UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051914 |
|---|---|
| Receipt number | R000058710 |
| Scientific Title | Effect of Shopping Rehabilitation for Patients with Dementia with gait Instability - A Pilot Randomized Controlled Trial - |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2025/01/14 20:22:15 |
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Basic information
Public title
Shopping Rehabilitation for Dementia Patients.
Acronym
Investigation into whether shopping rehabilitation for dementia patients affects physical and cognitive function.
Scientific Title
Effect of Shopping Rehabilitation for Patients with Dementia with gait Instability - A Pilot Randomized Controlled Trial -
Scientific Title:Acronym
Effect of Shopping Rehabilitation for Patients with Dementia with gait Instability - A Pilot Randomized Controlled Trial -
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining whether shopping rehabilitation for dementia patients improves physical and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical function will be measured by the Short Physical Performance Battery (SPPB), gait speed.Cognitive function will be measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and the Frontal Assessment Battery (FAB), MMSE.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The first group is the shopping group, in which shopping is done. The shopping is accompanied by a physical therapist or occupational therapist who performs the shopping with walking, and physical activity and cognitive stimulation are performed once a week for 12 weeks.
Interventions/Control_2
The second group is the usual care group, which consists of simple exercise and cognitive stimulation. The usual care group also meets once a week for 12 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older, Clinical Dementia Rating (CDR) 1 or higher, SPPB less than 6, able to walk at least 4 m on their own, no exercise habits
Key exclusion criteria
Those who go shopping on a daily basis, those with neurodegenerative diseases (Parkinson's disease, Parkinson's syndrome, spinocerebellar degeneration, amyotrophic lateral sclerosis, multiple system atrophy, progressive supranuclear palsy), those with significantly impaired vision or hearing, those with severe dysphagia, hemispatial neglect, aphasia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Nakaguchi |
Organization
Hoshino Clinic
Division name
Department of Rehabilitation
Zip code
640-8342
Address
5-32 Tomodacho, Wakayama City, Wakayama Prefecture
TEL
073-422-0007
nakaguchi.pt@gmail.com
Public contact
Name of contact person
| 1st name | Takukma |
| Middle name | |
| Last name | Nakaguchi |
Organization
Hoshino Clinic
Division name
Department of Rehabilitation
Zip code
640-8342
Address
5-32 Tomodacho, Wakayama City, Wakayama Prefecture
TEL
073-422-0007
Homepage URL
nakaguchi.pt@gmail.com
Sponsor or person
Institute
Hoshino Clinic
Institute
Department
Personal name
Takuma Nakaguchi
Funding Source
Organization
Hoshino Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka college of medical secretary welfare
Address
1-2-14 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
0120-1298-59
yasumaru0223@yahoo.co.jp
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
星野クリニック（和歌山）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058710
