Clinical trial NCT04423900: Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
Official title: Smart Phone-Based Application for Evaluation and Rehabilitation of HindFoot Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feiss Line test
timeFrame: 8 weeks
measure: the Range of Motion of the ankle
timeFrame: 8 weeks
measure: Visual Analog Scale - Pain Assesment
timeFrame: 8 weeks
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia
timeFrame: 8 weeks
Other outcomes:
measure: The Victorian Institute of Sport Assessment-Achilles Questionnaire
timeFrame: 8 weeks
measure: Foot Function Index
timeFrame: 8 weeks
Locations:
city: İstanbul
country: Turkey
facility: Elif Tuğçe Çil
state: Europe
Study officials:
References: