UMIN-CTR Clinical Trial

Basic information
Public title	Quantification of anticipatory postural adjustments evaluation using smartphone
Acronym	Quantification of anticipatory postural adjustments evaluation using smartphone
Scientific Title	Quantification of anticipatory postural adjustments evaluation using smartphone
Scientific Title:Acronym	Quantification of anticipatory postural adjustments evaluation using smartphone
Region	Japan

Condition
Condition	control, patients with Parkinson's disease, patients with stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Quantification of anticipatory postural adjustments evaluation using smartphone
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	acceleration
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	45 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Regarding the recruitment of the participants, the patients with PD and stroke were selected from the outpatients of our rehabilitation facility, and the healthy elderly controls with no medical history were recruited from around our neighborhood. The inclusion criteria required participants in each group to be capable of unassisted walking, have a score of at least 24 on the Mini-Mental State Examination (MMSE), and be free of marked limited range of motion of the ankles.
Key exclusion criteria	People unable to readily understand the task, people with a visual disorder, and people with sensory impairments were excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Sakai
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Rehabilitation Medicine
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	0338136111
Email	t_sakai.orth@tmd.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Onuma
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Rehabilitation Medicine
Zip code	349-0142
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	+81487652525
Homepage URL
Email	1781301r@spu.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University Graduate School
Institute
Department

Funding Source
Organization	Other
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	Tokyo Medical and Dental University Graduate School
Address	1-5-45 Yushima Bunkyo-ku Tokyo
Tel	+818012104673
Email	1781301r@spu.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	2024 Year 03 Month 31 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	Preinitiation
Date of protocol fixation	2021 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 13 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Before the start

Management information
Registered date	2021 Year 04 Month 13 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050143