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The Effects of Tele-rehabilitation Interventions in Parkinson's Patients

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home-based telerehabilitation with exercise videos
Exercise brochure
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Telerehabilitation, Physical Therapy Modalities, Nervous System Diseases, Home-based, Physiotherapy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • İstanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Telerehabilitation-video group

Telerehabilitation-brochure group

Arm Description

This group will perform their exercises with prepared personalized exercise videos through the telerehabilitation system 3 days a week for 8 weeks.

This group will perform exercises with personalized exercise brochures defined through the telerehabilitation system 3 days a week for 8 weeks.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 24, 2021
Last Updated
April 11, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05187195
Brief Title
The Effects of Tele-rehabilitation Interventions in Parkinson's Patients
Official Title
The Effects of Two Different Tele-rehabilitation Interventions on Physical Parameters and Activities of Daily Living in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2021 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Telerehabilitation, Physical Therapy Modalities, Nervous System Diseases, Home-based, Physiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation-video group
Arm Type
Experimental
Arm Description
This group will perform their exercises with prepared personalized exercise videos through the telerehabilitation system 3 days a week for 8 weeks.
Arm Title
Telerehabilitation-brochure group
Arm Type
Experimental
Arm Description
This group will perform exercises with personalized exercise brochures defined through the telerehabilitation system 3 days a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Home-based telerehabilitation with exercise videos
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise brochure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Single Leg Stance Test - SLS (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Five Times Sit to Stance Test - 5XSST (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Romberg Test - RT (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Independent Standing Test (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Katz Index of Independence in Activities on Daily Living (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Secondary Outcome Measure Information:
Title
Modified Falls Efficacy Scale (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
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)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Fatigue Severity Scale (The change between the initial value and value after 2 months will be evaluated)
Description
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.
Time Frame
Baseline and end of weeks 8
Title
Global Rating of Change Scales
Description
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.
Time Frame
End of weeks 8
Title
System Usability Scale
Description
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.
Time Frame
End of weeks 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yılmaz, M.Sc
Organizational Affiliation
Istanbul University- Cerrahpasa Institute of Postgraduate Education
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yonca Zenginler Yazgan, PhD
Organizational Affiliation
Istanbul University- Cerrahpasa Faculty of Health Science
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul University-Cerrahpasa
City
Istanbul
State/Province
Buyukcekmece
ZIP/Postal Code
34500
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Effects of Tele-rehabilitation Interventions in Parkinson's Patients

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