle Injuries and Disorders : Chronic Ankle Instability

Intervention

Other:
Fascial Manipulation
Myofascial release of densified centers of coordination

Locations

Country Name City State
India Centre for Sports Science, Medicine and Research Udupi Karnataka

Sponsors (1)

Lead Sponsor Collaborator
Manipal University

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center of pressure (COP) velocity COP velocity represents total distance traveled by the COP over time. 30 seconds
Primary Center of pressure excursion COP excursion represents the total distance traveled by the COP over the course of the trial duration 30 seconds
Secondary 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 1 week
Secondary Foot and Ankle Disability Index (FADI) questionnaire Subjective questionnaire 1 week
See also
  Status Clinical Trial Phase
Recruiting NCT05942417 - Echoguided Percutaneous Neuromodulation in the Management of Chronic Ankle Instability in Physically Active Subjects. N/A