Parkinson DiseaseNCT05187195
The Effects of Tele-rehabilitation Interventions in Parkinson's Patients
A study testing Home-based telerehabilitation with exercise videos and Exercise brochure in people with Parkinson Disease, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD) is the most common neurodegenerative movement disorder. The main motor symptoms of PD are tremor, rigidity, bradykinesia, and postural instability. Current treatments of the disease provide control of motor symptoms but do not change its development. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Home-based telerehabilitation with exercise videos and Exercise brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Nov 2021to 17 Feb 2023
- 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
- Having been diagnosed with Parkinson's disease at least 1 year ago by a neurologist
- Hoehn and Yahr score ≤3
- Have an internet infrastructure where the system can be accessed at home
- Not participating in a standardized physiotherapy program in the last 3 months
Who cannot join
- Presence of blurred or low vision problems
- Hearing and speech impairment affecting 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
İstanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
About this study
Official title: The Effects of Two Different Tele-rehabilitation Interventions on Physical Parameters and Activities of Daily Living in People With Parkinson's Disease
Parkinson's Disease (PD) is the most common neurodegenerative movement disorder. The main motor symptoms of PD are tremor, rigidity, bradykinesia, and postural instability. Current treatments of the disease provide control of motor symptoms but do not change its development. Parkinson's patients should receive regular rehabilitation as part of their treatment. Telerehabilitation (TR) practices and studies examining the effectiveness of these practices are needed in order to reduce the impact of the current pandemic period and environmental and personal causes in accessing rehabilitation services.
In this thesis, in order to examine the effects of two different TR methods on physical parameters and activities of daily living in Parkinson's patients, Parkinson's patients who are eligible the inclusion criteria will be randomized according to the row of application and divided into 2 groups. Evaluations to determine the functionality, activities of daily living, falling activity, quality of life and fatigue level will be applied both groups. One group will be applied video exercise program prepared individually via TR system, and the other group will receive an exercise brochure via the TR system and patients will be asked to do the exercises 3 days a week for 8 weeks. Then the initial evaluations will be repeated. 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 with exercise training to be applied to people with Parkinson's.
Read more
Investigators think that present study not only will contribute to the field of TR applications in PD, but also will provide access to rehabilitation services and help control symptoms of Parkinson's patients who cannot go to hospital, rehabilitation centers and cannot access rehabilitation services at home.
Hypotheses:
H0-TR applications have no effect on the level of independence in physical parameters and activities of daily living in individuals with PD.
H1-TR applications have positive effects on physical parameters and independence in activities of daily living in individuals with PD.
- Conditions
- Parkinson Disease
- Being tested
- Home-based telerehabilitation with exercise videos, Exercise brochure
- Keywords
- Telerehabilitation, Physical Therapy Modalities, Nervous System Diseases, Home-based, Physiotherapy
- Medical subject headings
- Parkinson Disease, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based telerehabilitation with exercise videosOther
Balance, walking, strengthening, posture 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, posture 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-video group | Experimental | This group will perform their exercises with prepared personalized exercise videos through the telerehabilitation system 3 days a week for 8 weeks. Receives: Other: Home-based telerehabilitation with exercise videos |
| Telerehabilitation-brochure group | Experimental | This group will perform exercises with personalized exercise brochures defined through the telerehabilitation system 3 days 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 - SLS (The change between the initial value and 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. In Parkinson's disease, standing for less than 10 seconds is associated with balance problems and the risk of falling. Standing for a long time indicates better function. The test maintains for a maximum of 1 minute.
Measured: Baseline and end of weeks 8
Five Times Sit to Stance Test - 5XSST (The change between the initial value and 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 time is recorded. Lasting longer than 16 seconds is associated with the risk of falling in Parkinson's patients. Completing the movement in less time indicates better function.
Measured: Baseline and end of weeks 8
Romberg Test - RT (The change between the initial value and 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. If the patient cannot stand with his eyes closed, the test is considered positive, and if the patient can stand with his eyes closed, the test is considered negative. The test is continued for a maximum of 60 seconds. Being able to stand longer indicates better function.
Measured: Baseline and end of weeks 8
Independent Standing Test (The change between the initial value and 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. The patient is expected to be able to stand for 20 seconds. Being able to stand longer indicates better function.
Measured: Baseline and end of weeks 8
Katz Index of Independence in Activities on Daily Living (The change between the initial value and 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. The patient can get a minimum of 0 points and a maximum of 7 points. Higher score indicates better status.
Measured: Baseline and end of weeks 8
Secondary outcomes (5)
Modified Falls Efficacy Scale (The change between the initial value and value after 2 months will be evaluated)
It is a 14-item scale that measures the patient's confidence in falling. The patient can get a minimum of 0 points and a maximum of 140 points. Higher score indicates better status.
Measured: Baseline and end of weeks 8
The World Health Organization Quality of Life Instrument, Short Form, Turkish Version (WHOQOL-BREF-TR) (The change between the initial value and 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 Turkish version of the scale in addition to the original version. Each item on the 26-item scale should be evaluated on its own. Scoring is made from 1 to 5. In some questions, 1 indicates a positive situation, while in some questions 5 indicates positive thoughts.
Measured: Baseline and end of weeks 8
Fatigue Severity Scale (The change between the initial value and 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. The patient can get a minimum of 9 points and a maximum of 63 points. A lower score indicates better status.
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. The patient can get a minimum of -5 and a maximum of 5 points. Higher score indicates better status.
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. Each item on the 10-item scale should be evaluated on its own. Scoring is made from 1 to 5. In some questions, 1 indicates a positive situation, while in some questions 5 indicates positive thoughts.
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 posted11 Jan 2022
- Study start14 Nov 2021
- Primary completion18 Nov 2022
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yılmaz, Istanbul University - Cerrahpasa
- Investigators
- Elif Yılmaz, 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
- NCT05187195
- Sponsor's protocol ID
- IUC-2021/48
- Status last verified
- Apr 2023
- First submitted
- 24 Dec 2021
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Tele-rehabilitation Interventions on Physical Parameters and Activities of Daily Living in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05187195
- Acronym / sponsor ID
- IUC-2021/48
- Conditions
- Parkinson Disease
- Keywords
- Telerehabilitation, Physical Therapy Modalities, Nervous System Diseases, Home-based, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 14 Nov 2021 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 11 Jan 2022 (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.
Parkinson's Disease (PD) is the most common neurodegenerative movement disorder. The main motor symptoms of PD are tremor, rigidity, bradykinesia, and postural instability. Current treatments of the disease provide control of motor symptoms but do not change its development. Parkinson's patients should receive regular rehabilitation as part of their treatment. Telerehabilitation (TR) practices and studies examining the effectiveness of these practices are needed in order to reduce the impact of the current pandemic period and environmental and personal causes in accessing rehabilitation services.
In this thesis, in order to examine the effects of two different TR methods on physical parameters and activities of daily living in Parkinson's patients, Parkinson's patients who are eligible the inclusion criteria will be randomized according to the row of application and divided into 2 groups. Evaluations to determine the functionality, activities of daily living, falling activity, quality of life and fatigue level will be applied both groups. One group will be applied video exercise program prepared individually via TR system, and the other group will receive an exercise brochure via the TR system and patients will be asked to do the exercises 3 days a week for 8 weeks. Then the initial evaluations will be repeated. 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 with exercise training to be applied to people with Parkinson's.
Investigators think that present study not only will contribute to the field of TR applications in PD, but also will provide access to rehabilitation services and help control symptoms of Parkinson's patients who cannot go to hospital, rehabilitation centers and cannot access rehabilitation services at home.
Hypotheses:
H0-TR applications have no effect on the level of independence in physical parameters and activities of daily living in individuals with PD.
H1-TR applications have positive effects on physical parameters and independence in activities of daily living in individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation-video group | Experimental | Other: Home-based telerehabilitation with exercise videosThis group will perform their exercises with prepared personalized exercise videos through the telerehabilitation system 3 days a week for 8 weeks. |
| Telerehabilitation-brochure group | Experimental | Other: Exercise brochureThis group will perform exercises with personalized exercise brochures defined through the telerehabilitation system 3 days 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)
- Having been diagnosed with Parkinson's disease at least 1 year ago by a neurologist
- Hoehn and Yahr score ≤3
- Have an internet infrastructure where the system can be accessed at home
- Not participating in a standardized physiotherapy program in the last 3 months
Key exclusion criteria (5 listed)
- Presence of blurred or low vision problems
- Hearing and speech impairment affecting 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 telerehabilitation with exercise videosBalance, walking, strengthening, posture 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-video group |
| Exercise brochurePhotos and explanations of exercises taken in different positions such as balance, walking, strengthening, posture 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 | Telerehabilitation-brochure group |
Primary outcome
Single Leg Stance Test - SLS (The change between the initial value and 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. In Parkinson's disease, standing for less than 10 seconds is associated with balance problems and the risk of falling. Standing for a long time indicates better function. The test maintains for a maximum of 1 minute.
Five Times Sit to Stance Test - 5XSST (The change between the initial value and 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 time is recorded. Lasting longer than 16 seconds is associated with the risk of falling in Parkinson's patients. Completing the movement in less time indicates better function.
Romberg Test - RT (The change between the initial value and 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. If the patient cannot stand with his eyes closed, the test is considered positive, and if the patient can stand with his eyes closed, the test is considered negative. The test is continued for a maximum of 60 seconds. Being able to stand longer indicates better function.
Independent Standing Test (The change between the initial value and 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. The patient is expected to be able to stand for 20 seconds. Being able to stand longer indicates better function.
Katz Index of Independence in Activities on Daily Living (The change between the initial value and 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. The patient can get a minimum of 0 points and a maximum of 7 points. Higher score indicates better status.
5 secondary outcomes
Modified Falls Efficacy Scale (The change between the initial value and value after 2 months will be evaluated)
Time frame: Baseline and end of weeks 8
The World Health Organization Quality of Life Instrument, Short Form, Turkish Version (WHOQOL-BREF-TR) (The change between the initial value and 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 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Elif Yılmaz, 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 with exercise videos and Exercise brochure in people with Parkinson Disease, 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: finished, as of the sponsor's last update on 12 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Leg Stance Test - SLS (The change between the initial value and 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 12 Apr 2023.