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The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients

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ClinicalTrials.gov Identifier: NCT04694872
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 6, 2021
Sponsor:
Collaborator:
Istanbul University-Cerrahpasa
Information provided by (Responsible Party):
Guzin Kaya Aytutuldu, Yeditepe University

Brief Summary:
It is planned to recruit 30 individuals with Parkinson's Disease within the scope of the study. Balance, gait, activity transfers of Parkinson's Patients will be evaluated. The study will be randomly divided into two groups. In the first group, an exercise protocol called LSVT BIG will be applied via the Zoom application with mobile phone, tablet or computer for 4 days a week for 4 weeks. This exercise protocol consists of reliable movements suitable for the conditions of patients with large amplitudes. For the other group, balance and functional mobility exercises will be applied via the Zoom application with mobile phone, tablet or computer for 4 weeks, 4 days a week. Balance, walking and activity transfer measurements will be repeated at the end of a total of 4 weeks. It is planned to include 30 patients with a diagnosis of Parkinson's Disease (PD) with a level of 1-3 according to the Hoehn-Yahr scale, who applied to the Neurology Clinic of the Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurology Training and Research Hospital. The volunteers who will participate in the study will be informed about the purpose of the study, its duration, and the possible side effects of the treatment to be applied. Primary outcome measures include Mini Best Test, Biodex balance evaluation and Kinovea for gait assessment. Dynamic balance will be evaluated with Mini-Best Test, postural stability and fall risk will be evaluated with the Biodex Balance Device. With the camera to be placed on the sagittal, 3-meter walking distances will be recorded. Colored marks will be affixed to the right and left heels. The colored marks placed will be marked on the video and the step length and walking speed will be calculated with the Kinovea motion analysis software. In the secondary evaluations, Activity Specific Balance Confidence Scale-Short Form, Sit and Stand Test Five times, Parkinson's Activity Scale, Parkinsona Specific Quality of Life Scale (PHÖ-39) will be used.

Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Telerehabilitation Based LSVT BIG Exercise Protocol Other: Telerehabilitation Based Functional Balance and Mobility Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Telerehabilitation-based Exercise Trainings on Gait and Balance in Parkinson's Patients
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: a) TELEREHABILITATION BASED LSVT BIG TREATMENT GROUP
It is planned to recruit 16 patients with Parkinson's Disease in this group. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.
Other: Telerehabilitation Based LSVT BIG Exercise Protocol
Lee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.

Active Comparator: b) TELEREHABILITATION BASED FUNCTIONAL BALANCE AND MOBILITY EXERCISES GROUP
It is planned to recruit 16 patients with Parkinson's Disease in this group. These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.
Other: Telerehabilitation Based Functional Balance and Mobility Exercise

These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.

Exercises will get harder with each passing week and its progression will be adjusted to the patient.





Primary Outcome Measures :
  1. Mini-Best Test [ Time Frame: 15 minutes ]
    The Mini-BEST balance scale will be used in the assessment of dynamic balance, this scale is a one-dimensional and highly reliable measurement method with 14 items, requiring approximately 15 minutes to complete. The Mini-BEST test focuses on postural responses, dynamic gait and sensory orientation to reveal balance problems and is frequently used in Parkinson's patients. Each item is scored between 0 and 2. A score of 0 indicates that the person cannot fulfill that task, 28 points is the best indicator.

  2. Biodex Balance Assessment [ Time Frame: 10 minutes ]
    The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the center of foot pressure (CoP). Biodex Balance System 20 Hz. It consists of a circular platform that allows 20 degrees of platform tilt in a range of 360 degrees of motion at sampling rate. Measures of postural stability score for BBS; It is in the form of the General Stability Index (OSI), Medial-Lateral Stability Index (MLSI) and Anterior-Posterior Stability Index (APSI). The degree of unbalance of the surface can be adjusted from the most stable (level 8) to the least stable levels (level 1)

  3. Kinovea Gait Analysis [ Time Frame: 15 minutes ]
    3 meters walking distance will be recorded with the camera to be placed in the sagittal. Colored markings will be affixed to the right and left heels. The colored marks placed will be marked on the video and step lengths, walking speed and arm swing will be calculated with the Kinovea motion analysis software. The video will express the cadence (number of steps per minute), right and left stride lengths

  4. Timed Up and Go (TUG) Test [ Time Frame: 10 minutes ]
    Timed Up and Go (TUG) test is a simple, widely used and rapid test to evaluate mobility, balance and fall risk. To perform the test, participants must stand up from a standard chair, walk comfortably 3 meters from the ground, turn and return to the chair, and sit on the same chair. All steps of the test will be measured using a stopwatch


Secondary Outcome Measures :
  1. Activity Specific Balance Confidence Scale - Short Form: [ Time Frame: 5 minutes ]
    The short form of Activity Specific Balance Confidence Scale will be used to measure patients' balance confidence. Activity-Specific Balance Confidence Scale is answered with the self-perception of the individual, which consists of 16 items. It includes values in the range of 0-100 and measures the perceived ability to maintain balance under different conditions. The highest score indicates full confidence in their balance abilities. The short form of this scale consists of 6 questions of the original version of the scale and it has been stated that it is valid and reliable when associated with the risk of falling in the PD population.

  2. Five Times Sit & Stand Test [ Time Frame: 5 minutes ]
    This test will be used in our study to determine repetitive motion performance. Individuals will be instructed to cross their arms over their chest and sit down to rest their back against the back of the chair. He will be asked to sit and stand five times as soon as possible, and then time will be recorded. The performance of this test in individuals with PD has been found to be associated with balance and bradykinesia and has been recommended as a reliable method

  3. Parkinson Activity Scale [ Time Frame: 15 minutes ]
    It is a scale developed to evaluate the functional status in PD. It consists of a total of 10 items, including the sections of standing up from the chair, walking akinesia and in-bed mobilization, and provides information about the transfer status of the patients. Evaluations are made between 0 and 4, and a high score is an indicator of good performance

  4. Parkinson-Specific Quality of Life Scale [ Time Frame: 15 minutes ]
    The Parkinson-Specific Quality of Life Scale will be used in quality of life assessment. PDQ-39 is a self-report questionnaire that uses the 5-point Likert scale to assess the quality of life such as the severity of symptoms of mobility, daily living activities, emotional well-being, social support, cognition, and communication. The total score is between 0-100, and the higher the score indicates that the quality of life is at a lower level



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a definite diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and being 1-3 on the Hoehn-Yahr scale
  • A score of at least 21 on the Montreal cognitive assessment scale test
  • To be able to walk independently on flat ground without assistive devices
  • Stability of drug treatment taken in the last 1 month
  • Patients are in the "on" period

Exclusion Criteria

  • Serious hearing or vision problems
  • Having other neurological, cardiovascular, or orthopedic impairments that can prevent walking
  • Any other neurological disorder (eg dementia, cerebrovascular disease)
  • Have an education level of less than 5 years
  • Having vascular lower extremity pathologies
  • Not having internet access with a smartphone or computer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694872


Contacts
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Contact: Guzin Kaya Aytutuldu, MSc. +905366265884 guzinkaya14@gmail.com

Sponsors and Collaborators
Yeditepe University
Istanbul University-Cerrahpasa
Investigators
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Study Director: Burcu Ersoz Huseyinsinoglu, Assoc.Prof Istanbul University-Cerrahpasa
Study Chair: Nazan Karagoz Sakallı, MD Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
Study Chair: Aysu Sen, Assoc.Prof. Bakırköy Prof.Dr. Mazhar Osman Psychiatric and Neurological Diseases Hospital
Publications of Results:
Other Publications:

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Responsible Party: Guzin Kaya Aytutuldu, Principla Investigator, Yeditepe University
ClinicalTrials.gov Identifier: NCT04694872    
Other Study ID Numbers: Istanbul University Cerrahpasa
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guzin Kaya Aytutuldu, Yeditepe University:
Parkinson's Disease
Tele-rehabilitation
Exercise
LSVT BIG
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases