DementiaNCT01709188
Musical Dual Task Training to Improve Attention Control for Dementia
A study testing Musical Dual Task Training and Walking and Talking in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Musical Dual Task Training and Walking and Talking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other known neurologic disorders such as stroke or Parkinson's disease
- significant orthopedic, visual, and hearing impairment that hinders ambulation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Medical Foundation
Taoyuan, Taiwan, 333
Yu-Cheng Pei, MD, PhD, 886-3-3281200 ext. 3846, yspeii@gmail.com
Yu-Cheng Pei, MD, PhD
About this study
Official title: 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.
- Conditions
- Dementia
- Being tested
- Musical Dual Task Training, Walking and Talking
- Keywords
- Musical Dual Task Training, dementia, attention control, dual task cost, gait stability
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical Dual Task TrainingBehavioural
Walking and TalkingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Walking and Talking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 2 months
Secondary outcomes (5)
Change from Baseline on Walking Speed during Dual tasking at 2 Months
Measured: Baseline and at 2 months
Change from Baseline on the Timed Up-and-Go test at 2 Months
Measured: Baseline and 2 months
Change from Baseline on the 7-item Short Falls Efficacy Scale International at 2 Months
Measured: Baseline and at 2 months
Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months
Measured: Baseline and at 2 months
Change from Baseline on Stride Lengths during Dual Tasking at 2 Months
Measured: Baseline and at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Cheng Pei, MD, PhD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709188
- Sponsor's protocol ID
- 101-2201B
- Other IDs
- 20216
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40049590
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Musical Dual Task Training on Attention Control and Associated Gait Stability of Patients With Mild to Moderate Dementia
- ClinicalTrials.gov ID
- NCT01709188
- Acronym / sponsor ID
- 101-2201B
- Conditions
- Dementia
- Keywords
- Musical Dual Task Training, dementia, attention control, dual task cost, gait stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Musical Dual Task Training | Experimental | Behavioral: Musical Dual Task Training60 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. |
| Walking and Talking | Active comparator | Behavioral: Walking and Talking60 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- other known neurologic disorders such as stroke or Parkinson's disease
- significant orthopedic, visual, and hearing impairment that hinders ambulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical Dual Task Training | Behavioural | Musical Dual Task Training |
| Walking and Talking | Behavioural | Walking and Talking |
Primary outcome
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.
5 secondary outcomes
Change from Baseline on Walking Speed during Dual tasking at 2 Months
Time frame: Baseline and at 2 months
Change from Baseline on the Timed Up-and-Go test at 2 Months
Time frame: 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
Change from Baseline on the Cohen-Mansfield Agitation Inventory scale at 2 months
Time frame: Baseline and at 2 months
Change from Baseline on Stride Lengths during Dual Tasking at 2 Months
Time frame: Baseline and at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Derived from this study: PubMed 40049590van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Cheng Pei, MD, PhD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Musical Dual Task Training and Walking and Talking in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Cheng Pei, MD, PhD (886-3-3281200 ext. 3846, yspeii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the Trail Making Test at 2 months (time frame: Baseline and at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.