UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024714 |
|---|---|
| Receipt number | 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 18:55:42 |
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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
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
Atsuko.miyazaki.vj@riken.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028399
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