UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045223
Receipt number R000051661
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
Date of disclosure of the study information 2021/08/23
Last modified on 2022/08/23 02:07:07

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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 or person

Institute

Hiroshima University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051661


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name