UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048428 |
|---|---|
| Receipt number | R000055160 |
| Scientific Title | Immediate Effects of Heel up on Stand-up Motion Time in Patients with Parkinson's Disease -A Study Using a Crossover Design- |
| Date of disclosure of the study information | 2022/07/21 |
| Last modified on | 2023/07/22 20:30:55 |
* 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
Immediate Effects of Heel up on Stand-up Motion Time in Patients with Parkinson's Disease
Acronym
Immediate Effects of Heel up on Stand-up Motion Time in Patients with Parkinson's Disease
Scientific Title
Immediate Effects of Heel up on Stand-up Motion Time in Patients with Parkinson's Disease
-A Study Using a Crossover Design-
Scientific Title:Acronym
Immediate Effects of Heel up on Stand-up Motion Time in Patients with Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the stand-up motion time under the heel up condition with the tilting version and the stand-up motion time in the flat condition for patients with Parkinson's disease. The immediate effect on stand-up motion time will be examined using a crossover design. In addition, motor and cognitive functions will be assessed and examined in relation to motion time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Modified Five-repetition Sit-to-Stand Test(Measured flat and heel up conditions on the same day)
Key secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part3
Mini- Mental State Examinaton
Knee Extensor Strength with Hand-held Dynamometer
Active Range of Motion (Ankle Dorsiflexion Angle, Popliteal Angle)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A: Flat condition standing up start group (baseline)
Standing up on a flat condition, barefoot on a non-slip mat on the floor, 5 times standing up and sitting down test was measured.
Interventions/Control_2
B: Heel up condition standing start group
The 5 degrees, 10 degrees, and 15 degrees tilting plates are inserted in line with the heel, and the five times stand-sit test is measured.
To offset the sequential effects of 5 degrees, 10 degrees, and 15 degrees, three patterns were randomly assigned and measured: 1) 5 degrees, 10 degrees, 15 degrees, 2) 10 degrees, 15 degrees, 5 degrees, and 3) 15 degrees,5 degrees, 10 degrees.
The five standing tests will be conducted on the same day to account for diurnal variation due to Parkinson's disease, progression of symptoms, and changes in the dosage of prescribed medications.
A 10-minute rest period will be allowed between the stand-up time measurement in the heel up condition and the flat stand-up time measurement as a washout period to eliminate the effects of carryover from the movement practice. In addition, during the measurement in the heel up condition, a 2-minute rest period shall be provided, depending on subjective symptoms, in consideration of fatigue.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case of Parkinson's disease diagnosed by a neurologist
Key exclusion criteria
Patient is unable to stand up from a 52cm chair with upper limb support on a table with both hands on the table.
Cases with significant cognitive decline, inability to understand what is being performed, and inability to follow instructions.
Minors
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Nakayama |
Organization
Susaki Kuroshio Hospital
Kochi University Graduate School of Medicine
Division name
Department of Rehabilitation
Zip code
785-8501
Address
4-30 Midorimachi, Susaki-shi, Kochi
TEL
0889-43-2121
satsukikai@susaki-kuroshio-hp.or.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsushita |
Organization
Kochi University Faculty of Medicine
Division name
Lecture room of Neurology
Zip code
783-0043
Address
Kohasu, Okouchou, Nankoku-shi, Kochi
TEL
0888-88-2749
Homepage URL
im71@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kochi University Faculty of Medicine
Address
Kohasu, Okouchou, Nankoku-shi, Kochi
Tel
0888-88-2749
im71@kochi-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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 21 | 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
36
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
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | 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 | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055160
