NCT03446469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

February 12, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2018

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

January 23, 2018

Last Update Submit

April 19, 2018

Conditions

Ankle Injuries and Disorders : Chronic Ankle Instability

Keywords

Chronic ankle instabilityFunctional instabilityAnkle sprainpostural swayFascial Manipulation

Outcome Measures

Primary Outcomes (2)

  • Center of pressure (COP) velocity

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

    30 seconds

  • Center of pressure excursion

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

    30 seconds

Secondary Outcomes (2)

  • Ankle dorsiflexion range of motion

    1 week

  • Foot and Ankle Disability Index (FADI) questionnaire

    1 week

Study Arms (1)

Individuals with Chronic Ankle instability

EXPERIMENTAL

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

Other: Fascial Manipulation

Interventions

Fascial ManipulationOTHER

Myofascial release of densified centers of coordination

Individuals with Chronic Ankle instability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cumberland ankle instability score ≤27
  • Subjective feeling of giving way of the ankle
  • No history of acute injuries
  • Previous history of ankle sprain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Sports Science, Medicine and Research

Udupi, Karnataka, 576104, India

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

January 23, 2018

First Posted

February 26, 2018

Study Start

February 12, 2018

Primary Completion

April 15, 2018

Study Completion

April 19, 2018

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

IN(1)