The Effect of Flossing to Joint Range of Motion.
Primary Purpose
Muscle, Ligament and Fascia Disorders
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Thomayer test
Sponsored by
About this trial
This is an interventional prevention trial for Muscle, Ligament and Fascia Disorders focused on measuring Muscle chains, fascia, range of motion, viscosity.
Eligibility Criteria
Inclusion Criteria:
- No previous experience with the tissue flossing method
- Each proband had to do recreational or elite sports
Exclusion Criteria:
- persons with an acute, especially infectious disease, person with an injury or persons in the process of recovery after an injury or illness
- vascular diseases
Sites / Locations
- Charles University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental group
Arm Description
Outcomes
Primary Outcome Measures
Measurement of range of motion of ankle in sagital line
Measurement without flossing of sole in natura
Measurement of range of motion of ankle in sagital line
Flossing of sole and than measurement after flossing of sole
Measurement of range of motion of lumbar spine in sagital line
Measurement before flossing of sole
Measurement of range of motion of lumbar spine in sagital line
Measurement after flossing of sole
Secondary Outcome Measures
Full Information
NCT ID
NCT04689698
First Posted
December 23, 2020
Last Updated
March 1, 2023
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04689698
Brief Title
The Effect of Flossing to Joint Range of Motion.
Official Title
Influence of Flossing Tape Therapy on the Range of Motion and Influencing of Fascial Chains in the Lower Limbs
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This research aims to verify the effect of therapy called "tissue flossing" on the range of motion and examine the impact of this treatment on the Superficial fascial backline, described by Myers. The research aims to verify whether the thick rubber bands used to create a certain degree of compression in a predetermined part of the musculoskeletal system can help to increase the range of motion (ROM) and whether this increase in motion can be achieved by influencing fascial chains even in distant parts of the musculoskeletal system, outside the primary therapeutic zone treated by the tissue flossing method. The research aims to verify and especially compare the patient's joints' range of motion before and immediately after the tissue flossing treatment. The results of the experiment clarify the influence of the tissue flossing therapy method on the range of motion at the application site, on the range of motion in other joints within the Superficial fascial backline described by Myers and last but not least to prove the existence of these fascial chains in the human body.
Detailed Description
Methodology:
The weight-bearing lunge test (WBLT) was used to evaluate the change in the ankle joint's range of motion. A simple forward bend test - the Thomayer test - was used to evaluate the therapy's effect on the Superficial fascial backline described by Myers. Both tests are non-invasive. Both tests can be used to evaluate the outcome of a given therapy objectively. Both tests are elementary to perform and highly standardized and commonly used in similar research.
After completing the entrance tests, the tissue flossing method is applied to each proband. The treatment alone does not typically last more than 20 minutes for any proband. As part of the tissue flossing treatment, both lower limbs of the proband will be treated. The "tissue flossing" method will be applied according to the authors' standard recommendations first to the plantar fascia area, then to the ankle joint. Finally, the last treated structure will be the area of fascia cruris. The duration of each application does not exceed 2 minutes. The order of individual applications is determined in advance as follows: right and then left plantar fascia, right and then left ankle joint and right and then left fascia cruris. Each application will be supplemented by the standard manual treatment or supplemented by the proband's active movement. After a total of 6 treatments, the therapeutic unit will be finished, and each proband will be re-examined using the same tests as before the treatment. If a given proband experiences any undesirable complications during the application of the "tissue flossing" method or applying the given method to the proband is subjectively unpleasant, the given treatment will be finished immediately.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle, Ligament and Fascia Disorders
Keywords
Muscle chains, fascia, range of motion, viscosity.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Thomayer test
Other Intervention Name(s)
Dorziflexion of an ankle
Intervention Description
Testing of the ankle in sagittal line and Thomayer test before and after flossing of sole.
Primary Outcome Measure Information:
Title
Measurement of range of motion of ankle in sagital line
Description
Measurement without flossing of sole in natura
Time Frame
5 minutes
Title
Measurement of range of motion of ankle in sagital line
Description
Flossing of sole and than measurement after flossing of sole
Time Frame
15 minutes
Title
Measurement of range of motion of lumbar spine in sagital line
Description
Measurement before flossing of sole
Time Frame
5 minutes
Title
Measurement of range of motion of lumbar spine in sagital line
Description
Measurement after flossing of sole
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No previous experience with the tissue flossing method
Each proband had to do recreational or elite sports
Exclusion Criteria:
persons with an acute, especially infectious disease, person with an injury or persons in the process of recovery after an injury or illness
vascular diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitka Malá, PhDr.Ph.D.
Organizational Affiliation
Charles University, Faculty of physical education and sport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles University
City
Praha
Country
Czechia
12. IPD Sharing Statement
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The Effect of Flossing to Joint Range of Motion.
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