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
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
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
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
