- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07641569
Comparison of Two Different Dual-Task Training Methods in Patients With Parkinson's Disease
Comparison of Motor-Motor and Cognitive-Motor Dual-Task Training in Patients With Parkinson's Disease
The aim of this study is to compare the effectiveness of motor-motor dual-task training and cognitive-motor dual-task training in patients with Parkinson's disease.The main questions it aims to answer are:
- Whether there is a difference between motor-motor dual-task training and cognitive-motor dual-task training in patients with Parkinson's disease in terms of their effects on motor symptoms, balance, gait, functional mobility, activities of daily living, dual-task activities, cognitive functions, and balance confidence.
Researchers will compare single-task training, motor-motor dual task training and cogvitive-motor dual task training.
Participants will:
- Receive exercise training at the study clinic twice a week for approximately 45 minutes each time, for 6 weeks.
- Participate in assessments at the study clinic before and after exercise training.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with Parkinson's disease by a neurologist according to the UK Brain Bank criteria.
- Being in stages 1-3 according to the Hoehn-Yahr Scale.
Exclusion Criteria:
- Presence of a neurological disease other than Parkinson's disease
- Cognitive impairment (Standardized Mini Mental Test score less than 24)
- Having undergone deep brain stimulation surgery
- Having a visual, auditory, or perceptual problem
- Having any orthopedic, rheumatological, or other condition that may affect walking and balance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Single Task Training
Single task balance and walking training
|
Single task balance and walking exercises.
5-minute warm-up period, followed by 15 minutes of balance exercises and 15 minutes of walking exercises with a 5-minute rest in between, and then a 5-minute cool-down period.
|
|
Experimental: Motor-Motor Dual Task Training
Motor-motor dual task balance and walking training
|
Motor-motor dual task balance and walking exercises.
Motor-motor dual task balance and walking exercises.
5-minute warm-up period, followed by 15 minutes of balance exercises and 15 minutes of walking exercises concurrently performed with upper extremity motor tasks with a 5-minute rest in between, and then a 5-minute cool-down period.
|
|
Experimental: Cognitive-Motor Dual Task Training
Cognitive-motor dual task balance and walking training
|
Cognitive-motor dual task balance and walking exercises.
Cognitive-motor dual task balance and walking exercises.
5-minute warm-up period, followed by 15 minutes of balance exercises and 15 minutes of walking exercises concurrently performed with cognitive tasks with a 5-minute rest in between, and then a 5-minute cool-down period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) - PART 3
Time Frame: From enrollment to the end of training at 6 weeks
|
UPDRS is a reliable and valid scale that assesses cognitive skills, mood, daily living activities, motor skills, motor fluctuations, dyskinesias and autonomic dysfunction and is widely used in clinical studies and research in Parkinson's disease.
The motor symptoms section, which is the third section of this scale, will be used.
|
From enrollment to the end of training at 6 weeks
|
|
Hoehn & Yahr Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
It is a staging system that provides information quickly in determining the severity and symptoms of Parkinson's disease.
|
From enrollment to the end of treatment at 6 weeks
|
|
Single-Leg Stance Test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This is a test method used to assess static balance.
The patient's preferred foot is raised without touching the supporting leg, and initially, the eyes are open.
The eyes are fixed towards the head, and the patient is expected to maintain their balance for 60 seconds.
The time the participant maintains their balance is recorded.
|
From enrollment to the end of treatment at 6 weeks
|
|
Functional Reach Test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This test is designed to assess dynamic balance.
In the test, the participant is positioned sideways next to a wall, with their torso upright, the shoulder on the wall flexed to 90°, and the elbow fully extended.
The participant is then asked to make a fist with the same arm, and the position of the third metacarpal head is marked on the wall.
The participant reaches forward with their knees fully extended; the position of the third metacarpal head is marked again, and the participant returns to the starting position.
The difference between the two marks is measured with a tape measure.
|
From enrollment to the end of treatment at 6 weeks
|
|
10 Meter Walking Test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Participants are asked to walk at normal walking speed for a distance of 10 meters and the time is recorded.
|
From enrollment to the end of treatment at 6 weeks
|
|
Motor-Motor Dual Task Cost of Walking
Time Frame: From enrollment to the end of treatment at 6 weeks
|
To assess the motor-motor dual-task cost of walking, patients will perform the 10-meter walk test once as a single task and once while holding an empty plate on a tray in their hands. The dual-task cost will be calculated as a percentage using the following formula: [(Dual-task performance - Single-task performance)/ (Single-task performance) x 100] |
From enrollment to the end of treatment at 6 weeks
|
|
Cognitive-Motor Dual Task Cost of Walking
Time Frame: From enrollment to the end of treatment at 6 weeks
|
To assess cognitive-motor dual-task cost of walking, patients will perform the 10-Meter Walk Test once as a single task and once as a dual-task test, counting backwards in increments of 7 from a three-digit number greater than 300. Dual-task cost will be calculated as a percentage using the following formula: [(Dual-task performance - Single-task performance)/ (Single-task performance) x 100] |
From enrollment to the end of treatment at 6 weeks
|
|
Timed Up and Go Test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This test is used to assess functional mobility levels.
The test involves using a standard chair with the individual's knees flexed at 90° and their backrest against it.
The individual is asked to stand up from the chair, walk 3 meters, turn around, and then walk back to the chair and sit down.
The test begins with the command "walk," and the test duration is measured with a stopwatch and recorded in seconds.
|
From enrollment to the end of treatment at 6 weeks
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) - PART 2
Time Frame: From enrollment to the end of treatment at 6 weeks
|
It consists of thirteen items.
The assessment is based on anamnesis information regarding how the patient functions in various activities.
The presence of sensory complaints that may be related to tremor and parkinsonism is also included in this section as they can affect daily living activities.
Each item is evaluated using a scoring system between '0' and '4'.
|
From enrollment to the end of treatment at 6 weeks
|
|
Dual Task Questionnaire
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This test is used to assess the challenges encountered in daily tasks involving dual work.
It consists of 10 questions and is administered via face-to-face interview.
Each question is scored between 0 and 4. A score of "4" indicates frequent challenges, while a score of "0" indicates no challenges.
|
From enrollment to the end of treatment at 6 weeks
|
|
Trail Making Test
Time Frame: From enrollment to the end of treatment at 6 weeks
|
It is used to assess executive functions and attention.
The test consists of two parts, A and B. In part A, the individual is asked to combine numbers from 1 to 25, and the completion time is recorded.
In part B, the individual completes a sequence where each number corresponds to a letter, and the completion time is recorded.
|
From enrollment to the end of treatment at 6 weeks
|
|
Activity-Specific Balance Confidence Scale
Time Frame: From enrollment to the end of treatment at 6 weeks
|
This is a commonly used scale for assessing balance confidence.
The scale evaluates whether individuals believe they can perform daily living activities without losing their balance or becoming unsteady.
It consists of sixteen items.
Each item is scored between a minimum of "0" (unconfident) and a maximum of "100" (completely confident).
The base score is calculated by dividing the total score by 16.
Higher values indicate that the person feels good about their balance, while lower values are associated with an increased risk of falls.
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 2026-152
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.
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