Ankle Injuries and Disorders : Chronic Ankle InstabilityNCT03446469
Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion
A study testing Fascial Manipulation in people with Ankle Injuries and Disorders : Chronic Ankle Instability, run by Manipal University at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries and Disorders : Chronic Ankle Instability
- What is being tested?
- Fascial Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIndia
- Study dates
- 12 Feb 2018to 19 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cumberland ankle instability score ≤27
- Subjective feeling of giving way of the ankle
- No history of acute injuries
- Previous history of ankle sprain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Centre for Sports Science, Medicine and Research
Udupi, Karnataka, 576104
About this study
Official title: Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion in Participants With Chronic Ankle Instability
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.
- Being tested
- Fascial Manipulation
- Keywords
- Chronic ankle instability, Functional instability, Ankle sprain, postural sway, Fascial Manipulation
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial ManipulationOther
Myofascial release of densified centers of coordination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Fascial Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure (COP) velocity
COP velocity represents total distance traveled by the COP over time.
Measured: 30 seconds
Center of pressure excursion
COP excursion represents the total distance traveled by the COP over the course of the trial duration
Measured: 30 seconds
Secondary outcomes (2)
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
Measured: 1 week
Foot and Ankle Disability Index (FADI) questionnaire
Subjective questionnaire
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start12 Feb 2018
- Primary completion15 Apr 2018
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Injuries and Disorders : Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manipal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha C. Kamani, Manipal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446469
- Sponsor's protocol ID
- ManipalU
- Other IDs
- CTRI/2018/02/011762
- Status last verified
- Apr 2018
- First submitted
- 23 Jan 2018
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fascial Manipulation on Postural Sway and Ankle Range of Motion in Participants With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03446469
- Acronym / sponsor ID
- ManipalU
- Keywords
- Chronic ankle instability, Functional instability, Ankle sprain, postural sway, Fascial Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Manipal UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Chronic Ankle instability | Experimental | Other: Fascial ManipulationIndividuals with history of ankle sprains will be screened using the inclusion criteria before being included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cumberland ankle instability score ≤27
- Subjective feeling of giving way of the ankle
- No history of acute injuries
- Previous history of ankle sprain
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial ManipulationMyofascial release of densified centers of coordination | Other | Individuals with Chronic Ankle instability |
Primary outcome
Center of pressure (COP) velocity
Time frame: 30 seconds
COP velocity represents total distance traveled by the COP over time.
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
2 secondary outcomes
Ankle dorsiflexion range of motion
Time frame: 1 week
Foot and Ankle Disability Index (FADI) questionnaire
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Manipulation in people with Ankle Injuries and Disorders : Chronic Ankle Instability, run by Manipal University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure (COP) velocity (time frame: 30 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.