UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Short-term effect of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders
Title of the study (Brief title)	Intensive physiotherapy rehabilitation on neurodegenerative disorders
Region	Japan

Condition
Condition	Parkinson's disease, multiple system atrophy, spinocerebellar degeneration, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate short-term effectiveness of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Time of up and go test MDS-UPDRS
Key secondary outcomes	Time of 10 minutes walk Power of hip joint flexure muscle Functional reach test Time of standing on one leg Respiratory functions (%FVC and FEV1.0%) SF-36 MDS-UPDRS subscale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	No treatment
Interventions/Control_2	Voluntary training
Interventions/Control_3	Manual resistive exercise
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	Inpatient who was admitted in order to confirm the diagnosis
Key exclusion criteria	1) Medical history of any other physical illness which can affect on motor functions 2) Activity is limited by cardiopulmonary dysfunction 3) Pregnant 4) Patient who perform any rehabilitation within 1 week before admission
Target sample size	270

Research contact person
Name of lead principal investigator	Koji Abe
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Neurology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	086-235-7365
Email	abekabek@cc.okayama-u.ac.jp

Public contact
Name of contact person	Kota Sato
Organization	Okayama University hospital
Division name	Department of Neurology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	086-235-7365
Homepage URL
Email	kosatou@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 02 Month 17 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry	2019 Year 03 Month 01 Day
Date trial data considered complete	2019 Year 03 Month 01 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023723