NCT06491277

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

June 24, 2024

Last Update Submit

July 9, 2024

Conditions

Keywords

physical Functional performanceFloosbandBandage

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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

    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

    3 days

Study Arms (2)

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.'

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.

Other: Controlled Group

Interventions

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.

Flossband Group

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.

Also known as: Sham
Controlled Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFootball Players who plays in the man football team.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 25 years old.
  • Engaged in regular football training for at least 3 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat Üniversity

Antalya, Alanya, 07450, Turkey (Türkiye)

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, Physiotherapist,Thesis Advisor

Study Record Dates

First Submitted

June 24, 2024

First Posted

July 9, 2024

Study Start

December 1, 2023

Primary Completion

March 31, 2024

Study Completion

May 24, 2024

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations