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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035163
Receipt No. R000040076
Official scientific title of the study Effects of postural deformity on gait in Parkinson's disease
Date of disclosure of the study information 2018/12/07
Last modified on 2018/12/07

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Basic information
Official scientific title of the study Effects of postural deformity on gait in Parkinson's disease
Title of the study (Brief title) Postural deformity and gait in 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 investigate the effects of postural deformity on gait in Parkinson's disease
Basic objectives2 Others
Basic objectives -Others We investigate the relationship between posture deformity and gait and help to develop effective rehabilitation programs.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Kinematic,kinetic and spatiotemporal prameters of sitting,standing and walking
Key secondary outcomes New Freezing of Gait Questionnaire
Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
Maximal isometric muscle strength

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.diagnosis of Parkinson's disease
2.walking ability for a short distance(10m) without use of device
Key exclusion criteria 1.history of other neurological disorders,severe orthopedic disease of lower limb and cardiovascular disease
2.difficulty understanding instructions
Target sample size 20

Research contact person
Name of lead principal investigator Hideyuki Urakami
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Address 2-7,College-cho,Takatsuki-shi,Osaka 569-8686
TEL 072-683-1221
Email reh096@osaka-med.ac.jp

Public contact
Name of contact person Hideyuki Urakami
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Address 2-7,College-cho,Takatsuki-shi,Osaka 569-8686
TEL 072-683-1221
Homepage URL
Email reh096@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization No funding source
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 大阪医科大学附属病院(大阪府)、畿央大学(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 07 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information We investigate the effects of postural deformity on gait in Parkinson's disease.

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040076

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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