UMIN-CTR Clinical Trial

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
Email	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
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047234