Musical Dual Task Training to Improve Attention Control for Dementia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01709188
First received: October 1, 2012
Last updated: November 6, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Dementia
Behavioral: Musical Dual Task Training
Behavioral: Walking and Talking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Musical Dual Task Training on Attention Control and Associated Gait Stability of Patients With Mild to Moderate Dementia

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Change from Baseline on the Trail Making Test at 2 months [ Time Frame: Baseline and at 2 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline on Walking Speed during Dual tasking at 2 Months [ Time Frame: Baseline and at 2 months ] [ Designated as safety issue: No ]
  • Change from Baseline on the Timed Up-and-Go test at 2 Months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months [ Time Frame: Baseline and at 2 months ] [ Designated as safety issue: No ]
  • Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months [ Time Frame: Baseline and at 2 months ] [ Designated as safety issue: No ]
  • Change from Baseline on Stride Lengths during Dual Tasking at 2 Months [ Time Frame: Baseline and at 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709188

Contacts
Contact: Yu-Cheng Pei, MD, PhD 886-3-3281200 ext 3846 yspeii@gmail.com
Contact: Yu-Ling Chen, MA, MME 886-922123809 yuling1015@gmail.com

Locations
Taiwan
Chang Gung Medical Foundation Recruiting
Taoyuan, Taiwan, 333
Contact: Yu-Cheng Pei, MD, PhD    886-3-3281200 ext 3846    yspeii@gmail.com   
Principal Investigator: Yu-Cheng Pei, MD, PhD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yu-Cheng Pei, MD, PhD Chang Gung Medical Foundation
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01709188     History of Changes
Other Study ID Numbers: 101-2201B, 20216
Study First Received: October 1, 2012
Last Updated: November 6, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Musical Dual Task Training
dementia
attention control
dual task cost
gait stability

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014