StrokeNCT05083195
The Effect of Home-Based Telerehabilitation in Individuals With Stroke
A study testing Home-based Telerehabilitation and Exercise Brochure in people with Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Home-based Telerehabilitation and Exercise Brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2021to 28 Dec 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
- Diagnosed with stroke at least 1 year ago by a neurologist
- Modified Rankin score ≤3
- Have an internet infrastructure that can be accessed at home
- Not participated in a standardized physiotherapy program in the past 3 months
Who cannot join
- Presence of blurred or low vision problems
- Hearing and speech impairment at a level that will affect participation in the system
- Epilepsy
- Presence of pregnancy
- Having any cognitive problems that prevent using the system
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Bakirkoy, 34100
Recep Ormen, M.Sc, +905316777334, rormen@gmail.com
Yonca Zenginler Yazgan, PhD
About this study
Official title: The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke
Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.
In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.
- Conditions
- Stroke
- Being tested
- Home-based Telerehabilitation, Exercise Brochure
- Keywords
- Telerehabilitation, Home-based, Physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based TelerehabilitationOther
Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
Exercise BrochureOther
Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Group | Experimental | This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks. Receives: Other: Home-based Telerehabilitation |
| Control Group | Experimental | This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks. Receives: Other: Exercise Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Measured: Baseline and end of weeks 8
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
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's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Measured: Baseline and end of weeks 8
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 in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Measured: Baseline and end of weeks 8
Katz Index of Independence 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 patient's ability to perform activities of daily living independently and evaluates the functional status.
Measured: Baseline and end of weeks 8
Secondary outcomes (5)
Modified Falls Efficacy 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.
Measured: Baseline and end of weeks 8
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.
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.
Measured: Baseline and end of weeks 8
Global Rating of Change Scales
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
Measured: End of weeks 8
System Usability Scale
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
Measured: 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 posted19 Oct 2021
- Study start4 Oct 2021
- Primary completion4 Aug 2022 (estimated)
- Study completion28 Dec 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Ormen, Istanbul University - Cerrahpasa
- Investigators
- Recep Ormen, M.Sc, Principal investigator, Istanbul University-Cerrahpasa Institute of Postgraduate EducationYonca Zenginler Yazgan, PhD, Study chair, Istanbul University-Cerrahpasa Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083195
- Sponsor's protocol ID
- IUC-2021/62
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05083195
- Acronym / sponsor ID
- IUC-2021/62
- Conditions
- Stroke
- Keywords
- Telerehabilitation, Home-based, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 4 Aug 2022 (estimated)
- Study completion
- 28 Dec 2022 (estimated)
- First posted
- 19 Oct 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.
Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.
In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Group | Experimental | Other: Home-based TelerehabilitationThis group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks. |
| Control Group | Experimental | Other: Exercise BrochureThis group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with stroke at least 1 year ago by a neurologist
- Modified Rankin score ≤3
- Have an internet infrastructure that can be accessed at home
- Not participated in a standardized physiotherapy program in the past 3 months
Key exclusion criteria (5 listed)
- Presence of blurred or low vision problems
- Hearing and speech impairment at a level that will affect participation in the system
- Epilepsy
- 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 |
|---|---|---|
| Home-based TelerehabilitationBalance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system. | Other | Telerehabilitation Group |
| Exercise BrochurePhotos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure. | Other | Control Group |
Primary outcome
Single Leg Stance 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 assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Five Times Sit to 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
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
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's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
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 in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Katz Index of Independence 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 patient's ability to perform activities of daily living independently and evaluates the functional status.
5 secondary outcomes
Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
Time frame: Baseline and end of weeks 8
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
Global Rating of Change Scales
Time frame: End of weeks 8
System Usability Scale
Time frame: 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 19 Oct 2021.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Recep Ormen, M.Sc principal investigator
Istanbul University-Cerrahpasa Institute of Postgraduate Education
Yonca Zenginler Yazgan, PhD study chair
Istanbul University-Cerrahpasa Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Telerehabilitation and Exercise Brochure in people with Stroke, 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 4 inclusion and 5 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 19 Oct 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 Recep Ormen, M.Sc (+905316777334, rormen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Leg Stance 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 19 Oct 2021.