UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061105 |
|---|---|
| Receipt number | R000069924 |
| Scientific Title | The effect of a Positive feedback intervention on changes in standing forward reach ability among hospitalized older adults: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/04/17 22:45:42 |
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Basic information
Public title
The effect of a Positive feedback intervention on changes in standing forward reach ability among hospitalized older adults: A pilot randomized controlled trial
Acronym
The effect of a Positive feedback intervention on changes in standing forward reach ability among hospitalized older adults
Scientific Title
The effect of a Positive feedback intervention on changes in standing forward reach ability among hospitalized older adults: A pilot randomized controlled trial
Scientific Title:Acronym
The effect of a Positive feedback intervention on changes in standing forward reach ability among hospitalized older adults
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
The purpose of this trial is to preliminaryly investigate the effectiveness of positive feedback on changes in standing forward reach ability in older patients hospitalized in a convalescent rehabilitation unit.
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 to 5 weeks after intervention in standing forward reach ability, as measured by the Functional Reach Test (FRT).
Key secondary outcomes
Secondary outcomes include changes from baseline in the 10-meter walk test (10mWT) and the Short Falls Efficacy Scale International (Short FES-I) following the 5-week intervention, as well as the incidence of adverse events (AEs) during the intervention period.AEs are defined as deaths, life-threatening illnesses, injuries requiring prolonged hospitalization, or injuries resulting in permanent disability that occur during the study period; all such events are included, regardless of whether a causal relationship with the intervention exists.
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 Intervention for standing forward reach ability
In the experimental group, FRT will be performed during the 5-week intervention period, and positive feedback will be provided based on the results. The intervention will take place once every three days, for a total of 12 sessions during the intervention period.
Interventions/Control_2
Assessment of standing forward reach ability only
The control group will also perform FRT during the 5-week intervention period. However, no positive feedback will be provided regarding the results. The intervention will take place once every three days, for a total of 12 sessions during the intervention period.
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients admitted to a convalescent rehabilitation ward
2) Patients capable of maintaining an upright position independently without the use of assistive devices
3) Patients with sufficient cognitive function to understand the study protocol
4) Patients with an FRT of less than 18.5 cm
5) Patients who provide written informed consent prior to participation
Key exclusion criteria
1) Patients with upper limb paralysis severe enough to make the examination difficult
2) Patients currently suffering from 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
710-0837
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
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
710-0837
Address
4-3-38 Oimatsucho, Kurashiki-city, Okayama Japan
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
岡山
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2026 | Year | 03 | Month | 30 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069924
