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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yu-Cheng Pei, MD, PhD
  • Phone Number: 3846 886-3-3281200
  • Email: yspeii@gmail.com

Study Contact Backup

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:
          • Yu-Cheng Pei, MD, PhD
          • Phone Number: 3846 886-3-3281200
          • Email: yspeii@gmail.com
        • Principal Investigator:
          • Yu-Cheng Pei, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Musical Dual Task Training
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.
Behavioral: Walking and Talking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Baseline and at 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline on Walking Speed during Dual tasking at 2 Months
Time Frame: Baseline and at 2 months
Baseline and at 2 months
Change from Baseline on the Timed Up-and-Go test at 2 Months
Time Frame: Baseline and 2 months
Baseline and 2 months
Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months
Time Frame: Baseline and at 2 months
Baseline and at 2 months
Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months
Time Frame: Baseline and at 2 months
Baseline and at 2 months
Change from Baseline on Stride Lengths during Dual Tasking at 2 Months
Time Frame: Baseline and at 2 months
Baseline and at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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