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Development and Application of Tele-Neuro Rehabilitation System

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ClinicalTrials.gov Identifier: NCT05031403
Recruitment Status : Recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
The Scientific and Technological Research Council of Turkey
Information provided by (Responsible Party):
Yonca Zenginler Yazgan, Istanbul University-Cerrahpasa

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.

Condition or disease Intervention/treatment Phase
Stroke Multiple Sclerosis Parkinson Disease Other: Telerehabilitaton Other: Home Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Application of Tele-Neuro Rehabilitation System: An Example of Digital Transformation in Health
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Stroke (Telerehabilitation)
Exercise therapy with telerehabilitation system
Other: 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.

Stroke (Home Exercise)
Exercise therapy with brochure
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.

Experimental: Multiple Sclerosis (Telerehabilitation)
Exercise therapy with telerehabilitation system
Other: 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.

Multiple Sclerosis (Home Exercise)
Exercise therapy with brochure
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.

Experimental: Parkinson Disease (Telerehabilitation)
Exercise therapy with telerehabilitation system
Other: 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.

Parkinson Disease (Home Exercise)
Exercise therapy with brochure
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.




Primary Outcome Measures :
  1. Independent Standing Test (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It tests the patient's ability to stand for 20 seconds in an upright position without any support or assistance, with her/his feet shoulder-width apart and arms free at the side of the body.

  2. Romberg Test (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    The patient is asked to stand in an upright position with his feet open at shoulder level, arms free at the side of the body, with eyes open and then closed, without losing his balance for 10 seconds before receiving any support. In case of excessive release or failure to continue the test, it is considered a Romberg positive or abnormal Romberg sign. It evaluates the effect of the patient's balance in the closed position.

  3. One-Legged Standing Test (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a functional evaluation test that measures the patient's one-leg standing balance. The patient is asked to raise one leg in the air and keep the knee bent at hip level for at least 10 seconds. Times less than 10 seconds indicate a balance disorder, and times less than 5 seconds indicate a risk of falling. It is applied with the patient's eyes open and closed.

  4. 5 Times Sit and Stand Test (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a test that evaluates functional lower extremity strength, transfer, balance and fall risk. The time for the patient to sit and stand up from the chair 5 times is recorded. It has been proven to be valid in patients with stroke, Parkinson's and Multiple Sclerosis.

  5. KATZ Independence Index in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a scale that measures the ability of the patient to do daily living activities independently and evaluates the functional status. It examines patient performances in six functions such as bathing, dressing, toilet, transfer, personal care and feeding. Patients score their activity independence in each of the six functions as 1 (independent) or 0 (dependent). A total score of 0 to 2 indicates severe dysfunction, a total score of 2 to 4 indicates moderate dysfunction, and a total score of 4 to 6 indicates full function.


Secondary Outcome Measures :
  1. Modified Fall Efficiency Scale (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a 14-item scale that measures the patient's confidence in falling. Each question is scored between 1-4. High scores indicate high fall anxiety.

  2. 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). [ Time Frame: Baseline and end of weeks 8. ]
    It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version. The scale measures physical, mental, social and environmental well-being and consists of a total of 27 questions with an additional question. Since each domain independently expresses the quality of life in its own field, field scores are calculated between 4-20. The higher the total score, the higher the quality of life.

  3. Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own. Each item is scored between 1 (strongly disagree) and 7 (strongly agree). The total score is calculated by taking the average of 9 items. A high score indicates increased fatigue severity.

  4. System Usability Scale (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems. It is scored from 1 (strongly disagree) to 5 (strongly agree). A high total score indicates that the system is detectable and usable.

  5. Global Change Scale (The change between the initial value and the value after 2 months will be evaluated). [ Time Frame: Baseline and end of weeks 8. ]
    It is a scale that evaluates how much a person's current situation has changed compared to his previous state. The person is asked to choose an exchange score from -5 (much worse than my previous state) to +5 (much better than my previous state).



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05031403


Contacts
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Contact: Yonca Zenginler Yazgan, Asst. Prof. +905344245350 yoncazenginler@gmail.com

Locations
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Turkey
Istanbul University-Cerrahpasa Recruiting
Istanbul, Turkey
Contact: Yonca Zenginler Yazgan       yoncazenginler@gmail.com   
Sponsors and Collaborators
Istanbul University-Cerrahpasa
The Scientific and Technological Research Council of Turkey
Investigators
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Study Chair: Ela Tarakcı, Prof. Istanbul University-Cerrahpaşa Faculty of Health Sciences
Study Chair: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof Istanbul University-Cerrahpaşa Faculty of Health Sciences
Study Chair: Murat Kürtüncü, MD Istanbul University-Capa Faculty of Medicine, Department of Neurology
Study Chair: Muhammed Erdem İsenkul, Asst. Prof. Istanbul University-Cerrahpaşa Faculty of Engineering
Study Chair: Pelin Vural Istanbul University-Cerrahpasa Institute of Postgraduate Education
Study Chair: Recep Örmen Istanbul University-Cerrahpasa Institute of Postgraduate Education
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Responsible Party: Yonca Zenginler Yazgan, Principal Investigator, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier: NCT05031403    
Other Study ID Numbers: 120S843
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonca Zenginler Yazgan, Istanbul University-Cerrahpasa:
E-Health
Web Based Systems
Neurologic Rehabilitation
Neurorehabilitation
Physical Therapy and Rehabilitation
Stroke Rehabilitation
Multiple Sclerosis
Parkinson's Disease
Data Storage
Stroke
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Sclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases