Achilles TendinopathyNCT04423900
Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
A study testing smart phone application in people with Achilles Tendinopathy and Plantar Fascitis, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy, Plantar Fascitis, Feet Pes Cavus
- What is being tested?
- smart phone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 30 Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in the heel and surrounding area
- Have given consent to be a volunteer for participating to the study
- 18 years and older
- Ability to use a smartphone
Who cannot join
- Having foot and ankle injury and surgery in the last three months
- Have received physiotherapy or local injection before randomization
- Having major pathologies during the rehabilitation program (severe heart and neuropsychiatric disorders, complicated diabetes mellitus)
- Neoplastic formation in the foot-ankle region
- Vision problem
- Night pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Elif Tuğçe Çil
Istanbul, Europe, 34755
ELİF TUĞÇE ÇİL, M.S.c, 05544811092, tugce.cill@gmail.com
Feryal Subaşı, Professor
About this study
This randomized controlled study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications. Additionally, to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.
Read the detailed description
Foot pain is common in the general population, with prevalence estimates ranging from 17 to 30% . A systematic review concluded that nearly one-quarter of adults over age 45 experience frequent foot pain. Foot pain has been associated with poor balance, gait problems, the limitation of daily living activities, and health-related quality of life. It has been reported that at least two-thirds of individuals experience moderate functional daily life problems .The etiology of hindfoot pain is mostly associated with Achilles Tendinopathy and Plantar Fasciitis, which are prevalent, affecting millions of people each year . Most cases of hindfoot pain if not treated, they will get worse with time and resistant symptoms. This is why to get more information on prevalence and risk factors in the general population is necessary to organize health care planning and the extent of clinical need.An increase in the use of digital technology and smart phones globally with mobile applications provide an alternative solution to the planning of primary health care services. In the US, approximately 90% of adults have a mobile phone, and 58% of these prefer smart phones, while in Turkey, 98% of adults use mobile phones, and 77% of them are smart phones owners. The popularity of smart phones provides opportunities for reaching information and giving skills to users through applications. These applications offer new opportunities for collecting, evaluating, and monitoring health information and have portability, the flexibility of use, and a width of the access area.With the concept of this approaching (using digital technologies,) several systematic reviews have examined digital programs using for different health conditions/ pathologies (paralysis, lack of balance/stabilization, cardiac disorders, and joint / extremity). A great deal of physiotherapy interventions for hindfoot pain includes electrotherapy agents, 'hands-on' therapy, stretching, and strengthening exercises. The exercise programs are an essential part of rehabilitation programs for hindfoot pain, and patients who involved in this exercise program also need to get feedback by physiotherapist. For this reason, the digital technology-based applications are considered to be contributive for follow-up exercise regularly and detecting the changes and progression. Additionally, to the best of our knowledge, a smartphone application research involving hindfoot pathology with suggesting assessment methods and including exercise program is not available in the literature. Thereby, the study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications and to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.
- Conditions
- Achilles Tendinopathy, Plantar Fascitis, Feet Pes Cavus, Feet Pes Planus (Flatfoot), Foot Diseases
- Being tested
- smart phone application
- Keywords
- telerehabilitation, hind foot pain, plantar fasciitis, achilles tendinopathy, smart phone
- Medical subject headings
- Talipes Cavus, Clubfoot, Foot Diseases, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart phone applicationDiagnostic test
Participants will be asked to provide information about their sociodemographic characteristics, chronic diseases, the history of the ankle injury, trauma, and surgery, the severity of the foot pain via using the mobile application.The app will be downloaded from the Google Play Store and available offline. Information from the patient will be stored in an SQLite database.The usability test will be carried out on the mobile application so that the latest releases contain clear, effective, loyal to the strategy, and easily understood messages by the intended audience and do not produce unwanted responses.Direct observation, individual interviews, and satisfaction surveys will be used to identify areas of improvement in a cross-sectional manner.Investigation of pes cavus, pes planus and ankle range of motion will be determined by image processing.All data can be analyzed and stored by Heel Analysis Systems established on an external server.The data will be transferred securely over HTTPS.
| Study group | Role | What they receive |
|---|---|---|
| Plantar Fasciitis App Exercise Group | Experimental | Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks. Receives: Diagnostic Test: smart phone application |
| Achilles Tendinopathy App Exercise Group | Experimental | Video simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks. Receives: Diagnostic Test: smart phone application |
| Plantar Fasciitis Home Exercise Group | Experimental | Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks. Receives: Diagnostic Test: smart phone application |
| Achilles Tendinopathy Home Exercise Group | Experimental | Patients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks. Receives: Diagnostic Test: smart phone application |
| Plantar Fasciitis Conventional Physiotherapy Group | Experimental | In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks. Receives: Diagnostic Test: smart phone application |
| Achilles Tendinopathy Conventional Physiotherapy Group | Experimental | In this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks. Receives: Diagnostic Test: smart phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feiss Line test
Feiss Line is an ankle examination procedure that tests for pes planus, flatfoot, fallen medial longitundinal arch.Patient should be standing with weight distributed evenly.
The examiner uses a marker to mark the inferior apex of medial malleolus and medial surface of the base of the base of the 1st metatarsal.
The examiner draws a line connecting the two points. The examiner locates the the navicular tuberosity and marks it.
Measured: 8 weeks
the Range of Motion of the ankle
Physiotherapist will measure the Range of Motion of the ankle by using Goniometer
Measured: 8 weeks
Visual Analog Scale - Pain Assesment
Visual Analogue Scale (VAS) was used to estimate the severity of participants' first step (morning time) and activity pain. It consists of a line, usually 100 mm long, whose ends are labeled as the extremes (no pain and worst pain imaginable); the rest of the line is blank.
Measured: 8 weeks
Secondary outcomes (1)
Tampa Scale for Kinesiophobia
Tampa consists of 17 questions and is used in diseases associated with acute and chronic low back pain, fibromyalgia, and musculoskeletal injuries. The scale uses a 4-point Likert score (1 = Strongly disagree, 4 = Strongly agree). A total score is calculated after the reversal of items 4, 8, 12, and 16. The patients can have a total score of between 17-68. The higher the score indicates, the higher the kinesiophobia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One hundred twenty patients aged 18-75 years, diagnosed as Plantar fasciitis and Achilles Tendinopathy by an Orthopedic surgeon, will be included. Patients will be randomly divided into three groups according to inclusion criteria.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423900
- Sponsor's protocol ID
- YeditepeFTR
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
- ClinicalTrials.gov ID
- NCT04423900
- Acronym / sponsor ID
- YeditepeFTR
- Conditions
- Achilles Tendinopathy, Plantar Fascitis, Feet Pes Cavus, Feet Pes Planus (Flatfoot), Foot Diseases
- Keywords
- telerehabilitation, hind foot pain, plantar fasciitis, achilles tendinopathy, smart phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 9 Jun 2020 (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.
This randomized controlled study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications. Additionally, to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.
Detailed description
Foot pain is common in the general population, with prevalence estimates ranging from 17 to 30% . A systematic review concluded that nearly one-quarter of adults over age 45 experience frequent foot pain. Foot pain has been associated with poor balance, gait problems, the limitation of daily living activities, and health-related quality of life. It has been reported that at least two-thirds of individuals experience moderate functional daily life problems .The etiology of hindfoot pain is mostly associated with Achilles Tendinopathy and Plantar Fasciitis, which are prevalent, affecting millions of people each year . Most cases of hindfoot pain if not treated, they will get worse with time and resistant symptoms. This is why to get more information on prevalence and risk factors in the general population is necessary to organize health care planning and the extent of clinical need.An increase in the use of digital technology and smart phones globally with mobile applications provide an alternative solution to the planning of primary health care services. In the US, approximately 90% of adults have a mobile phone, and 58% of these prefer smart phones, while in Turkey, 98% of adults use mobile phones, and 77% of them are smart phones owners. The popularity of smart phones provides opportunities for reaching information and giving skills to users through applications. These applications offer new opportunities for collecting, evaluating, and monitoring health information and have portability, the flexibility of use, and a width of the access area.With the concept of this approaching (using digital technologies,) several systematic reviews have examined digital programs using for different health conditions/ pathologies (paralysis, lack of balance/stabilization, cardiac disorders, and joint / extremity). A great deal of physiotherapy interventions for hindfoot pain includes electrotherapy agents, 'hands-on' therapy, stretching, and strengthening exercises. The exercise programs are an essential part of rehabilitation programs for hindfoot pain, and patients who involved in this exercise program also need to get feedback by physiotherapist. For this reason, the digital technology-based applications are considered to be contributive for follow-up exercise regularly and detecting the changes and progression. Additionally, to the best of our knowledge, a smartphone application research involving hindfoot pathology with suggesting assessment methods and including exercise program is not available in the literature. Thereby, the study aims to evaluate the status of the individuals with hindfoot pain and to recommend preventive precautions and appropriate exercise programs with Smart Phone-Based Applications and to compare the results of patients who attended through mobile applications (Achilles Tendinopathy and Plantar Fasciitis) with the results of patients included in the hands-on program.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- One hundred twenty patients aged 18-75 years, diagnosed as Plantar fasciitis and Achilles Tendinopathy by an Orthopedic surgeon, will be included. Patients will be randomly divided into three groups according to inclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Plantar Fasciitis App Exercise Group | Experimental | Diagnostic Test: smart phone applicationVideo simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks. |
| Achilles Tendinopathy App Exercise Group | Experimental | Diagnostic Test: smart phone applicationVideo simulation of patient education (definition of the disease, risk factors, lifestyle modifications, prevention methods) will be performed to people via smart phone app application. Individuals will receive feedback after completing the training program and will then be included in the exercise program. The mobile application provides feedback so that the exercise program (stretching, strengthening, self-myofascial relaxation exercises) determined according to the diagnosis of the patients is performed by the patients at twice a day for eight weeks. |
| Plantar Fasciitis Home Exercise Group | Experimental | Diagnostic Test: smart phone applicationPatients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks. |
| Achilles Tendinopathy Home Exercise Group | Experimental | Diagnostic Test: smart phone applicationPatients will learn the exercises by the physiotherapist in the clinic. Patients will be included in the training program (stretching, strengthening, self-myofascial release exercises) -only once. Then, patients will do this program at their home twice a day for eight weeks. |
| Plantar Fasciitis Conventional Physiotherapy Group | Experimental | Diagnostic Test: smart phone applicationIn this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks. |
| Achilles Tendinopathy Conventional Physiotherapy Group | Experimental | Diagnostic Test: smart phone applicationIn this group, patients will first be included in the patient education and exercises program in the clinic-only once. Mulligan Concept - Manual Therapy and Compressive myofascial relaxation methods will be applied to the individuals who have completed the patient training program by the physiotherapist. Patients will participate in the rehabilitation program twice a week for eight weeks. These patients will perform their home exercises twice daily and for eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain in the heel and surrounding area
- Have given consent to be a volunteer for participating to the study
- 18 years and older
- Ability to use a smartphone
Key exclusion criteria (6 listed)
- Having foot and ankle injury and surgery in the last three months
- Have received physiotherapy or local injection before randomization
- Having major pathologies during the rehabilitation program (severe heart and neuropsychiatric disorders, complicated diabetes mellitus)
- Neoplastic formation in the foot-ankle region
- Vision problem
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 |
|---|---|---|
| smart phone applicationParticipants will be asked to provide information about their sociodemographic characteristics, chronic diseases, the history of the ankle injury, trauma, and surgery, the severity of the foot pain via using the mobile application.The app will be downloaded from the Google Play Store and available offline. Information from the patient will be stored in an SQLite database.The usability test will be carried out on the mobile application so that the latest releases contain clear, effective, loyal to the strategy, and easily understood messages by the intended audience and do not produce unwanted responses.Direct observation, individual interviews, and satisfaction surveys will be used to identify areas of improvement in a cross-sectional manner.Investigation of pes cavus, pes planus and ankle range of motion will be determined by image processing.All data can be analyzed and stored by Heel Analysis Systems established on an external server.The data will be transferred securely over HTTPS. | Diagnostic test | Achilles Tendinopathy App Exercise Group, Achilles Tendinopathy Conventional Physiotherapy Group, Achilles Tendinopathy Home Exercise Group, Plantar Fasciitis App Exercise Group, Plantar Fasciitis Conventional Physiotherapy Group, Plantar Fasciitis Home Exercise Group |
Primary outcome
Feiss Line test
Time frame: 8 weeks
Feiss Line is an ankle examination procedure that tests for pes planus, flatfoot, fallen medial longitundinal arch.Patient should be standing with weight distributed evenly. The examiner uses a marker to mark the inferior apex of medial malleolus and medial surface of the base of the base of the 1st metatarsal. The examiner draws a line connecting the two points. The examiner locates the the navicular tuberosity and marks it.
the Range of Motion of the ankle
Time frame: 8 weeks
Physiotherapist will measure the Range of Motion of the ankle by using Goniometer
Visual Analog Scale - Pain Assesment
Time frame: 8 weeks
Visual Analogue Scale (VAS) was used to estimate the severity of participants' first step (morning time) and activity pain. It consists of a line, usually 100 mm long, whose ends are labeled as the extremes (no pain and worst pain imaginable); the rest of the line is blank.
1 secondary outcome
Tampa Scale for Kinesiophobia
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Achilles Tendinopathy
Not yet recruitingObservational study
Open Versus Fully Endoscopic Calcaneoplasty With Achilles Tendon Insertional Reconstruction for Haglund Syndrome
Haglund Syndrome, Insertional Achilles Tendinopathy
Recruiting
Single-Row Versus Double-Row Repair for Achilles Insertional Tendinopathy
Achilles Insertional Tendinopathy, Achilles Tendinopathy
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
Not yet recruitingObservational study
Human Tendon Tissue Collection
Tendinopathy, Musculoskeletal Diseases or Conditions
Not yet recruiting
Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
Achilles Injuries Tendon, Achilles Tendinopathy (AT)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart phone application in people with Achilles Tendinopathy and Plantar Fascitis, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Elif Tuğçe Çil, M.S.c (05544811092, tugce.cill@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feiss Line test (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 11 Jun 2020.