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

NCT04423900 | Unknown

• 1 other identifier: YeditepeFTR
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• the Range of Motion of the ankle

  Physiotherapist will measure the Range of Motion of the ankle by using Goniometer

  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.

  8 weeks

Secondary Outcomes (1)

• Tampa Scale for Kinesiophobia

  8 weeks

Other Outcomes (2)

• The Victorian Institute of Sport Assessment-Achilles Questionnaire

  8 weeks

• Foot Function Index

  8 weeks

Study Arms (6)

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.

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.

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.

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.

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.

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.

Diagnostic Test: smart phone application

Interventions

smart phone application DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain in the heel and surrounding area
• Have given consent to be a volunteer for participating to the study
• years and older
• Ability to use a smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Elif Tuğçe Çil

Istanbul, Europe, 34755, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Talipes Cavus; Clubfoot; Foot Diseases; Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Fasciitis

Central Study Contacts

Elif Tuğçe Çil, M.S.c

CONTACT

05544811092; tugce.cill@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

TU (1)