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Tele-Rehabilitation in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Tele Rehabilitation, Parkinson's Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Istanbul Rumeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
Static Standing Balance Test
Individuals were asked to stand in different positions and their static balance was assessed.
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."
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.
Beck Anxiety Inventory
Assesses anxiety level. Min:0 Max:63 "high score is bad score."
The Beck Depression Inventory
Assesses the level of depression. Min:0 Max: 63 "high score is bad score."
ACTIVLIM Scale
It is a questionnaire that measures the activity limitation of individuals. Min: 0 Max:36 "high score is good score."
Standardized Mini Mental Test
Evaluates the cognitive level of the person

Secondary Outcome Measures

Full Information

First Posted
May 9, 2021
Last Updated
May 24, 2022
Sponsor
Hacettepe University
Collaborators
BElibol, NKöse, GYÇakmaklı
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1. Study Identification

Unique Protocol Identification Number
NCT04982887
Brief Title
Tele-Rehabilitation in Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
BElibol, NKöse, GYÇakmaklı

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Tele Rehabilitation, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Exercise (Servical Stabilization exercises and conventional exercise)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
baseline to 6 week after
Title
Numeric Analog Scale
Description
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.
Time Frame
baseline to 6 week after
Title
30 - Second Chair Stand Test
Description
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.
Time Frame
baseline to 6 week after
Title
Static Standing Balance Test
Description
Individuals were asked to stand in different positions and their static balance was assessed.
Time Frame
baseline to 6 week after
Title
The Fear of Covid-19 Scale
Description
It is a test that measures individual's Covid-19 fears. Min:7 Max:35 "high score is bad score."
Time Frame
baseline to 6 week after
Title
Short-Form 36
Description
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.
Time Frame
baseline to 6 week after
Title
Beck Anxiety Inventory
Description
Assesses anxiety level. Min:0 Max:63 "high score is bad score."
Time Frame
baseline to 6 week after
Title
The Beck Depression Inventory
Description
Assesses the level of depression. Min:0 Max: 63 "high score is bad score."
Time Frame
baseline to 6 week after
Title
ACTIVLIM Scale
Description
It is a questionnaire that measures the activity limitation of individuals. Min: 0 Max:36 "high score is good score."
Time Frame
baseline to 6 week after
Title
Standardized Mini Mental Test
Description
Evaluates the cognitive level of the person
Time Frame
baseline to 6 week after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozden BASKAN
Organizational Affiliation
Istanbul Rumeli University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Rumeli University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
Citation
Bennett SE, Karnes JL. Neurological Disabilities. Assessment and Treatment. 1 st ed. Lippincott: Philadelphia; 1998.
Results Reference
background
PubMed Identifier
21514890
Citation
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.
Results Reference
background
PubMed Identifier
18344392
Citation
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.
Results Reference
background
PubMed Identifier
17509884
Citation
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.
Results Reference
background
PubMed Identifier
8866492
Citation
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.
Results Reference
background

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Tele-Rehabilitation in Parkinson's Disease

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