UMIN-CTR Clinical Trial

Basic information
Public title	The effect of combined psychotherapy and exercise therapy on the improvement of upper limb motor function A systematic review of randomized controlled trials
Acronym	The effect of combined psychotherapy and exercise therapy on the improvement of upper limb motor function A systematic review of randomized controlled trials
Scientific Title	The effect of combined psychotherapy and exercise therapy on the improvement of upper limb motor function A systematic review of randomized controlled trials
Scientific Title:Acronym	The effect of combined psychotherapy and exercise therapy on the improvement of upper limb motor function A systematic review of randomized controlled trials
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of the combination of psychotherapy and exercise therapy on the improvement of upper limb motor function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of upper limb motor function
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who have been diagnosed with cerebral hemorrhage or cerebral infarction 2. Patients who received psychological intervention in addition to exercise therapy for upper limbs. 3. The control group is conventional treatment (only exercise therapy for upper limbs) 4. The study was designed as a randomized controlled trial
Key exclusion criteria	Those who have been diagnosed with subarachnoid hemorrhage
Target sample size

Research contact person
Name of lead principal investigator	1st name Yuji Middle name Last name Iwamoto
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8524
Address	1-1-1 kagamiyama, Higashi-Hiroshima City, Hiroshima, JAPAN
TEL	+818056216171
Email	yuji_ooooot@yahoo.co.jp

Public contact
Name of contact person	1st name Yuji Middle name Last name Iwamoto
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8524
Address	1-1-1 kagamiyama, Higashi-Hiroshima City, Hiroshima, JAPAN
TEL	+818056216171
Homepage URL
Email	yuji_ooooot@yahoo.co.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	N/A
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	N/A
Address	N/A
Tel	N/A
Email	N/A

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	2021 Year 08 Month 23 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	2021 Year 08 Month 20 Day
Date of IRB	2022 Year 08 Month 01 Day
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	N/A

Management information
Registered date	2021 Year 08 Month 23 Day
Last modified on	2022 Year 08 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051661