NCT04695561

Brief Summary

The aim of the study is to investigate the effects of foam roller and instrument assisted soft tissue mobilization on pain, functionality and performance in athletes with iliotibial band tightness

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

First Submitted

Initial submission to the registry

November 19, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 18, 2021

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 19, 2020

Last Update Submit

March 16, 2021

Conditions

Keywords

Fascia LataFasciaMassageMusculoskeletal Manipulations

Outcome Measures

Primary Outcomes (9)

  • Change from baseline in Isokinetic Strength at 6 weeks

    It is a very effective force work since the muscles are dynamically loaded at their maximum capacity at all points of the angle of motion during isokinetic contraction. In our study, hip flexor-extensor, hip abductor-adductor, knee flexor-extensor muscle strength will be evaluated with the humac norm 2004 cybex isokinetic device.

    [Baseline and 6 weeks]

  • Change from baseline in Pain Threshold Score at 6 weeks

    Pressure pain threshold is expressed as the lowest pressure giving pain or discomfort. "J Tech Commander Algometer" will be used to evaluate the pain threshold in our study. The device is a digital pain threshold measuring device and 1 cm. It consists of a sensor connected to a diameter hard tip. Pain in individuals with iliotibial band tension is 3 cm above the femur lateral condyle. The participant will be asked to stop the measurement by warning the therapist as soon as the pressure turns into a painful feeling. the minimum values mean worse outcome the maximum values mean better outcome

    [Baseline and 6 weeks]

  • Change from baseline in Vertical Jump Distance at 6 weeks

    Vertical jump test will be used to measure the lower extremity explosive power of the subjects. A digital Jump Meter will be used to measure the vertical jump distance of the subjects. Before the test, the subjects will be allowed enough trials to reach the maximal height. For the test, subjects will be asked to stand on the Jump Meter's mat. Subjects will be instructed to jump to the greatest possible distance with both feet, allowing their arms and feet to swing. After the splash, they should land on the mat as a double foot. The test will be repeated 3 times, a 1-minute rest interval will be given between tests and the best grade will be recorded in cm

    [Baseline and 6 weeks]

  • Change from baseline in Pro-Agility Test at 6 weeks

    The test called pro-agility will be used. At the starting point, the athlete will spread his legs, turn with the command to start and run fast to the right, touching the line 5 yards (4.6m) away with his right hand. The athlete will then turn left, quickly running to the ground 10 yards (9.1 m) away and touching the far line with his left hand. The athlete will turn back from the right and quickly run 5 yards between the start and the finish line, and the test will be completed.

    [Baseline and 6 weeks]

  • Change from baseline in Postural Control at 6 weeks

    Postural control performances of the athletes will be determined by the Balance Error Scoring System. The original name of the test is Balance Error Scoring System (BESS) and it has been translated into Turkish as Balance Error Scoring System. Test, subjects 20 sec. They are required to maintain their test positions under 6 different conditions, eyes closed and without any support: flat and foam surface and 3 separate stance positions (double leg, single leg and tandem). A gym floor will be used for the flat surface. For the foam surface, a medium density foam block of 50x41x6 cm will be used (Airex Balance Pad, Alcan Airex AG, CH-5643 Sins / Switzerland)

    [Baseline and 6 weeks]

  • Change from baseline in Modified Star Balance Test at 6 weeks

    Modified Star Balance Test is a method adapted from the Star Excursion Balance Test, which originally evaluated reaching in eight different directions, and is used in balance assessment. Extension directions were reduced to three as anterior, posteromedial and postero-lateral. The inter-rater and intra-rater reliability of Modified Star Balance Test was found to be quite high (95% CI: 0.88-0.99 p \<0.01)

    [Baseline and 6 weeks]

  • Change from baseline in Range of Motion (ROM) Assessment at 6 weeks

    ROM of the lower extremities will be evaluated with a goniometer.

    [Baseline and 6 weeks]

  • Change from baseline in Lower extremity functional scale (LEFS) at 6 weeks

    It is a patient-reported questionnaire that evaluates the functional status of patients with musculoskeletal dysfunction affecting their lower extremities. The questionnaire consists of 20 items; each item has five numerical response categories (0-4). The total score ranges from 0 to 80, and higher scores are considered to be better functional status. It has been shown to have a sensitive scale to detect changes in functional levels immediately after surgery.

    [Baseline and 6 weeks]

  • Change from baseline in OBER Test at 6 weeks

    The iliotibial tract consists of the fascia lata and the iliotibial band. The iliotibial band is formed by the thickening of the fascia lata lateral to the thigh. The Ober test is used to evaluate Tensor Fascia Lata and iliotibial band tightness. The patient lies in the supine position with the hips and knees extended. The untested leg is brought to abduction, the other leg is moved next to the leg in abduction (hyperadduction). If the Tensor Fascia Lata is short, the leg tested does not go into hyperadduction. In the study conducted by Ferber et al. (2010) regarding the Ober test and iliotibial band flexibility measurements, 300 participants were evaluated with the inclinometer and the average was found to be 24.59 degrees

    [Baseline and 6 weeks]

Study Arms (3)

Self Myofascial Relaxation

EXPERIMENTAL

In addition to the exercises applied to the participants in the control group, the participants in this group used Foam Roller, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks.

Other: Self Myofascial Relaxation

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

In addition to the exercises applied to the participants in the control group, the participants in this group used Instrument Assisted Soft Tissue Mobilization, which was performed with the principle of painless movement 2 times a week for a total of 12 times a week for 6 weeks.

Other: Instrument Assisted Soft Tissue Mobilization

Only Exercise (Control)

ACTIVE COMPARATOR

Stretching and strengthening exercises for the hip flexors, hip extensors and iliotibial band were shown to the participants in the control group for 6 weeks every day of the week.

Other: Only Exercise (Control)

Interventions

Total of 12 times for 6 weeks

Self Myofascial Relaxation

Total of 12 times for 6 weeks

Instrument Assisted Soft Tissue Mobilization

Every day for 6 weeks

Only Exercise (Control)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The leg inclinations of the athletes evaluated with the Ober test will be measured with an inclinometer and the athletes below 25 degrees will be included in the study.
  • Age between 18 and 30 years
  • Agree to participate in the study,

You may not qualify if:

  • Not having surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayram Sönmez Ünüvar

Konya, 42250, Turkey (Türkiye)

Location

Study Officials

  • Ertuğrul Demirdel

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

January 5, 2021

Study Start

November 23, 2020

Primary Completion

March 14, 2021

Study Completion

March 15, 2021

Last Updated

March 18, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations