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Development and Application of Tele-Neuro Rehabilitation System

Primary Purpose

Stroke, Multiple Sclerosis, Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitaton
Home Exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring E-Health, Web Based Systems, Neurologic Rehabilitation, Neurorehabilitation, Physical Therapy and Rehabilitation, Stroke Rehabilitation, Multiple Sclerosis, Parkinson's Disease, Data Storage, Stroke

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Other

Experimental

Other

Experimental

Other

Arm Label

Stroke (Telerehabilitation)

Stroke (Home Exercise)

Multiple Sclerosis (Telerehabilitation)

Multiple Sclerosis (Home Exercise)

Parkinson Disease (Telerehabilitation)

Parkinson Disease (Home Exercise)

Arm Description

Exercise therapy with telerehabilitation system

Exercise therapy with brochure

Exercise therapy with telerehabilitation system

Exercise therapy with brochure

Exercise therapy with telerehabilitation system

Exercise therapy with brochure

Outcomes

Primary Outcome Measures

Independent Standing Test (The change between the initial value and the value after 2 months will be evaluated).
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.
Romberg Test (The change between the initial value and the value after 2 months will be evaluated).
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.
One-Legged Standing Test (The change between the initial value and the value after 2 months will be evaluated).
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.
5 Times Sit and Stand Test (The change between the initial value and the value after 2 months will be evaluated).
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.
KATZ Independence Index in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated).
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

Modified Fall Efficiency Scale (The change between the initial value and the value after 2 months will be evaluated).
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.
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).
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.
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated).
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.
System Usability Scale (The change between the initial value and the value after 2 months will be evaluated).
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.
Global Change Scale (The change between the initial value and the value after 2 months will be evaluated).
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).

Full Information

First Posted
July 5, 2021
Last Updated
August 26, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
The Scientific and Technological Research Council of Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05031403
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
The Scientific and Technological Research Council of Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke (Telerehabilitation)
Arm Type
Experimental
Arm Description
Exercise therapy with telerehabilitation system
Arm Title
Stroke (Home Exercise)
Arm Type
Other
Arm Description
Exercise therapy with brochure
Arm Title
Multiple Sclerosis (Telerehabilitation)
Arm Type
Experimental
Arm Description
Exercise therapy with telerehabilitation system
Arm Title
Multiple Sclerosis (Home Exercise)
Arm Type
Other
Arm Description
Exercise therapy with brochure
Arm Title
Parkinson Disease (Telerehabilitation)
Arm Type
Experimental
Arm Description
Exercise therapy with telerehabilitation system
Arm Title
Parkinson Disease (Home Exercise)
Arm Type
Other
Arm Description
Exercise therapy with brochure
Intervention Type
Other
Intervention Name(s)
Telerehabilitaton
Intervention Description
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
Intervention Name(s)
Home Exercise
Intervention Description
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 Measure Information:
Title
Independent Standing Test (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
Romberg Test (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
One-Legged Standing Test (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
5 Times Sit and Stand Test (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
KATZ Independence Index in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Secondary Outcome Measure Information:
Title
Modified Fall Efficiency Scale (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
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).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
System Usability Scale (The change between the initial value and the value after 2 months will be evaluated).
Description
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.
Time Frame
Baseline and end of weeks 8.
Title
Global Change Scale (The change between the initial value and the value after 2 months will be evaluated).
Description
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).
Time Frame
Baseline and end of weeks 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonca Zenginler Yazgan, Asst. Prof.
Phone
+905344245350
Email
yoncazenginler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ela Tarakcı, Prof.
Organizational Affiliation
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof
Organizational Affiliation
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Murat Kürtüncü, MD
Organizational Affiliation
Istanbul University-Capa Faculty of Medicine, Department of Neurology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Muhammed Erdem İsenkul, Asst. Prof.
Organizational Affiliation
Istanbul University-Cerrahpaşa Faculty of Engineering
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pelin Vural
Organizational Affiliation
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Recep Örmen
Organizational Affiliation
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonca Zenginler Yazgan
Email
yoncazenginler@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Development and Application of Tele-Neuro Rehabilitation System

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