UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041373 |
|---|---|
| Receipt number | R000047234 |
| Scientific Title | Relationship between falls in Parkinson's disease patients and freezing feet in clinical and home situations |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/10 12:55:43 |
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Basic information
Public title
Relationship between falls in Parkinson's disease patients and freezing feet in clinical and home situations
Acronym
Relationship between falls in Parkinson's disease patients and freezing feet in clinical and home situations
Scientific Title
Relationship between falls in Parkinson's disease patients and freezing feet in clinical and home situations
Scientific Title:Acronym
Relationship between falls in Parkinson's disease patients and freezing feet in clinical and home situations
Region
| Japan |
Condition
Condition
Parkinson's disease patients using life-stage rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of FOG in rehabilitation and home-based situations on falls in patients with Parkinson's disease who use life-phase rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Basic information
Target: Age, gender, main disease name, rehabilitation type (outpatient/outpatient)
Frequency of use (times/week), period from start of use
2.Physical/cognitive function evaluation
Disease severity: Hoehn-Yahr classification
Unified Parkinson's Disease Rating Scale Exercise Items
Gait function evaluation: 10m walking
Functional Mobility Assessment: Timed Up & Go Test
Cognitive Function Assessment: Functional Assessment Staging
3.FOG evaluation
FOG Severity: New Freezing Of Gait Questionnaire
Number of FOGs: FOGs in rehabilitation and home situations are measured with an accelerometer (3-axis acceleration sensor)
Fall history for the last 6 months
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Parkinson's disease who are using life-stage rehabilitation at each research cooperation facility
Key exclusion criteria
1.A person with a history of falls and cognitive impairment that makes it difficult to wear or manage an accelerometer
2.A person who is at stage 5 (slightly deteriorated cognitive function) or higher in the functional assessment staging.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kousuke |
| Middle name | |
| Last name | Hirata |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0738351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Kousuke |
| Middle name | |
| Last name | Hirata |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Koriencho, Hirakata City, Osaka
TEL
0728351010
Homepage URL
https://kawaguchi-ns.com
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Koriencho, Hirakata City, Osaka
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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
川口脳神経外科リハビリクリニック（大阪府）、西大和リハビリテーション病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 10 | 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
| 2020 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The accelerometer uses a 3-axis accelerometer (AX3, manufactured by Axivity) and is attached to the subject's fifth lumbar spine posteriorly with a belt.
Management information
Registered date
| 2020 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047234
