UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047647 |
|---|---|
| Receipt number | R000054306 |
| Scientific Title | The effect of Positive feedback on the forward reach ability in older people with convalescent rehabilitation ward: randomized controlled trial |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2024/09/12 00:32:12 |
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Basic information
Public title
The effect of Positive feedback on the forward reach ability in older people with convalescent rehabilitation ward: randomized controlled trial
Acronym
The effect of Positive feedback on the forward reach ability in older people with convalescent rehabilitation ward
Scientific Title
The effect of Positive feedback on the forward reach ability in older people with convalescent rehabilitation ward: randomized controlled trial
Scientific Title:Acronym
The effect of Positive feedback on the forward reach ability in older people with convalescent rehabilitation ward
Region
| Japan |
Condition
Condition
Older people who admitted the convalescent rehabilitation unit
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of positive feedback intervention on forward reach ability of older patients in a convalescent rehabilitation ward
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change from baseline in the Functional Reach Test (FRT) score after the 5-week intervention
Key secondary outcomes
The secondary outcomes are the change from baseline in the Short Falls Efficacy Scale International score and the Functional Independence Measure after the 5-week intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Positive feedback interventional with usual rehabilitation
FRT will be performed on the experimental group and positive feedback will be given on the results. The intervention is once every 3 days and will be conducted 12 times during the 5-week intervention period. Participants receive approximately 2 to 3 hours of usual rehabilitation consisting of physical therapy, occupational therapy, or speech therapy daily.
Interventions/Control_2
Usual rehabilitation only
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients admitted to a convalescent rehabilitation ward
2) Patients who are able to hold a standing position alone without the use of supports
3) Patients with Mini-Mental State Examination-Japanese score of 24 or more
4) Patients with FRT less than 18.5 cm
5) Patients with written informed consent prior to participation
Key exclusion criteria
1) Patients with upper limb paralysis that makes testing difficult
2) Patients with current life-threatening severe organ failure, or musculoskeletal disorders
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | uchida |
Organization
Kurashiki Heisei Hospital
Division name
Department of Rehabilitation
Zip code
710-0826
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
TEL
086-427-1111
hiroyukiuchida02@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Kurashiki Heisei Hospital
Division name
Department of Rehabilitation
Zip code
710-0826
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
TEL
086-427-1111
Homepage URL
hiroyukiuchida02@gmail.com
Sponsor or person
Institute
Kurashiki Heisei Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Kurashiki Heisei Hospital
Address
4-3-38 Oimatsu-cho, Kurashiki-shi, Okayama
Tel
086-427-1111
hiroyukiuchida02@gmail.com
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
| 2022 | Year | 05 | Month | 31 | 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
32
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
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054306
