StrokeNCT05031403
Development and Application of Tele-Neuro Rehabilitation System
A study testing Telerehabilitaton and Home Exercise in people with Stroke and Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Stroke, Multiple Sclerosis, Parkinson Disease
- What is being tested?
- Telerehabilitaton and Home Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Having pacemaker
- Presence of cardiac problems
- Presence of serious respiratory diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul
Yonca Zenginler Yazgan, yoncazenginler@gmail.com
About this study
Official title: Development and Application of Tele-Neuro Rehabilitation System: An Example of Digital Transformation in Health
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.
Read the 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
- Being tested
- Telerehabilitaton, Home Exercise
- Keywords
- E-Health, Web Based Systems, Neurologic Rehabilitation, Neurorehabilitation, Physical Therapy and Rehabilitation, Stroke Rehabilitation, Multiple Sclerosis, Parkinson's Disease, Data Storage, Stroke
- Medical subject headings
- Stroke, Multiple Sclerosis, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitatonOther
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.
Home ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke (Telerehabilitation) | Experimental | Exercise therapy with telerehabilitation system Receives: Other: Telerehabilitaton |
| Stroke (Home Exercise) | Other | Exercise therapy with brochure Receives: Other: Home Exercise |
| Multiple Sclerosis (Telerehabilitation) | Experimental | Exercise therapy with telerehabilitation system Receives: Other: Telerehabilitaton |
| Multiple Sclerosis (Home Exercise) | Other | Exercise therapy with brochure Receives: Other: Home Exercise |
| Parkinson Disease (Telerehabilitation) | Experimental | Exercise therapy with telerehabilitation system Receives: Other: Telerehabilitaton |
| Parkinson Disease (Home Exercise) | Other | Exercise therapy with brochure Receives: Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
Secondary outcomes (5)
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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.
Measured: Baseline and end of weeks 8.
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).
Measured: Baseline and end of weeks 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Apr 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Yonca Zenginler Yazgan, Istanbul University - Cerrahpasa
- Investigators
- Ela Tarakcı, Prof., Study chair, Istanbul University-Cerrahpaşa Faculty of Health SciencesBurcu Ersöz Hüseyinsinoğlu, Assoc. Prof, Study chair, Istanbul University-Cerrahpaşa Faculty of Health SciencesMurat Kürtüncü, MD, Study chair, Istanbul University-Capa Faculty of Medicine, Department of NeurologyMuhammed Erdem İsenkul, Asst. Prof., Study chair, Istanbul University-Cerrahpaşa Faculty of EngineeringPelin Vural, Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate EducationRecep Örmen, Study chair, Istanbul University-Cerrahpasa Institute of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031403
- Sponsor's protocol ID
- 120S843
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Tele-Neuro Rehabilitation System: An Example of Digital Transformation in Health
- ClinicalTrials.gov ID
- NCT05031403
- Acronym / sponsor ID
- 120S843
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stroke (Telerehabilitation) | Experimental | Other: TelerehabilitatonExercise therapy with telerehabilitation system |
| Stroke (Home Exercise) | Other | Other: Home ExerciseExercise therapy with brochure |
| Multiple Sclerosis (Telerehabilitation) | Experimental | Other: TelerehabilitatonExercise therapy with telerehabilitation system |
| Multiple Sclerosis (Home Exercise) | Other | Other: Home ExerciseExercise therapy with brochure |
| Parkinson Disease (Telerehabilitation) | Experimental | Other: TelerehabilitatonExercise therapy with telerehabilitation system |
| Parkinson Disease (Home Exercise) | Other | Other: Home ExerciseExercise therapy with brochure |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitatonPatients 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. | Other | Multiple Sclerosis (Telerehabilitation), Parkinson Disease (Telerehabilitation), Stroke (Telerehabilitation) |
| Home ExercisePatients 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. | Other | Multiple Sclerosis (Home Exercise), Parkinson Disease (Home Exercise), Stroke (Home Exercise) |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ela Tarakcı, Prof. study chair
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof study chair
Istanbul University-Cerrahpaşa Faculty of Health Sciences
Murat Kürtüncü, MD study chair
Istanbul University-Capa Faculty of Medicine, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitaton and Home Exercise in people with Stroke and Multiple Sclerosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonca Zenginler Yazgan, Asst. Prof. (+905344245350, yoncazenginler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.