Development and Application of Tele-Neuro Rehabilitation System

NCT ID: NCT05031403

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-10-01

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.

Conditions

Stroke; Multiple Sclerosis; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stroke (Telerehabilitation)

Exercise therapy with telerehabilitation system

Group Type: EXPERIMENTAL

Telerehabilitaton

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.

Stroke (Home Exercise)

Exercise therapy with brochure

Group Type: OTHER

Home Exercise

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.

Multiple Sclerosis (Telerehabilitation)

Exercise therapy with telerehabilitation system

Group Type: EXPERIMENTAL

Telerehabilitaton

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.

Multiple Sclerosis (Home Exercise)

Exercise therapy with brochure

Group Type: OTHER

Home Exercise

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.

Parkinson Disease (Telerehabilitation)

Exercise therapy with telerehabilitation system

Group Type: EXPERIMENTAL

Telerehabilitaton

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.

Parkinson Disease (Home Exercise)

Exercise therapy with brochure

Group Type: OTHER

Home Exercise

Intervention Type: OTHER

Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.

Interventions

Telerehabilitaton

Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.

Intervention Type: OTHER

Home Exercise

Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Yonca Zenginler Yazgan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ela Tarakcı, Prof.

Role: STUDY_CHAIR

Istanbul University-Cerrahpaşa Faculty of Health Sciences

Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof

Role: STUDY_CHAIR

Istanbul University-Cerrahpaşa Faculty of Health Sciences

Murat Kürtüncü, MD

Role: STUDY_CHAIR

Istanbul University-Capa Faculty of Medicine, Department of Neurology

Muhammed Erdem İsenkul, Asst. Prof.

Role: STUDY_CHAIR

Istanbul University-Cerrahpaşa Faculty of Engineering

Pelin Vural

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Institute of Postgraduate Education

Recep Örmen

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Institute of Postgraduate Education

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Yonca Zenginler Yazgan, Asst. Prof.

Role: CONTACT

yoncazenginler@gmail.com

+905344245350

Facility Contacts

Yonca Zenginler Yazgan

Role: primary

yoncazenginler@gmail.com

Other Identifiers

120S843

Identifier Type: -

Identifier Source: org_study_id