- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04982887
Tele-Rehabilitation in Parkinson's Disease
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.
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul Rumeli University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-Persons not meeting the above criteria were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
|
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 Names:
|
Experimental: Control Group
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 6 week after
|
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.
|
baseline to 6 week after
|
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.
|
baseline to 6 week after
|
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.
|
baseline to 6 week after
|
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."
|
baseline to 6 week after
|
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.
|
baseline to 6 week after
|
Beck Anxiety Inventory
Time Frame: baseline to 6 week after
|
Assesses anxiety level.
Min:0 Max:63 "high score is bad score."
|
baseline to 6 week after
|
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."
|
baseline to 6 week after
|
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."
|
baseline to 6 week after
|
Standardized Mini Mental Test
Time Frame: baseline to 6 week after
|
Evaluates the cognitive level of the person
|
baseline to 6 week after
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ozden BASKAN, Istanbul Rumeli University
Publications and helpful links
General Publications
- Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045.
- 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.
- Bloem 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.
- Bennett SE, Karnes JL. Neurological Disabilities. Assessment and Treatment. 1 st ed. Lippincott: Philadelphia; 1998.
- Vaugoyeau 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TELE-REHABILITATION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown