Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus

• ClinicalTrials.gov Identifier: NCT06037746
• Recruitment Status: Completed
• First Posted: September 14, 2023
• Last Update Posted: September 18, 2023
• Sponsor: Istanbul Gelisim University
• Information provided by (Responsible Party): Istanbul Gelisim University

Tracking Information

• First Submitted Date: September 7, 2023
• First Posted Date: September 14, 2023
• Last Update Posted Date: September 18, 2023
• Actual Study Start Date: March 25, 2022
• Actual Primary Completion Date: December 25, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2023)

• Static Balance Test [ Time Frame: Baseline and after immediately after intervention ]
  The static balance level of individuals was measured with the Flamingo Balance Test, a valid and reliable instrument. It was recorded how many times the individual fell or broke the test while trying to balance on one leg for 1 minute on a 15 cm long, 4 cm wide wooden plate. During this period, each time the test was stopped, the timer was also stopped, and the timer was restarted after the individual repositioned. The test was repeated 3 times, and the average value was recorded.
• Dynamic Balance Test [ Time Frame: Baseline and after immediately after intervention ]
  The dynamic balance level of individuals was measured with the "Y" Balance Test, a valid and reliable instrument, and their dominant extremities were evaluated. While trying to balance on one foot at the midpoint of the assembly, the individual was asked to reach forward with the other foot in the anterior, posteromedial, and posterolateral directions and touch the tip of the toe. The test was repeated 3 times in each direction, and the average value was recorded.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus
• Official Title: Immediate Effects of Myofascial Release Techniques on Balance in Young Adults With Pes Planus: A Single Blind, Randomized Controlled Pilot Study
• Brief Summary: The plantar fascia is a thick, multi-layered, non-elastic fibrous tissue band that extends along the plantar surface of the foot.The configuration of the plantar fascia is generally considered as a dense, longitudinally arranged fiber band divided into medial, central, and lateral components. The most significant functional role of the plantar fascia is to maintain the arch structure of the foot, providing a stable support base while standing and absorbing dynamic reaction forces during walking.Pes planus is a rather general term with many definitions. Staheli described pes planus as a "foot with a broad base of support," commonly known as flatfoot in layman's terms. In a study involving 80 female participants aged 65 and older, 90% of foot deformities observed while standing were identified as pes planus. Generally, pes planus is a condition characterized by excessive pronation of the rear part of the foot and a lowering of the medial longitudinal arch. During the push-off phase of walking, the pronation moment generated by the ground reaction force flattens the arch as the subtalar joint rotation combines. The shift in position in the talus bone causes the navicular bone to drop. The plantar calcaneonavicular ligament tightens, and the tibialis posterior muscle lengthens. Abnormalities in the bones of the foot, dysfunction of the tibialis posterior muscle, Achilles tendon shortening, or muscle weakness can contribute to pes planus. Individuals with pes planus may experience foot and leg pain with exercise, physical activity, and prolonged walking, which can limit their level of physical activity. Research has examined the relationship between pes planus and various physical parameters, and it has been found that one of these parameters, balance, is negatively affected by the presence of pes planus.
• Detailed Description: Participant information, including age, gender, height, body weight, and body mass index, was recorded using a general form. Dynamic and static balance was assessed before and after the interventions in the study groups. Three specialist physiotherapists conducted measurements and evaluations (navicular drop, static and dynamic balance). The assessing physiotherapist remained consistent throughout, and they were unaware of the participant groups. An expert in manual therapy administered the MRTs. Statistical analysis was performed by a separate researcher uninvolved in the practical aspects of the study.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Flat Foot

Intervention

• Other: Graston
  For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 10 minutes in the longitudinal, vertical and oblique directions.
• Other: Percussive massage
  For the application, the individual was asked to lie face down, flex the knee to 90 degrees and release the ankle. The therapist took a position next to the individual on the side to be treated. Application was applied to the entire plantar fascia for 5 minutes in all directions without being bound to a single direction.

Study Arms

• Experimental: Graston Group
  Miyofascial release was performed by graston tool on the entire plantar fascia.
  Intervention: Other: Graston
• Experimental: Percussive Massage Group
  Miyofascial release was performed by theragun tool on the entire plantar fascia.
  Intervention: Other: Percussive massage
• No Intervention: Control Group
  No application has been made.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 7, 2023): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 25, 2023
• Actual Primary Completion Date: December 25, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• volunteering for study participation,
• being between the ages of 18-25
• presence of pes planus.

Exclusion Criteria:

• Presence of orthopedic conditions other than pes planus,
• having a history of lower extremity surgery
• presence of neurological or rheumatological disorders,
• having a problem with vision or hearing
• participating in regular physical activity (>150 min/week)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06037746
• Other Study ID Numbers: PP001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: It is not yet known if there will be a plan to make IPD available.

• Current Responsible Party: Istanbul Gelisim University
• Original Responsible Party: Same as current
• Current Study Sponsor: Istanbul Gelisim University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Istanbul Gelisim University
• Verification Date: September 2023