NCT06370741

Brief Summary

The plantar fascia (PF) extends over the calcaneal bone with a thin band corresponding to the calcaneal periosteum, continuing as the paratenon of the Achilles tendon.The triceps surae complex, serving as the main extensor and propulsion system of the foot, involves the Achilles tendon, posterior part of the calcaneus, and Plantar Aponeurosis, all integrated with the fibrous skeleton of the triceps surae. Plantar fasciitis, a prevalent musculoskeletal condition affecting individuals of various ages and activity levels (Hye Chang Rhim), is a primary cause of heel pain in adults. Studies have identified the superior efficacy of stretching protocols targeting the Achilles tendon and/or plantar fascia compared to alternative treatments. However, the limitations of traditional approaches become apparent when considering the intricate biomechanics of the foot and ankle. Conventional calf stretches often prove inadequate for addressing its specific lengthening requirements. While contemporary methods like PF-Specific Stretching integrate plantar fascia and calf stretches, their reliance on individual upper extremity strength introduces potential limitations. Therefore, although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be aimed to determine whether an instrument aid to be designed will have an effect and which method is more effective. In this way, it is planned to guide clinicians in the rehabilitation of possible pathologies specific to the plantar fascia in clinical practice. Myotonometry is a convenient method to assess the stiffness of the plantar fascia because it is cheap, simple and fast. Previous studies have shown that MyotonPRO can reliably assess the stiffness of the plantar fascia. Although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be determined whether stretching with an instrument to be designed will have an effect and which method is more effective with or without an instrument.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

April 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 5, 2024

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plantar Fascia Mechanical Properties

    MyotonPRO, an objective assessment method, will be used to evaluate the mechanical properties of the plantar fascia such as tone, stiffness and elasticity. MyotonPRO is a portable palpation device designed to assess the tone and biomechanical properties of muscle, tendon and fascia. This allows simultaneous calculation of the mechanical properties of the fascia: tonus - tension (frequency; Hz), stiffness - intramuscular resistance (N/m) and elasticity (characterized by decrement - logarithmic decrease)

    Before treatment/ Immediately after the first stretching exercise/ At the end of the second week

Study Arms (2)

Achilles tendon stretching

EXPERIMENTAL

Participants in this group will use a stretching device designed to stretch the dominant side Achilles tendon. With the help of this tool, the fingers will be positioned in extension and the other leg will be placed in front with the dominant side leg at the back. The knee of the other leg will be bent forward while the back knee is kept straight with the heel firmly on the ground. The toes of the evaluated foot will point to the heel of the front foot. For the non-dominant side, the same stretching exercise will be performed without equipment.

Device: Stretching with/without device

Plantar fascia specific stretching

ACTIVE COMPARATOR

A special stretching protocol known as PFSS (Plantar Fascia-Specific Stretching) will be applied. The method will be performed by placing the non-dominant leg over the opposite leg in a seated position. Following this, participants will apply force distal to the metatarsophalangeal joints in the assessed foot and pull the toes upwards towards the proximal side until a visible stretch is felt in the plantar fascia. Participants in this group will use the stretching device designed for their dominant side. The method will be performed by placing the toes on the bar of the device in the extension position and moving the knee forward so that the foot is in the dorsiflexion position without lifting the heel off the ground.

Device: Stretching with/without device

Interventions

Participants will be divided into two groups: Achilles tendon stretching and plantar fascia specific stretching. Within these two groups, participants will stretch their dominant side with the help of the designed tool. On the non-dominant side, the Achilles tendon group will complete the Achilles tendon stretching without a tool and the plantar fascia-specific stretching group will complete the self plantar fascia stretching exercise. Each stretching exercise will be performed for 10 seconds and 10 repetitions 3 days a week for 2 weeks.

Achilles tendon stretchingPlantar fascia specific stretching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers over 18 years of age with a body mass index below 30 kg/m²

You may not qualify if:

  • pregnancy, presence of chronic musculoskeletal diseases, presence of lower extremity injury and/or surgery, presence of skin lesions above the measurement sites and use of medications affecting the musculoskeletal system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ContractureFasciitis, Plantar

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular DiseasesFasciitisFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 17, 2024

Study Start

April 1, 2024

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04