UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048872 |
|---|---|
| Receipt number | R000055695 |
| Scientific Title | Effects of Insole with Toe-Grip Bar on Balance and Walking Function in Patients with Parkinson Disease |
| Date of disclosure of the study information | 2022/09/07 |
| Last modified on | 2022/09/07 12:52:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Insole with Toe-Grip Bar on Balance and Walking Function in Patients with Parkinson Disease
Acronym
Effects of Insole with Toe-Grip Bar on Balance and Walking Function in Patients with Parkinson Disease
Scientific Title
Effects of Insole with Toe-Grip Bar on Balance and Walking Function in Patients with Parkinson Disease
Scientific Title:Acronym
Effects of Insole with Toe-Grip Bar on Balance and Walking Function in Patients with Parkinson Disease
Region
| Japan |
Condition
Condition
Patients with Parkinson Disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of insoles with a toe-grip bar on balance and walking function in patients with PD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Center of gravity sway, walking parameters
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Insoles with toe-grip bar
Interventions/Control_2
General insoles
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with PD
Key exclusion criteria
Patients with orthopedic, cardiovascular, or psychiatric diseases and patients who could not perform all measurements were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Murata |
Organization
Kyoto Tachibana University
Division name
Faculty of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city
TEL
0755711111
nakano-h@tachibana-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Nakano |
Organization
Kyoto Tachibana University
Division name
Facultuy of Health Sciences
Zip code
607-8175
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city
TEL
0755711111
Homepage URL
nakano-h@tachibana-u.ac.jp
Sponsor or person
Institute
Kyoto Tachibana University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Tachibana University
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
Kyoto Tachibana University
Address
34 Yamada-cho, Oyake, Yamashina-ku, Kyoto-city
Tel
0755711111
nakano-h@tachibana-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
| 2022 | Year | 09 | Month | 07 | 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
29
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
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 03 | 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 | 07 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055695
