UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044582
Receipt number R000050921
Scientific Title The effect of Home-based task-oriented training with Playball for community-dwelling elderly who have had a stroke with lower limb disability: Multicenter Randomized Controlled Trial
Date of disclosure of the study information 2021/06/18
Last modified on 2023/12/19 12:22:07

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Basic information

Public title

The effect of Home-based task-oriented training with Playball for community-dwelling elderly who have had a stroke with lower limb disability: Multicenter Randomized Controlled Trial

Acronym

The effect of Home-based task-oriented training with Playball for stroke patients

Scientific Title

The effect of Home-based task-oriented training with Playball for community-dwelling elderly who have had a stroke with lower limb disability: Multicenter Randomized Controlled Trial

Scientific Title:Acronym

The effect of Home-based task-oriented training with Playball for stroke patients

Region

Japan


Condition

Condition

stroke

Classification by specialty

Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of Home-based task-oriented training with Playball for stroke patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Short physical performance battery at 3 months (post intervention)

Key secondary outcomes

Berg Balance Scale at 3 months (post intervention)
Functional independence measure; FIM at 3 months (post intervention)
Lawton IADL at 3 months (post intervention)
Chair stand-30 at 3 months (post intervention)
5 sit-to-stand test at 3 months (post intervention)
Gait speed at 3 months (post intervention)
Grip strength at 3 months (post intervention)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

The Home-based task-oriented training with Playball
once or twice a week
60 minutes session
3 months

Interventions/Control_2

The equal-dose conventional physical therapy
once or twice a week
60 minutes session
3 months

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patient with lower limb disability due to stroke
2)MMSE score over 18

Key exclusion criteria

1)Decreased cognitive function (MMSE score under 19)
2)Poorly controlled medical conditions
3) Prohibition by the physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Kurakata

Organization

DOTLINE Inc

Division name

Department of medical and nursing care

Zip code

260-0015

Address

Chiba-Fujimi LK building 2F 2-19-7 Fujimi Chuo-ku, Chiba-shi, Chiba-ken Japan

TEL

043-307-5095

Email

hir.kurakata@dotline-jp.com


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Kurakata

Organization

DOTLINE Inc

Division name

Department of medical and nursing care

Zip code

260-0015

Address

Chiba-Fujimi LK building 2F 2-19-7 Fujimi Chuo-ku, Chiba-shi, Chiba-ken Japan

TEL

043-307-5095

Homepage URL


Email

hir.kurakata@dotline-jp.com


Sponsor or person

Institute

DOTLINE Inc
Department of medical and nursing care

Institute

Department

Personal name



Funding Source

Organization

DOTLINE Inc

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Chiba Physical Therapy Association

Address

#1005, Chiba-chuo twin building 1, Chiba-shi, Chiba-ken Japan

Tel

043-301-3065

Email

chiba-rpt@crest.ocn.ne.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

2021 Year 06 Month 18 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

59

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Our study has not yet been accepted by any medical journal.

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

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 03 Day

Date of IRB

2021 Year 06 Month 10 Day

Anticipated trial start date

2021 Year 06 Month 21 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 17 Day

Last modified on

2023 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050921


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name