Parkinson DiseaseNCT04982887
Tele-Rehabilitation in Parkinson's Disease
A study testing Exercise in people with Parkinson Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease (PD) is a neurodegenerative disease that occurs with the effect of dopaminergic pathways in the substantia nigra and causes a progressive decrease in motor functions. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2021to 20 Apr 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with Parkinson's Disease who came to Hacettepe University between December 2018 and July 2019 were included in the thesis study.
- Individuals who received physiotherapy training two years ago will be contacted by phone and invited to study.
- On these dates, among the individuals selected within the scope of the thesis study, those who agree to participate in the study will be included in the study.
Who cannot join
- -Persons not meeting the above criteria were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Two Different Exercise Programs Adapted to the Tele Rehabilitation Program in Parkinson's Patients During the Covid 19 Pandemic Period
Parkinson's disease (PD) is a neurodegenerative disease that occurs with the effect of dopaminergic pathways in the substantia nigra and causes a progressive decrease in motor functions. When the literature is examined; Physiotherapy and rehabilitation programs applied in PD include conventional physiotherapy methods and neurophysiological based activity training. Classical physiotherapy programs; It includes stretching, strengthening, aerobics, posture exercises, balance and coordination training. PH treatment in recent years; Virtual reality is gradually enriched with motor imagery and robot-assisted physiotherapy applications and different exercise methods including dance, music therapy, yoga, pilates and spinal stabilization exercises.
Stabilization exercises, which form the basis of spinal stabilization training, use the basic principles of motor learning. The aim of the spinal stabilization exercise program is to support the vertebral column by increasing the strength and endurance of the stabilizer muscles, to improve the spinal posture by increasing kinesthetic awareness and to improve balance control.
Read more
The COVID-19 pandemic has highlighted the importance of telerehabilitation practices even more. Telerehabilitation can be defined as providing rehabilitation services remotely using information and communication technologies. In order to minimize the risk of transmission in the COVID-19 pandemic, physical activity levels of individuals have been reduced by restricting social life and the access of sick individuals to rehabilitation services is severely restricted. In addition, rehabilitation professionals are at risk in the treatment of these patients due to the serious transmission risk of COVID-19. Considering these situations, it is emphasized by many authorities that telerehabilitation practices should be expanded.
Inactivity, which occurs as a result of restrictions in access to social isolation and rehabilitation services, brought about by the COVID-19 Pandemic in Parkinson's patients, adversely affects the progression of the disease. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. It is known that telerehabilitation applied in various neurological diseases reduces the fatigue levels of the patients, improves their functional activities and quality of life.
In line with all these reasons, this study was planned to investigate the effectiveness of two different exercise programs adapted to the telerehabilitation program in Parkinson's patients during the Covid 19 pandemic.
- Conditions
- Parkinson Disease
- Being tested
- Exercise
- Keywords
- Tele Rehabilitation, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise (Servical Stabilization exercises and conventional exercise)
The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Exercise |
| Control Group | Experimental | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale
Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.
Measured: baseline to 6 week after
Numeric Analog Scale
Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. The participant is asked to say a value in this range according to the severity of pain.
Measured: baseline to 6 week after
30 - Second Chair Stand Test
It is used to assess individuals' lower extremity strength and static balance. the individual is asked to sit and stand in a chair for 30 seconds.
Measured: baseline to 6 week after
Static Standing Balance Test
Individuals were asked to stand in different positions and their static balance was assessed.
Measured: baseline to 6 week after
The Fear of Covid-19 Scale
It is a test that measures individual's Covid-19 fears. Min:7 Max:35 "high score is bad score."
Measured: baseline to 6 week after
Short-Form 36
SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.
Measured: baseline to 6 week after
Beck Anxiety Inventory
Assesses anxiety level. Min:0 Max:63 "high score is bad score."
Measured: baseline to 6 week after
The Beck Depression Inventory
Assesses the level of depression. Min:0 Max: 63 "high score is bad score."
Measured: baseline to 6 week after
ACTIVLIM Scale
It is a questionnaire that measures the activity limitation of individuals. Min: 0 Max:36 "high score is good score."
Measured: baseline to 6 week after
Standardized Mini Mental Test
Evaluates the cognitive level of the person
Measured: baseline to 6 week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start8 May 2021
- Primary completion25 Mar 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- BElibol, NKöse, GYÇakmaklı
- Responsible party
- Principal investigator, Emine Nur Demircan, Istanbul Rumeli University
- Investigators
- Ozden BASKAN, Study director, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982887
- Sponsor's protocol ID
- Tele-Rehabilitation
- Status last verified
- May 2022
- First submitted
- 9 May 2021
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bennett SE, Karnes JL. Neurological Disabilities. Assessment and Treatment. 1 st ed. Lippincott: Philadelphia; 1998.
Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.
PubMed 21514890Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
PubMed 18344392Vaugoyeau M, Viel S, Amblard B, Azulay JP, Assaiante C. Proprioceptive contribution of postural control as assessed from very slow oscillations of the support in healthy humans. Gait Posture. 2008 Feb;27(2):294-302. doi: 10.1016/j.gaitpost.2007.04.003. Epub 2007 May 16.
PubMed 17509884Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. doi: 10.1002/mds.870110506.
PubMed 8866492
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Two Different Exercise Programs Adapted to the Tele Rehabilitation Program in Parkinson's Patients During the Covid 19 Pandemic Period
- ClinicalTrials.gov ID
- NCT04982887
- Acronym / sponsor ID
- Tele-Rehabilitation
- Conditions
- Parkinson Disease
- Keywords
- Tele Rehabilitation, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- BElibol, NKöse, GYÇakmaklı
- Study start
- 8 May 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 29 Jul 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.
Parkinson's disease (PD) is a neurodegenerative disease that occurs with the effect of dopaminergic pathways in the substantia nigra and causes a progressive decrease in motor functions. When the literature is examined; Physiotherapy and rehabilitation programs applied in PD include conventional physiotherapy methods and neurophysiological based activity training. Classical physiotherapy programs; It includes stretching, strengthening, aerobics, posture exercises, balance and coordination training. PH treatment in recent years; Virtual reality is gradually enriched with motor imagery and robot-assisted physiotherapy applications and different exercise methods including dance, music therapy, yoga, pilates and spinal stabilization exercises.
Stabilization exercises, which form the basis of spinal stabilization training, use the basic principles of motor learning. The aim of the spinal stabilization exercise program is to support the vertebral column by increasing the strength and endurance of the stabilizer muscles, to improve the spinal posture by increasing kinesthetic awareness and to improve balance control.
The COVID-19 pandemic has highlighted the importance of telerehabilitation practices even more. Telerehabilitation can be defined as providing rehabilitation services remotely using information and communication technologies. In order to minimize the risk of transmission in the COVID-19 pandemic, physical activity levels of individuals have been reduced by restricting social life and the access of sick individuals to rehabilitation services is severely restricted. In addition, rehabilitation professionals are at risk in the treatment of these patients due to the serious transmission risk of COVID-19. Considering these situations, it is emphasized by many authorities that telerehabilitation practices should be expanded.
Inactivity, which occurs as a result of restrictions in access to social isolation and rehabilitation services, brought about by the COVID-19 Pandemic in Parkinson's patients, adversely affects the progression of the disease. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. It is known that telerehabilitation applied in various neurological diseases reduces the fatigue levels of the patients, improves their functional activities and quality of life.
In line with all these reasons, this study was planned to investigate the effectiveness of two different exercise programs adapted to the telerehabilitation program in Parkinson's patients during the Covid 19 pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Exercise |
| Control Group | Experimental | Other: Exercise |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with Parkinson's Disease who came to Hacettepe University between December 2018 and July 2019 were included in the thesis study.
- Individuals who received physiotherapy training two years ago will be contacted by phone and invited to study.
- On these dates, among the individuals selected within the scope of the thesis study, those who agree to participate in the study will be included in the study.
Key exclusion criteria (1 listed)
- -Persons not meeting the above criteria were excluded from the study.
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 |
|---|---|---|
| ExerciseAlso: Exercise (Servical Stabilization exercises and conventional exercise)The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems. | Other | Control Group, Experimental Group |
Primary outcome
Unified Parkinson's Disease Rating Scale
Time frame: baseline to 6 week after
Unified Parkinson's Disease Rating Scale. There are 4 sub-parameters. 1. mental status, behavior and mental state 2. daily life activities 3. motor inspection 4. treatment complications. mental status, behavior and mental state total 16 points, daily activity total 52 points, Motor parameter total 92 points, treatment complications total 23 points. Total maximum 183 points. the total score is calculated by adding all sub-parameter scores. low value is good, high value is a symptom of bad result.
Numeric Analog Scale
Time frame: baseline to 6 week after
Numerical rating scale of pain intensity. 0 to 10 is a scale with a rating. 0 points no pain 10 points is a scale with very severe pain. The participant is asked to say a value in this range according to the severity of pain.
30 - Second Chair Stand Test
Time frame: baseline to 6 week after
It is used to assess individuals' lower extremity strength and static balance. the individual is asked to sit and stand in a chair for 30 seconds.
Static Standing Balance Test
Time frame: baseline to 6 week after
Individuals were asked to stand in different positions and their static balance was assessed.
The Fear of Covid-19 Scale
Time frame: baseline to 6 week after
It is a test that measures individual's Covid-19 fears. Min:7 Max:35 "high score is bad score."
Short-Form 36
Time frame: baseline to 6 week after
SF-36 (Short Form 36). Quality of life survey. examines 8 dimensions of health with 36 items. physical function, social function, role restrictions, mental health, vitality, pain and general health. The scores of each parameter are between 0 and 100. 0 bad, 100 good results. is calculated by taking the values of the sub-parameters.
Beck Anxiety Inventory
Time frame: baseline to 6 week after
Assesses anxiety level. Min:0 Max:63 "high score is bad score."
The Beck Depression Inventory
Time frame: baseline to 6 week after
Assesses the level of depression. Min:0 Max: 63 "high score is bad score."
ACTIVLIM Scale
Time frame: baseline to 6 week after
It is a questionnaire that measures the activity limitation of individuals. Min: 0 Max:36 "high score is good score."
Standardized Mini Mental Test
Time frame: baseline to 6 week after
Evaluates the cognitive level of the person
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 27 May 2022.
- BackgroundBennett SE, Karnes JL. Neurological Disabilities. Assessment and Treatment. 1 st ed. Lippincott: Philadelphia; 1998.
- Background: PubMed 21514890Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.
- Background: PubMed 18344392Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- Background: PubMed 17509884Vaugoyeau M, Viel S, Amblard B, Azulay JP, Assaiante C. Proprioceptive contribution of postural control as assessed from very slow oscillations of the support in healthy humans. Gait Posture. 2008 Feb;27(2):294-302. doi: 10.1016/j.gaitpost.2007.04.003. Epub 2007 May 16.
- Background: PubMed 8866492Bloem BR, Beckley DJ, van Dijk JG, Zwinderman AH, Remler MP, Roos RA. Influence of dopaminergic medication on automatic postural responses and balance impairment in Parkinson's disease. Mov Disord. 1996 Sep;11(5):509-21. doi: 10.1002/mds.870110506.
- Individual participant dataSharing planned: Yes
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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.
Ozden BASKAN study director
Istanbul Rumeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease, run by Hacettepe University 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 3 inclusion and 1 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 27 May 2022. 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?
Unified Parkinson's Disease Rating Scale (time frame: baseline to 6 week after). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982887, which also lists 5 linked publications.
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 27 May 2022.