- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06803212
Investigation of Dual-Task Exercise's Effect in Parkinson's Disease
Effect of Dual-Task Interference on Upper Extremity Motor Experience With Parkinson's Disease
This study was conducted to investigate the effects of dual-task training on upper extremity motor functions in patients with Parkinson's disease. A total of 32 patients participated in the study. Patients were divided into two groups by randomization. One group received only conventional physiotherapy applications, while the other group performed dual-task exercises in addition. Dual-task exercises were performed while conventional treatment was applied. The treatment program was applied as 60x5x6 min/day/week.
Conventional treatment was determined according to the individual needs of the patients, including the lower and upper extremities. Dual-task interventions included performing such as counting backward, word recall, and reading words backward.
Assessments were repeated twice: Baseline and after a 30-session. "Demographic Information", "Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)", "Box and Block Test" and "Parkinson Disease Questionnaire (PDQ-39) were used as assessment tools.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- İstanbul Tıp Merkezi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 50-85 years with a diagnosis of Stage 1-3 Parkinson's disease, based on the Hoehn & Yahr Scale
- Patients had to have no issues with performing basic mathematical operations, - A Mini-Mental State Examination (MMSE) score above 24 points,
- Regular medication use for at least 4 weeks (for patients who were prescribed medical treatment),
- No comorbid neurological, neuromuscular, or orthopedic diseases
Exclusion Criteria:
- Patients with vision or hearing impairments,
- Moderate-to-severe fluctuations in tremor or dyskinesia,
- Having deep brain stimulator implants, or sensory loss in the upper extremities.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Therapy
This group were performed just conventional physiotherapy.
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The patients' conventional physiotherapy program included stretching, strengthening, balance, and coordination exercises according to their individual needs
|
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Experimental: Dual-Task Interference
Dual-task exercises were applied during conventional physiotherapy practices.
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The patients' conventional physiotherapy program included stretching, strengthening, balance, and coordination exercises according to their individual needs
This intervention consisted of counting backward, reading words backward, and remembering word exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
Time Frame: Baseline of the study
|
The scale consists of four separate domains.
The first section includes non-motor experiences in daily life (13 items), the second section includes motor experiences in daily life (13 items), the third section involves motor examination (33 items), and the last section addresses motor complications (6 items).
The scale contains 65 individual items in total.
Items are generally scored between 0-4, with some Yes/No items.
The domains of the scale directly related to the upper extremities, including eating, dressing, cleaning, writing, rigidity, finger movements, hand movements, pronation and supination of the hand, postural tremor in the hands, kinetic tremor in the hands, resting tremor, and tremor persistence, were used in this study (Figure 1).
The MDS-UPDRS scoring was performed while patients were in the "ON" state.
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Baseline of the study
|
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Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS):
Time Frame: End of the 30th physiotherapy session
|
The scale consists of four separate domains.
The first section includes non-motor experiences in daily life (13 items), the second section includes motor experiences in daily life (13 items), the third section involves motor examination (33 items), and the last section addresses motor complications (6 items).
The scale contains 65 individual items in total.
Items are generally scored between 0-4, with some Yes/No items.
The domains of the scale directly related to the upper extremities, including eating, dressing, cleaning, writing, rigidity, finger movements, hand movements, pronation and supination of the hand, postural tremor in the hands, kinetic tremor in the hands, resting tremor, and tremor persistence, were used in this study (Figure 1).
The MDS-UPDRS scoring was performed while patients were in the "ON" state.
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End of the 30th physiotherapy session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box Block Test (BBT)
Time Frame: Baseline of the study
|
The BBT consists of a panel and two boxes, one containing 150 wooden blocks.
The patient is asked to transfer blocks from one box to another within 60 seconds, one block at a time, using only one hand.
The test is repeated with both hands.
The number of blocks moved provides the total score.
A higher score indicates better manual dexterity.
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Baseline of the study
|
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Box Block Test (BBT)
Time Frame: End of the 30th physiotherapy session
|
The BBT consists of a panel and two boxes, one containing 150 wooden blocks.
The patient is asked to transfer blocks from one box to another within 60 seconds, one block at a time, using only one hand.
The test is repeated with both hands.
The number of blocks moved provides the total score.
A higher score indicates better manual dexterity.
|
End of the 30th physiotherapy session
|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time Frame: Baseline of the study
|
This licensed tool assesses the quality of life associated with Parkinson's disease with a total of 39 items.
Each item is scored between 0-4, with higher scores indicating poor quality of life.
Responses are converted into hundredths for scoring, and the total score ranges from 0 to 100 points.
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Baseline of the study
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Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time Frame: End of the 30th physiotherapy session
|
This licensed tool assesses the quality of life associated with Parkinson's disease with a total of 39 items.
Each item is scored between 0-4, with higher scores indicating poor quality of life.
Responses are converted into hundredths for scoring, and the total score ranges from 0 to 100 points.
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End of the 30th physiotherapy session
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Demographic Data Form
Time Frame: Baseline of the study
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This form was developed by the investigators and included age, body mass index, disease duration, sex, dominant limb, education level, presence of freezing, presence of tremor, MMSE score, total daily dose of levodopa, and Hoehn & Yahr Staging.
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Baseline of the study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2024/109 (Other Identifier: Ethics Committee Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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