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Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motor-Motor Dual Task Physical Exercises
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 87 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being diagnosed with idiopathic Parkinson's Disease Getting at least 21 points from the Montreal Cognitive Assessment Scale test Stability of drug therapy taken in the last 1 month Being in the "ten" period of the patients Being able to walk independently on flat ground (3 and above according to Functional Ambulation Classification) Exclusion Criteria: • Serious hearing or vision problems Having other neurological, cardiovascular or orthopedic disorders that may prevent walking Any other neurological disorder (eg dementia, cerebrovascular disease) Having an education level of less than 5 years Patients with a pacemaker Having vascular lower extremity pathologies Not having internet access with a smart phone or computer

Sites / Locations

  • Yeditepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Motor-Motor Dual Task Physical Exercises

Cognitive-Motor Dual Task Physical Exercises

Physical exercise

Arm Description

Motor-Motor Dual Task Physical Exercises will be given to the participants

Cognitive-Motor Dual Task Physical Exercises will be given to the participants

Physical exercise will be given to the participants

Outcomes

Primary Outcome Measures

Parkinson's Disease Quality of Life Questionnaire
Parkinson's Disease Quality of Life Questionnaire
Montreal Cognitive Assessment Scale (MoCA)
Montreal Cognitive Assessment Scale (MoCA)
Berg Balance Scale (BBS)
Berg Balance Scale (BBS)
10 meter walking speed test
10 meter walking speed test
Timed Up And Go Test
Timed Up And Go Test
Fall Efficiency Scale - International
Fall Efficiency Scale - International
Five Times Sit to Stand Test
Five Times Sit to Stand Test

Secondary Outcome Measures

Full Information

First Posted
May 30, 2023
Last Updated
June 30, 2023
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05894473
Brief Title
Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease
Official Title
Comparison of the Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease - A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
August 2, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

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
The ability to respond to multiple stimuli is impaired in Parkinson's patients. Traditional rehabilitation approaches focus only on balance and gait training, but individuals with Parkinson's disease need to perform multiple tasks in daily life.
Detailed Description
The dual-task (DT) methodology aims to perform two tasks simultaneously. There is no study in which motor and cognitive dual-task exercises are given together and followed up remotely in elderly individuals with PD. Therefore, it was aimed to compare the effects of telerehabilitation method and motor and cognitive dual-task exercises on cognitive function, balance, walking, fall risk and quality of life in individuals with Parkinson's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Motor-Motor Dual Task Physical Exercises
Arm Type
Active Comparator
Arm Description
Motor-Motor Dual Task Physical Exercises will be given to the participants
Arm Title
Cognitive-Motor Dual Task Physical Exercises
Arm Type
Active Comparator
Arm Description
Cognitive-Motor Dual Task Physical Exercises will be given to the participants
Arm Title
Physical exercise
Arm Type
Active Comparator
Arm Description
Physical exercise will be given to the participants
Intervention Type
Other
Intervention Name(s)
Motor-Motor Dual Task Physical Exercises
Intervention Description
Only physical exercise and motor dual tasks will be given
Primary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life Questionnaire
Description
Parkinson's Disease Quality of Life Questionnaire
Time Frame
8 weeks
Title
Montreal Cognitive Assessment Scale (MoCA)
Description
Montreal Cognitive Assessment Scale (MoCA)
Time Frame
8 weeks
Title
Berg Balance Scale (BBS)
Description
Berg Balance Scale (BBS)
Time Frame
8 weeks
Title
10 meter walking speed test
Description
10 meter walking speed test
Time Frame
8 weeks
Title
Timed Up And Go Test
Description
Timed Up And Go Test
Time Frame
8 weeks
Title
Fall Efficiency Scale - International
Description
Fall Efficiency Scale - International
Time Frame
8 weeks
Title
Five Times Sit to Stand Test
Description
Five Times Sit to Stand Test
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being diagnosed with idiopathic Parkinson's Disease Getting at least 21 points from the Montreal Cognitive Assessment Scale test Stability of drug therapy taken in the last 1 month Being in the "ten" period of the patients Being able to walk independently on flat ground (3 and above according to Functional Ambulation Classification) Exclusion Criteria: • Serious hearing or vision problems Having other neurological, cardiovascular or orthopedic disorders that may prevent walking Any other neurological disorder (eg dementia, cerebrovascular disease) Having an education level of less than 5 years Patients with a pacemaker Having vascular lower extremity pathologies Not having internet access with a smart phone or computer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Şükriye Çakır
Phone
0216 578 00 00
Email
sukriye.cakir@yeditepe.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeditepe University
Organizational Affiliation
Yeditepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease

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