Ankle InstabilityNCT06491277
The Effect of Ankle Floss Band on Football Players
A study testing Flossband in people with Ankle Instability, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
There is no study in the literature investigating the effects of ankle stimulation with the flossband soft tissue technique on balance and proprioception. The impact of flossband use on flexibility and static and dynamic balance in the lower extremities requires further research. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Instability
- What is being tested?
- Flossband
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 24 May 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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 25 years old.
- Engaged in regular football training for at least 3 years.
Who cannot join
- History of fractures and surgeries in the lower extremities.
- Diagnosed with other ankle and lower extremity problems.
- Presence of pain in the ankle and lower extremities.
- Systemic conditions such as deep vein thrombosis and embolism.
- Experience of pain during any measurement.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat Üniversity
Antalya, Alanya, 07450
About this study
Official title: The Effect of Ankle Floss Band Application on Balance, Proprioception and Performance
There is no study in the literature investigating the effects of ankle stimulation with the flossband soft tissue technique on balance and proprioception. The impact of flossband use on flexibility and static and dynamic balance in the lower extremities requires further research. It is likely that flossband, which has been found to enhance sports performance, also affects balance, proprioception, and performance. More research is needed to evaluate the benefits of flossband use on body movements and motor control. Therefore, the aim of this study is to evaluate the effects of flossband on balance, proprioception, and performance, given its known impact on sports performance.
Read the detailed description
Objective: The aim of the study is to investigate the effects of exercises with flossband on balance, proprioception, and physical performance in the ankle.
Materials and Methods: Thirty-six football players were included in the study. As this was a serial group design the same football players were included in both the study group and the control group. There was a 72-hour break between the interventions for the study group and the control group. The study began with the study group. The study group received Flossband application while the control group received foam roller bandage application. The same exercises were conducted alongside both interventions. Measurements were taken before and after the interventions and exercises. Ankle dorsiflexion range of motion was evaluated using the weight-bearing lunge test, static balance using a smartphone application, dynamic balance using the Y-balance test, and proprioception using the joint position sense test. Additionally, the hop test was used to assess jumping performance.
- Conditions
- Ankle Instability
- Being tested
- Flossband, Controlled Group
- Keywords
- physical Functional performance, Floosband, Bandage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlossbandOther
The use of Flossband (Sanctband COMPRE Floss 5.1 cm × 3.5 m; Sanct Japan Co., Ltd.), made of natural rubber, was applied starting from 5 cm below the ankle joint line with a 50% stretch. The band tension was increased to 70-75% around 2 cm above the attachment point of the Achilles tendon.
Controlled GroupOther
Also called Sham
Cramer Tape Underwrap (7cm X 27m) foam bandage was applied starting 5 cm below the ankle joint line without tension. The control group received the same exercise protocol as the study group.
| Study group | Role | What they receive |
|---|---|---|
| Flossband Group | Active comparator | Our study began by applying flossband to the football players. The players were first assessed without the flossband, and then reassessed with the flossband to measure its effectiveness. This group was referred to as the 'Study Group.' Receives: Other: Flossband |
| Controlled Group | Sham comparator | After the specified rest period, the football players were evaluated prior to the foam roller application. Seventy-two hours later, they were reassessed with the foam roller to measure the effectiveness of the application. This group was referred to as the 'Control Group. Receives: Other: Controlled Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Bearing Lunge Test
The ankle dorsiflexion range of motion was evaluated. Three tests were conducted for each participant, and the best score was recorded. Each assessment was performed before and after taping.
Measured: 3 days
Static Balance Assesment
using the 'Accelerometer' application developed with Apple iPhone 14 and Dream Arc App Inventor, the static balance of football players was measured. Participants were instructed to stand on one leg for 30 seconds. Three trials were conducted, and the best score was recorded. The application recorded acceleration data in three axes (x, y, z) at a sampling rate of 20 Hz during the 30-second duration. Higher acceleration values indicated poorer balance.
Measured: 3 days
Dynamic Balance Test
The Y balance test is a dynamic assessment widely used among athletes, requiring strength, flexibility, and proprioception, with good reliability. For the test, three equal-length strips of tape are placed on the floor to form a Y shape with angles of 90°, 135°, and 135° between them. The foot to be tested is placed at the intersection of the tapes, and the athlete is instructed to reach as far as possible in three different directions (anterior, posterolateral, posteromedial) while maintaining balance with the other foot. Football players attempted to reach maximum distance in each of these three directions, and these distances were recorded. The highest score from three successful reaches in each direction was normalized relative to leg length.Each assessment was performed before and after taping.
Measured: 3 days
Proprioseptive Evaluation
When evaluating joint position sense, the football player was seated on a chair with their feet flat on the ground and eyes closed. Using a smartphone goniometer application, the range of motion of both ankles was measured. The tested ankle was passively moved into a dorsiflexion position of 10 degrees and then returned to its original position. The player was asked to actively replicate the same position with their foot, and the deviation from the target 10 degrees was recorded. This process was repeated three times, and the average deviation was calculated.Each assessment was performed before and after taping
Measured: 3 days.
Triple Hop Test
This is a commonly used test for evaluating the functional abilities of the ankle and knee joints. The test measures the participant's balance, performance, and joint stability. A 6-meter scale is prepared, and the football player is instructed to stand on the assessed foot with arms by the sides and knees bent at a 45-degree angle in the starting position. The player is asked to perform three maximal forward jumps and land on the same line with the foot used for jumping. The distance between the heel and the starting point is measured, and the longest of two attempts is recorded.Each assessment was performed before and after taping
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491277
- Sponsor's protocol ID
- 2023/01
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ankle Floss Band Application on Balance, Proprioception and Performance
- ClinicalTrials.gov ID
- NCT06491277
- Acronym / sponsor ID
- 2023/01
- Conditions
- Ankle Instability
- Keywords
- physical Functional performance, Floosband, Bandage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 9 Jul 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.
There is no study in the literature investigating the effects of ankle stimulation with the flossband soft tissue technique on balance and proprioception. The impact of flossband use on flexibility and static and dynamic balance in the lower extremities requires further research. It is likely that flossband, which has been found to enhance sports performance, also affects balance, proprioception, and performance. More research is needed to evaluate the benefits of flossband use on body movements and motor control. Therefore, the aim of this study is to evaluate the effects of flossband on balance, proprioception, and performance, given its known impact on sports performance.
Detailed description
Objective: The aim of the study is to investigate the effects of exercises with flossband on balance, proprioception, and physical performance in the ankle.
Materials and Methods: Thirty-six football players were included in the study. As this was a serial group design the same football players were included in both the study group and the control group. There was a 72-hour break between the interventions for the study group and the control group. The study began with the study group. The study group received Flossband application while the control group received foam roller bandage application. The same exercises were conducted alongside both interventions. Measurements were taken before and after the interventions and exercises. Ankle dorsiflexion range of motion was evaluated using the weight-bearing lunge test, static balance using a smartphone application, dynamic balance using the Y-balance test, and proprioception using the joint position sense test. Additionally, the hop test was used to assess jumping performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flossband Group | Active comparator | Other: FlossbandOur study began by applying flossband to the football players. The players were first assessed without the flossband, and then reassessed with the flossband to measure its effectiveness. This group was referred to as the 'Study Group.' |
| Controlled Group | Sham comparator | Other: Controlled GroupAfter the specified rest period, the football players were evaluated prior to the foam roller application. Seventy-two hours later, they were reassessed with the foam roller to measure the effectiveness of the application. This group was referred to as the 'Control Group. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged between 18 and 25 years old.
- Engaged in regular football training for at least 3 years.
Key exclusion criteria (5 listed)
- History of fractures and surgeries in the lower extremities.
- Diagnosed with other ankle and lower extremity problems.
- Presence of pain in the ankle and lower extremities.
- Systemic conditions such as deep vein thrombosis and embolism.
- Experience of pain during any measurement.
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 |
|---|---|---|
| FlossbandThe use of Flossband (Sanctband COMPRE Floss 5.1 cm × 3.5 m; Sanct Japan Co., Ltd.), made of natural rubber, was applied starting from 5 cm below the ankle joint line with a 50% stretch. The band tension was increased to 70-75% around 2 cm above the attachment point of the Achilles tendon. | Other | Flossband Group |
| Controlled GroupAlso: ShamCramer Tape Underwrap (7cm X 27m) foam bandage was applied starting 5 cm below the ankle joint line without tension. The control group received the same exercise protocol as the study group. | Other | Controlled Group |
Primary outcome
Weight Bearing Lunge Test
Time frame: 3 days
The ankle dorsiflexion range of motion was evaluated. Three tests were conducted for each participant, and the best score was recorded. Each assessment was performed before and after taping.
Static Balance Assesment
Time frame: 3 days
using the 'Accelerometer' application developed with Apple iPhone 14 and Dream Arc App Inventor, the static balance of football players was measured. Participants were instructed to stand on one leg for 30 seconds. Three trials were conducted, and the best score was recorded. The application recorded acceleration data in three axes (x, y, z) at a sampling rate of 20 Hz during the 30-second duration. Higher acceleration values indicated poorer balance.
Dynamic Balance Test
Time frame: 3 days
The Y balance test is a dynamic assessment widely used among athletes, requiring strength, flexibility, and proprioception, with good reliability. For the test, three equal-length strips of tape are placed on the floor to form a Y shape with angles of 90°, 135°, and 135° between them. The foot to be tested is placed at the intersection of the tapes, and the athlete is instructed to reach as far as possible in three different directions (anterior, posterolateral, posteromedial) while maintaining balance with the other foot. Football players attempted to reach maximum distance in each of these three directions, and these distances were recorded. The highest score from three successful reaches in each direction was normalized relative to leg length.Each assessment was performed before and after taping.
Proprioseptive Evaluation
Time frame: 3 days.
When evaluating joint position sense, the football player was seated on a chair with their feet flat on the ground and eyes closed. Using a smartphone goniometer application, the range of motion of both ankles was measured. The tested ankle was passively moved into a dorsiflexion position of 10 degrees and then returned to its original position. The player was asked to actively replicate the same position with their foot, and the deviation from the target 10 degrees was recorded. This process was repeated three times, and the average deviation was calculated.Each assessment was performed before and after taping
Triple Hop Test
Time frame: 3 days
This is a commonly used test for evaluating the functional abilities of the ankle and knee joints. The test measures the participant's balance, performance, and joint stability. A 6-meter scale is prepared, and the football player is instructed to stand on the assessed foot with arms by the sides and knees bent at a 45-degree angle in the starting position. The player is asked to perform three maximal forward jumps and land on the same line with the foot used for jumping. The distance between the heel and the starting point is measured, and the longest of two attempts is recorded.Each assessment was performed before and after taping
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 10 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Ankle Instability
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
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 Flossband in people with Ankle Instability, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 10 Jul 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Weight Bearing Lunge Test (time frame: 3 days). The study lists 5 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 10 Jul 2024.