UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Group Drumming Communication Program for Improving and Preventing Dementia in Special Elderly Nursing Home
Title of the study (Brief title)	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	Atsuko Miyazaki
Organization	RIKEN
Division name	Research Cluster for Innovation, Nakamura Laboratory
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	Atsuko Miyazaki
Organization	RIKEN
Division name	Research Cluster for Innovation, Nakamura Laboratory
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000028399