HealthyNCT06205069
The Immediate Effects of Tissue Flossing on Knee Flexion Range of Motion
A study testing Tissue flossing in people with Healthy, run by University Fernando Pessoa at 1 site in Portugal.
Trial summary
The purpose of this study is to verify the immediate effects of Tissue Flossing on knee flexion range of motion Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tissue flossing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Feb 2024to 29 Mar 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy people between 18 and 35 years old with normal mobility of the joints of the lower limbs of the body.
Who cannot join
- deformities in the region of the lower limbs of the body, complaints in this region in the last 6 months, surgical procedures, venous thrombotic disease, heart disease, respiratory disease, or neurological, orthopedic, dermatitis, or neuromuscular problems in the lower quadrant that may disrupt musculoskeletal function. Also high blood pressure, latex allergies, lymphedema and individuals taking anticoagulant medication, and cortisteroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effects of Tissue Flossing on Knee Flexion Range of Motion: A Randomized Controlled Trial
The purpose of this study is to verify the immediate effects of Tissue Flossing on knee flexion range of motion
Read the detailed description
After completing the questionnaire, 58 healthy participants will be randomly divided into two groups named Intervention Group (IG) (n=29) and Control Group (CG) (n=29).
In the first assessment (M0), knee flexion ranges will be measured using a goniometer. Then the control group (n=29), without Tissue Flossing and intervention group (n=29) with Tissue Flossing around the knee joint will be subjected to passive and then active mobilization of the knee joint. Immediately after the intervention/control, the two groups will be assessed again (M1).
- Conditions
- Healthy
- Being tested
- Tissue flossing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue flossingDevice
While the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The floss band will be applied to the knee of the dominant lower limb in the intervention group (IG). While the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap.
After applying the floss band, passive mobilization will be performed - 20 repetitions of knee flexion and extension and an active movement task - 20 squats. Participants will be instructed to perform knee flexion and extension to their extreme range of motion and to complete the mobility exercises within two minutes. After two minutes, the floss band will be removed and participants will be instructed to stand up and walk for a minute to allow blood to flow back to the foot. Receives: Device: Tissue flossing |
| Control group | No intervention | For the CG, after initial assessment, participants without a floss band will perform the same two functional movement tasks (active and passive) with 20 repetitions as the GI for 2 minutes. After two minutes, participants will be instructed to get up and walk for one minute like the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of knee range of motion
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1).
The knee flexion range of motion will be measured using a smartphone app "Goniometer Pro". The distance between the lateral femoral epicondyle and the center of the lateral malleolus will be assessed. To measure the knee flexion angle, the participant will be placed in the prone position with the hip and knee extended at 0° (goniometer initial position 0°) with the foot relaxed and the contralateral leg extended. For active range of motion, the participant will be asked to perform maximum knee flexion in the prone position. To measure passive movement, the examiner will perform maximum knee flexion on participants in the same position. The average of three repetitions of ranges of movement will be recorded with 30-second rest intervals.
Measured: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Feb 2024
- Primary completion12 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Cardoso, University Fernando Pessoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205069
- Sponsor's protocol ID
- ESS/FSA - 320/22
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Tissue Flossing on Knee Flexion Range of Motion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06205069
- Acronym / sponsor ID
- ESS/FSA - 320/22
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Fernando PessoaUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 12 Jan 2024 (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.
The purpose of this study is to verify the immediate effects of Tissue Flossing on knee flexion range of motion
Detailed description
After completing the questionnaire, 58 healthy participants will be randomly divided into two groups named Intervention Group (IG) (n=29) and Control Group (CG) (n=29).
In the first assessment (M0), knee flexion ranges will be measured using a goniometer. Then the control group (n=29), without Tissue Flossing and intervention group (n=29) with Tissue Flossing around the knee joint will be subjected to passive and then active mobilization of the knee joint. Immediately after the intervention/control, the two groups will be assessed again (M1).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: Tissue flossingThe floss band will be applied to the knee of the dominant lower limb in the intervention group (IG). While the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap. After applying the floss band, passive mobilization will be performed - 20 repetitions of knee flexion and extension and an active movement task - 20 squats. Participants will be instructed to perform knee flexion and extension to their extreme range of motion and to complete the mobility exercises within two minutes. After two minutes, the floss band will be removed and participants will be instructed to stand up and walk for a minute to allow blood to flow back to the foot. |
| Control group | No intervention | –For the CG, after initial assessment, participants without a floss band will perform the same two functional movement tasks (active and passive) with 20 repetitions as the GI for 2 minutes. After two minutes, participants will be instructed to get up and walk for one minute like the intervention group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy people between 18 and 35 years old with normal mobility of the joints of the lower limbs of the body.
Key exclusion criteria (1 listed)
- deformities in the region of the lower limbs of the body, complaints in this region in the last 6 months, surgical procedures, venous thrombotic disease, heart disease, respiratory disease, or neurological, orthopedic, dermatitis, or neuromuscular problems in the lower quadrant that may disrupt musculoskeletal function. Also high blood pressure, latex allergies, lymphedema and individuals taking anticoagulant medication, and cortisteroid therapy.
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 |
|---|---|---|
| Tissue flossingWhile the participant will stand and perform a slight knee flexion, the band will be rolled upwards from the tibial tuberosity to 5 cm above the femoral epicondyle. The patella will not be covered. Pressure will be produced by rolling the joint with 50% tension and 50% overlap. | Device | Intervention group |
Primary outcome
Change of knee range of motion
Time frame: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]
Data will be collected in two moments: baseline (M0) and after the intervention/control (M1). The knee flexion range of motion will be measured using a smartphone app "Goniometer Pro". The distance between the lateral femoral epicondyle and the center of the lateral malleolus will be assessed. To measure the knee flexion angle, the participant will be placed in the prone position with the hip and knee extended at 0° (goniometer initial position 0°) with the foot relaxed and the contralateral leg extended. For active range of motion, the participant will be asked to perform maximum knee flexion in the prone position. To measure passive movement, the examiner will perform maximum knee flexion on participants in the same position. The average of three repetitions of ranges of movement will be recorded with 30-second rest intervals.
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 4 Apr 2024.
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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 Tissue flossing in people with Healthy, run by University Fernando Pessoa at 1 site in Portugal.
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 1 inclusion and 1 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 4 Apr 2024. 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 Portugal. 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?
Change of knee range of motion (time frame: [Time Frame: Change from Baseline (M0) to Immediately after intervention or control (M1)]). 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 4 Apr 2024.