UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052264 |
|---|---|
| Receipt number | R000059663 |
| Scientific Title | A multicenter randomized controlled trial of goal attainment scaling for functional goals in home-based physical therapy |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/03/24 16:52:54 |
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Basic information
Public title
Effectiveness of goal attainment scaling for functional goals in home-based physical therapy
Acronym
Effectiveness of goal attainment scaling in home-based physical therapy
Scientific Title
A multicenter randomized controlled trial of goal attainment scaling for functional goals in home-based physical therapy
Scientific Title:Acronym
A randomized controlled trial of goal attainment scaling for functional goals in home-based physical therapy
Region
| Japan |
Condition
Condition
cerebrovascular disease, bone and joint diseases
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of using goal attainment scaling on activities and participation in home-based physical therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Barthel Index (3 months, 6 months 9 months and 1 year after the start of intervention)
Key secondary outcomes
Frenchay Activities Index
The performance qualifier of the ICF in domestic life (d6) and community, social and civic life (d9)
Life-space Assessment
Rivermead Mobility Index
Subjective life satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using goal attainment scaling on activities and participation in home-based physical therapy management over 1 Year (intervention group)
Interventions/Control_2
Regular home-based physical therapy management, not use goal attainment scaling, over 1 year (control group)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Newly enrolled home-based physical therapy
Main disease that caused the use of home-based physical therapy is cerebrovascular disease or bone and joint diseases
Level of care requirements 1-5 under long-term insurance system
Key exclusion criteria
Concomitant with malignancy, progressive neurological disease, dementia due to degenerative diseases of the central nervous system, including Alzheimer's disease and dementia with Lewy bodies, mental disorders, and congenital pediatric diseases
Severe dementia that prevented their provision of consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Kamioka |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-cho, Inashiki-gun, Ibaraki
TEL
029-888-4000
ykamioka@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Kamioka |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
300-0394
Address
4669-2 Ami, Ami-cho, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
ykamioka@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethical review committee of Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-cho, Inashiki-gun, Ibaraki 300-0394
Tel
029-888-4000
kyoumu@ipu.ac.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
| 2024 | Year | 01 | Month | 01 | 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
| 2023 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
