- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709188
Musical Dual Task Training to Improve Attention Control for Dementia
November 6, 2012 updated by: Chang Gung Memorial Hospital
The Effects of Musical Dual Task Training on Attention Control and Associated Gait Stability of Patients With Mild to Moderate Dementia
The purpose of this project is to determine if the Musical Dual Task Training program improves attention control that influences measures of gait performances under dual tasking, balance, fear of falling, and behavioral disturbance in patients with mild to moderate dementia.
This Musical Dual Task Training protocol is structured with musical content and patients are required to do musical tasks including singing and playing instruments contingent on visual or auditory cues while walking.
This paradigm is designed to include music making because it involves great demands on attention and memory that might elicit experience-dependent plasticity in the brain.
Musical Dual Task Training is proposed to strengthen brain networking for attention control that consequently may improve the gait performances in patients with dementia, as indicated by reducing dual task cost on gait.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Medical Foundation
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Contact:
- Yu-Cheng Pei, MD, PhD
- Phone Number: 3846 886-3-3281200
- Email: yspeii@gmail.com
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Principal Investigator:
- Yu-Cheng Pei, MD, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a mild to moderate dementia diagnosis with Clinical Dementia Rating (CDR) score: .5, 1, or 2
- ability to walk 10 meters independently without the use of a walker or cane, or the assistance by another person
Exclusion Criteria:
- other known neurologic disorders such as stroke or Parkinson's disease
- significant orthopedic, visual, and hearing impairment that hinders ambulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Musical Dual Task Training
60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist.
Within the Musical Dual Task Training session, participant will be asked to sing familiar songs, play simple percussive musical instruments such as paddle drums and shakers, sing while walking, and play instruments while walking.
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Active Comparator: Walking and Talking
60 minute individual session once a week across 2 months for a total of 8 sessions.Each session will be led by a qualified music therapist.
Within the walking and talking session, participant will be asked to read a newspaper article prior to a walk and have a conversation with the music therapist based on the content of the news while walking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline on the Trail Making Test at 2 months
Time Frame: Baseline and at 2 months
|
Trail Making Test Part A requires the participants to draw lines to connect a set of 25 circles as fast as possible following the sequential order of numbers (1,2,3…25) while still maintaining accuracy.
Trail Making Test Part B is in a same format, but participants are required to alternates between numbers and letters (1, A, 2, B, etc.).
The circles in Part B include both numbers (1 - 13) and letters (A - L). Results for both Part A and Part B are reported as the number of seconds required to complete the task.
Higher scores indicate greater impairment.
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Baseline and at 2 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline on Walking Speed during Dual tasking at 2 Months
Time Frame: Baseline and at 2 months
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Baseline and at 2 months
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Change from Baseline on the Timed Up-and-Go test at 2 Months
Time Frame: Baseline and 2 months
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Baseline and 2 months
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Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months
Time Frame: Baseline and at 2 months
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Baseline and at 2 months
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Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months
Time Frame: Baseline and at 2 months
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Baseline and at 2 months
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Change from Baseline on Stride Lengths during Dual Tasking at 2 Months
Time Frame: Baseline and at 2 months
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Baseline and at 2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yu-Cheng Pei, MD, PhD, Chang Gung Medical Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 16, 2012
First Posted (Estimate)
October 18, 2012
Study Record Updates
Last Update Posted (Estimate)
November 8, 2012
Last Update Submitted That Met QC Criteria
November 6, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101-2201B
- 20216 (University of Kansas)
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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