UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049046 |
|---|---|
| Receipt number | R000055875 |
| Scientific Title | Explore study of the efficacy and safety of hand function strengthening gloves |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/09/28 10:56:39 |
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Basic information
Public title
Evaluation the efficacy and safety of hand function strengthening gloves in patients with Parkinson's disease
Acronym
the efficacy of hand function strengthening gloves in patients with Parkinson's disease
Scientific Title
Explore study of the efficacy and safety of hand function strengthening gloves
Scientific Title:Acronym
Explore study of the efficacy and safety of hand function strengthening gloves
Region
| Japan |
Condition
Condition
Parkinson Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating changes in finger function with hand function strengthening gloves
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip Strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
with hand function strengthening gloves
Interventions/Control_2
without hand function strengthening gloves
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients aged between 20 and 90
2. Patients with clinically probable PD or higher as the diagnostic criteria for Parkinson's disease
Parkinson's disease diagnostic criteria according to 2015 MDS-PD criteria
3. Patients who have given informed consent in writing
Key exclusion criteria
1.Patients who have undergone surgery or administration of drugs not approved in Japan for Parkinson disease within 12 months before obtaining informed consent
2.Patients who have previously received drugs that have been published as having disease-modifying effects on Parkinson's disease
3.Patients with extreme ON-OFF motor symptoms
4.Patients with advanced dement
5.Patients with severe aphasia or higher brain dysfunction
6.Patients with significant mental illness
7.Patients who cannot answer the questionnaire
8.Patients with a history of epileptic seizures
9.Patients using a deep brain stimulator
10.Pregnant patients
11.Patients who are judged to be inappropriate for this study by the principal investigator or coinvestigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoo |
| Middle name | |
| Last name | Mano |
Organization
Nara Prefectural General Medical Center
Division name
Rehabilitation
Zip code
630-8581
Address
2 Chome-897-5 Shichijo Nishimachi, Nara
TEL
0742-46-6001
manoneuro@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoo |
| Middle name | |
| Last name | Mano |
Organization
Nara Prefectural General Medical Center
Division name
Rehabilitation
Zip code
630-8581
Address
2 Chome-897-5 Shichijo Nishimachi, Nara
TEL
0742-46-6001
Homepage URL
manoneuro@naramed-u.ac.jp
Sponsor or person
Institute
Nara Prefectural General Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Prefectural General Medical Center
Address
2 Chome-897-5 Shichijo Nishimachi, Nara
Tel
0742-46-6001
manoneuro@naramed-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
