NCT06037746

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

March 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 7, 2023

Last Update Submit

September 14, 2023

Conditions

Keywords

Pes PlanusMyofascial ReleasePostural BalanceRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • Static Balance Test

    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.

    Baseline and after immediately after intervention

  • Dynamic Balance Test

    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.

    Baseline and after immediately after intervention

Study Arms (3)

Graston Group

EXPERIMENTAL

Miyofascial release was performed by graston tool on the entire plantar fascia.

Other: Graston

Percussive Massage Group

EXPERIMENTAL

Miyofascial release was performed by theragun tool on the entire plantar fascia.

Other: Percussive massage

Control Group

NO INTERVENTION

No application has been made.

Interventions

GrastonOTHER

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.

Graston Group

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.

Percussive Massage Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Gelisim University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

March 25, 2022

Primary Completion

December 25, 2022

Study Completion

March 25, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations