Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain

Plantar Fascitis Clinical Trial

Official title:

Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423900
• Other study ID #: YeditepeFTR
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2020
• Source: Yeditepe University
• Contact: Elif Tugçe Çil, M.S.c
• Phone: 05544811092
• Email: tugce.cill[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Fasciitis
• Fasciitis, Plantar
• Feet Pes Cavus
• Feet Pes Planus (Flatfoot)
• Flatfoot
• Foot Diseases
• Plantar Fascitis
• Tendinopathy

Intervention

Diagnostic Test:
• smart phone application
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.

Locations

Country	Name	City	State
Turkey	Elif Tugçe Çil	Istanbul	Europe

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Victorian Institute of Sport Assessment-Achilles Questionnaire	The VISA-A aims to evaluate the clinical severity of patients with chronic Achilles tendinopathy. It can be used to determine the patient's clinical severity and provide a guideline for treatments as well as for monitoring the effect of treatment. Robinson et al. designed the Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire, as a region-specific functional questionnaire, to assess the severity of AT.6 It contains eight questions that cover the three domains of pain (questions 1-3), function (questions 5-7) and activity (questions 7 and 8). Scores are summed to give a total out of 100. An asymptomatic person would score 100. It has proven to be a valid and reliable instrument to measure disability in cross-cultural studies conducted in Turkey	8 weeks
Other	Foot Function Index	FFI assessed pain, activity restriction, and disability. The pain subscale, which includes nine items, measures foot pain related to a variety of conditions. Various functional activities depending on foot problems were determined by the disability subscale, which also includes nine items. Activity restrictions due to foot problems were assessed with an activity limitation subscale containing five items. Higher scores indicate more pain, disability, and limited activity. In our study, the patients were asked to mark each category with a score between 0 and 10 about their pain, activity restriction, and disability level. All the categorized scores were collected, and a total score was noted.	8 weeks
Primary	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.	8 weeks
Primary	the Range of Motion of the ankle	Physiotherapist will measure the Range of Motion of the ankle by using Goniometer	8 weeks
Primary	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.	8 weeks
Secondary	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	8 weeks