Clinical trial NCT05031403: Development and Application of Tele-Neuro Rehabilitation System
Official title: Development and Application of Tele-Neuro Rehabilitation System: An Example of Digital Transformation in Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Parkinson Disease
Keywords: E-Health
Web Based Systems
Neurologic Rehabilitation
Neurorehabilitation
Physical Therapy and Rehabilitation
Stroke Rehabilitation
Multiple Sclerosis
Parkinson's Disease
Data Storage
Stroke
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2021-09-01
Enrollment: 114
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Disability due to neurological diseases is increasing in our country and world. With regular physiotherapy and rehabilitation, as well as patients' symptoms are brought under control, their affected functions in daily life are achieved and levels of independence and physical activity increase. Thus, the patients' quality of life and participation in social life is improved and patients are supported in physical, social and psychological terms. In recent years, it has been reported that exercise with telerehabilitation systems increase the compliance and participation of patients to the treatment, and even this system seems as effective as standard rehabilitation practices. Delivering the treatment through telerehabilitation system when that patients cannot receive it in the hospital due to epidemic, restriction, transfer difficulties, personal and environmental limitations will enable patients to receive the rehabilitation services.Telerehabilitation system is frequently encountered in the abroad, but there are limited systems with Turkish version specific to this patient group in our country. The aim of project is to develop and detect the efficiency of a telerehabilitation system which is used to assess, follow and design home-based rehabilitation program among individuals with chronic neurological diseases who have difficulty in participating in physiotherapy and rehabilitation services because of personal or environmental reasons.

Detailed description: The coding and design of this telerehabilitation system will enable easy access to all devices via the website. The expert interface of the system will consist of three interfaces; exercise videos to be prepared by physiotherapists will be uploaded, patient list and feedback of patients. Rehabilitation programs can be prepared and updated. There will be a panel in the patient interface that will allow the patient to access a rehabilitation program tailored to the problem and to communicate about the ongoing program when needed. In the manager interface, high-level control of many steps such as adding experts from different institutions, organizing information, creating an exercise pool will be provided. With the project, a telerehabilitation system will be put into practice, where patients can easily access the rehabilitation services from their homes, and patients can contact with clinicians when they need follow-up and treatment.

The patients and their caregivers will be informed about the system and project. In the assessment part, the physical performance will be determined. Also, questionnaires such as fall efficacy or activities of daily living will be requested through the system. Thus, a detailed assessment of the patient will be completed to reveal the problems. A rehabilitation program with appropriate exercises will be defined for patients in the telerehabilitation group and patients will be asked to apply this program three days a week for eight weeks. Patients in the control group will be placed on the waiting list after the first evaluations and no additional treatment will be applied by asking them to maintain their routine activity levels within this period. At the end of eight weeks, initial evaluations will be repeated in two groups.

This user-friendly telerehabilitation system with turkish language support will be the first comprehensive system that will let to assess, give exercise programs and follow the progression in patients with chronic neurologic disorders. With this system, the opportunity to reach more patients in the home environment will be provided. Rehabilitation programs will promote the physical capacity, health-related quality of life and it will also cause reducing in the burden of caregivers. After evaluating the applicability of our program, we will pave the way for the introduction of telerehabilitation care in health institutions and in areas with transportation issues, furthermore low-cost, sustainable system will be achieved to our country.

Eligibility criteria: Inclusion Criteria:

* Chronic patients diagnosed with neurological disease at least 1 year ago by a neurologist
* Multiple sclerosis patients with an Expanded Disability Status Scale (EDSS) score of ≤6, who are in the stable phase of the disease and have not had an attack in the last 3 months
* Parkinson's patients with a Hoehn and Yahr score ≤3
* Stroke patients with a modified Rankin score of ≤3
* To have an internet infrastructure where the system can be accessed at home
* Not participating in a standardized physiotherapy and rehabilitation program within the last 3 months
* Having a companion with the patient during the exercises

Exclusion Criteria:

* Presence of blurred or poor vision problems
* Hearing and speech impairment at a level that will affect participation in the system
* Epilepsy
* The presence of pregnancy
* Having any cognitive problems that prevent using the system
* History of trauma / fracture in the last 3-6 months
* Having pacemaker
* Presence of cardiac problems
* Presence of serious respiratory diseases

Primary outcomes:
measure: Independent Standing Test (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Romberg Test (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: One-Legged Standing Test (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: 5 Times Sit and Stand Test (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: KATZ Independence Index in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
Secondary outcomes:
measure: Modified Fall Efficiency Scale (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: World Health Organization Quality of Life Scale Short Form Turkish Version (WHOQOL-BREF-TR) (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: System Usability Scale (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
measure: Global Change Scale (The change between the initial value and the value after 2 months will be evaluated).
timeFrame: Baseline and end of weeks 8.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University-Cerrahpaşa Faculty of Health Sciences
name: Ela Tarakcı, Prof.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpaşa Faculty of Health Sciences
name: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof
role: STUDY_CHAIR
affiliation: Istanbul University-Capa Faculty of Medicine, Department of Neurology
name: Murat Kürtüncü, MD
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpaşa Faculty of Engineering
name: Muhammed Erdem İsenkul, Asst. Prof.
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Pelin Vural
role: STUDY_CHAIR
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Recep Örmen
role: STUDY_CHAIR
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