NCT01709188

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 8, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 1, 2012

Last Update Submit

November 6, 2012

Conditions

Keywords

Musical Dual Task Trainingdementiaattention controldual task costgait stability

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline on the Trail Making Test 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 Outcomes (5)

  • Change from Baseline on Walking Speed during Dual tasking at 2 Months

    Baseline and at 2 months

  • Change from Baseline on the Timed Up-and-Go test at 2 Months

    Baseline and 2 months

  • Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months

    Baseline and at 2 months

  • Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months

    Baseline and at 2 months

  • Change from Baseline on Stride Lengths during Dual Tasking at 2 Months

    Baseline and at 2 months

Study Arms (2)

Musical Dual Task Training

EXPERIMENTAL

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

Walking and Talking

ACTIVE COMPARATOR

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

Interventions

Musical Dual Task Training
Walking and Talking

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other known neurologic disorders such as stroke or Parkinson's disease
  • significant orthopedic, visual, and hearing impairment that hinders ambulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Medical Foundation

Taoyuan District, Taiwan, 333, Taiwan

RECRUITING

Related Publications (1)

  • van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

MeSH Terms

Conditions

Dementia

Interventions

Walking

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Yu-Cheng Pei, MD, PhD

    Chang Gung Medical Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Cheng Pei, MD, PhD

CONTACT

Yu-Ling Chen, MA, MME

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 18, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 8, 2012

Record last verified: 2012-10

Locations