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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024714
Receipt No. R000028399
Scientific Title Effects of Group Drumming Communication Program for Improving and Preventing Dementia in Special Elderly Nursing Home
Date of disclosure of the study information 2016/11/04
Last modified on 2018/07/02

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Basic information
Public title Effects of Group Drumming Communication Program for Improving and Preventing Dementia in Special Elderly Nursing Home
Acronym Effect of drumming for preventing dementia
Scientific Title Effects of Group Drumming Communication Program for Improving and Preventing Dementia in Special Elderly Nursing Home
Scientific Title:Acronym Effect of drumming for preventing dementia
Region
Japan

Condition
Condition Dementia, Mild Cognitive Impairment, Normal elderly, Lewy body dementia, Cerebrovascular disease, Cerebral infarction, Cerebral contusion, Cerebral hemorrhage, Aftereffect of cerebral hemorrhage, Basilar artery occlusion, Cerebral arteriosclerosis, Multiple cerebral infarction, Cerebral atrophy, Vascular dementia, Chronic subdural hematoma, Parkinson's disease, Parkinsonian syndrome, Bone and joint disease, Osteoporosls, Chronic articular rheumatism, Hemiparesis, Diabetes, Disuse syndrome, Locomotive Syndrome
Classification by specialty
Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the beneficial effects on cognitive function for dementia by Group Drumming Communication Program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cognitive function and the range of motion are compared before and after intervention for three months.
Key secondary outcomes Evaluation of the effect of exercise is to measure the momentum of the drum session by the gyro and acceleration sensors.
Communication effect of the drum session, the brain activity of the prefrontal cortex measured in fNIRS (small near-infrared light spectral measuring device) in the drum playing simultaneously, to confirm the change of interpersonal nerve synchronization.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Perform the drum communication program of 30 minutes three times a week three months.
Interventions/Control_2 No treatment for three months.
After three months, there is the program as a service session.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Admitted to a special nursing home.
Keeping sitting position on wheel chair.
After enough explanation of the trial, those who agree with participation and give written informed consent.
Key exclusion criteria Patients who are judged by the collaborative research investigator (psychiatrist)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuko Miyazaki
Organization RIKEN
Division name Research Cluster for Innovation, Nakamura Laboratory
Zip code
Address 2-1 Hirosawa, Wako, Saitama 351-0198 Japan
TEL +81(0)48-467-9477
Email Atsuko.miyazaki.vj@riken.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko Miyazaki
Organization RIKEN
Division name Research Cluster for Innovation, Nakamura Laboratory
Zip code
Address 2-1 Hirosawa, Wako, Saitama 351-0198 Japan
TEL +81(0)48-467-9477
Homepage URL
Email Atsuko.miyazaki.vj@riken.jp

Sponsor
Institute RIKEN
Institute
Department

Funding Source
Organization JSPS
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 社会福祉法人 天佑 特別養護老人ホーム アンミッコ(埼玉県)/ Social welfare corporation Tenyu, Special nursing home Ammicco

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
 The Drumming Communication Program could be carried out for three months at a special nursing home for the elderly requiring high nursing care level. Participants with dementia have difficulty in imitating commands and gestures necessary for exercise therapy and programs. However, they were able to exercise with drums by using their rhythm response function. The intervention group showed improvement in their cognitive functions in both the MMSE and FAB scores. As for motor functions, the intervention group showed improvement in their shoulder and wrist flexion. The causal relationship between the declines in the cognitive and physical functions is bi-directional. Exercise intervention by drums not only affected motor functions but also cognitive functions as well.
 We propose a new rehabilitation program based on group drumming to improve cognitive and motor functions, for patients with dementia and other debilitating diseases who have rhythm response capability.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 06 Day
Last follow-up date
2017 Year 05 Month 11 Day
Date of closure to data entry
2017 Year 05 Month 11 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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