StretchNCT06370741
Effect of Stretching Exercises on Plantar Fascia
A study testing Stretching with/without device in people with Stretch and Plantar Fascia; Contracture, run by Okan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stretch, Plantar Fascia; Contracture, Fasciitis, Plantar
- What is being tested?
- Stretching with/without device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers over 18 years of age with a body mass index below 30 kg/m²
Who cannot join
- 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
About this study
Official title: Investigation of the Effectiveness of Achilles and Plantar Fascia-specific Stretching Methods on Plantar Fascia Mechanical Properties in Healthy Subjects: A Pilot Study
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.
Read the detailed description
The intricate network of connective tissues in the foot, including the plantar aponeurosis (PA) originating from the calcaneus, sets the stage for a comprehensive understanding of conditions like plantar fasciitis. This broad and thick band runs longitudinally, forming distinct components crucial for maintaining the arch's integrity. Complementing this structure is the plantar fascia (PF), intricately connected to the superficial and deep muscles of the sole, creating a myofascial continuum with profound implications for foot biomechanics.
The interplay between the plantar fascia, Achilles tendon, and the Plantar Aponeurosis within the triceps surae complex emphasizes their collective role as the main extensor and propulsion system of the foot. The posterior compartment of the lower leg, housing various muscles, further underscores the complexity of this biomechanical system.
Nonoperative interventions, constituting approximately 90% effectiveness, encompass a range of approaches, including stretching exercises, modalities, and shock wave therapy, among others. Notably, 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.
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.
In the light of all this information, 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.
- Conditions
- Stretch, Plantar Fascia; Contracture, Fasciitis, Plantar
- Being tested
- Stretching with/without device
- Medical subject headings
- Contracture, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching with/without deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Stretching with/without device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Before treatment/ Immediately after the first stretching exercise/ At the end of the second week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StretchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Surenkok, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370741
- Sponsor's protocol ID
- OkanUni.
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Achilles and Plantar Fascia-specific Stretching Methods on Plantar Fascia Mechanical Properties in Healthy Subjects: A Pilot Study
- ClinicalTrials.gov ID
- NCT06370741
- Acronym / sponsor ID
- OkanUni.
- Conditions
- Stretch, Plantar Fascia; Contracture, Fasciitis, Plantar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The intricate network of connective tissues in the foot, including the plantar aponeurosis (PA) originating from the calcaneus, sets the stage for a comprehensive understanding of conditions like plantar fasciitis. This broad and thick band runs longitudinally, forming distinct components crucial for maintaining the arch's integrity. Complementing this structure is the plantar fascia (PF), intricately connected to the superficial and deep muscles of the sole, creating a myofascial continuum with profound implications for foot biomechanics.
The interplay between the plantar fascia, Achilles tendon, and the Plantar Aponeurosis within the triceps surae complex emphasizes their collective role as the main extensor and propulsion system of the foot. The posterior compartment of the lower leg, housing various muscles, further underscores the complexity of this biomechanical system.
Nonoperative interventions, constituting approximately 90% effectiveness, encompass a range of approaches, including stretching exercises, modalities, and shock wave therapy, among others. Notably, 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.
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.
In the light of all this information, 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Achilles tendon stretching | Experimental | Device: Stretching with/without deviceParticipants 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. |
| Plantar fascia specific stretching | Active comparator | Device: Stretching with/without deviceA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers over 18 years of age with a body mass index below 30 kg/m²
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretching with/without deviceParticipants 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. | Device | Achilles tendon stretching, Plantar fascia specific stretching |
Primary outcome
Plantar Fascia Mechanical Properties
Time frame: Before treatment/ Immediately after the first stretching exercise/ At the end of the second week
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching with/without device in people with Stretch and Plantar Fascia; Contracture, run by Okan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar Fascia Mechanical Properties (time frame: Before treatment/ Immediately after the first stretching exercise/ At the end of the second week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.