Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique in Individuals With Asymptomatic Dynamic Knee Valgus

NCT04660604 | Completed DMC FDA Device

• 1 other identifier: IASTM-24.11.20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY DESIGN: Randomized controlled study OBJECTIVES: To investigate the contribution of instrument assisted soft tissue mobilization (IASTM) applied to gluteus medius (GMed) to isokinetic strength, femoral internal rotation (FIR), frontal plan projection angle (FPPA) and postural stability (PS) in individuals with asymptomatic dynamic knee valgus (DDV). BACKGROUND: In the literature effect of IASTM on force production and performance has been examined with exercise, and results of the studies are contradictory. Studies investigating the effects of IASTM without exercise and at recommended dose are needed. METHODS: 44 participants with DDV (21,39±1,79) were randomized to be control group (CG=22) and graston group (GG=22). First day, participants' FIR, FPPA with single leg squat test, dynamic and static PS on involved leg evaluations were completed. Second day, eccentric strength of GMed was measured by isokinetic test. IASTM application was applied 6 weeks, twice a week, 5 minutes, using Graston Technique® instruments. CG has not been attempted. Evaluations were repeated at the end of treatment.

Conditions

Dynamic Knee Valgus; Force Production; Frontal Plan Projection Angle; Instrument-assisted Soft Tissue Mobilization; Postural Stability

Outcome Measures

Primary Outcomes (1)

• Change in isokinetic strength measurement

  gluteus medius eccentric strength evaluated with Cybex® Norm isokinetic dynamometer

  Pre evaluation before the intervention, 1 day after the intervention

Secondary Outcomes (3)

• Change in postural stability evaluation

  Pre evaluation before the intervention, 1 day after the intervention

• Change in Femoral internal rotation angle evaluation

  Pre evaluation before the intervention, 1 day after the intervention

• Change in frontal plan projection angle evaluation

  Pre evaluation before the intervention, 1 day after the intervention

Study Arms (2)

Graston Technique® Group

EXPERIMENTAL

Participants were asked to warm up at a speed that they felt comfortable for 5 minutes at a gentle tempo with an ergometer. Time was followed by a stopwatch. Participants who completed warm-up were taken to GT® application. Application was implemented by a GT® certified therapist with 13 years of experience in orthopedic rehabilitation. Intervention dosage was determined as 2 times a week, 12 sessions over 6 weeks. GMed muscle was scanned between crista iliaca and trochanter major, and a fascial release was applied. Each session lasted 5 minutes. At the end of sessions, iliotibial band stretching exercises (30 seconds, 3 repetitions) was given to the treated side. Application protocol has been determined with reference to GT® manual

Device: Graston Technique®

Control Group

NO INTERVENTION

Control group is followed up for 6 weeks without intervention.

Interventions

Graston Technique® DEVICE

Graston technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.

Graston Technique® Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: recreationally active, healthy females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to be a female between ages of 18 and 35,
• to have an increase of more than 10 ° in FPPA in landing phase of single leg squat test (SLST),
• not to have pain complaints
• to be recreatively active.

You may not qualify if:

• body mass index of 30 kg/m² and above,
• to have previous lower extremity surgery and joint,
• meniscus or ligament injury,
• chronic knee instability,
• leg length inequality,
• joint degeneration detected by radiography,
• cardiac, musculoskeletal system, vestibular and neurological problems,
• using corticosteroids for a long time
• being pregnant.

Sponsors & Collaborators

• Bahçeşehir University: lead
• Medipol University: collaborator

Study Sites (1)

Pelin Pişirici

Istanbul, Besiktas/Istanbul, 34353, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not have the knowledge about what we are investigated and group types.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 9, 2020
• Study Start: June 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

TU (1)