UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055700 |
|---|---|
| Receipt number | R000063647 |
| Scientific Title | A Comparative Interventional Study on the Effect of Progress Visualization Based on Self-recording in Outpatient Rehabilitation Patients on the Continuation of Home-based Self-rehabilitation |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2025/04/04 09:56:26 |
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Basic information
Public title
A Study on the Impact of Monitoring Rehabilitation Progress on the Continuation of Home-based Rehabilitation
Acronym
Rehabilitation Progress and Continuation Study
Scientific Title
A Comparative Interventional Study on the Effect of Progress Visualization Based on Self-recording in Outpatient Rehabilitation Patients on the Continuation of Home-based Self-rehabilitation
Scientific Title:Acronym
RCT on Progress Visualization and Rehabilitation Continuation
Region
| Japan |
Condition
Condition
Orthopedic Disorders (Postoperative or Under Conservative Therapy)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the impact of self-recording and progress visualization on the continuation of home-based self-rehabilitation in outpatient rehabilitation patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether or not home-based self-rehabilitation was continued (Assessment timing: 3 months after the start of the trial)
Key secondary outcomes
Changes in joint range of motion and muscle strength (Assessment timing: at the start of the trial and 3 months after)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
| Behavior,custom |
Interventions/Control_1
In the intervention group, patients self-record the number of voluntary rehabilitation sessions on a recording sheet, and a research assistant will follow up with the patients during weekly outpatient visits.
At the follow-up, a bar graph of the cumulative number of times will be created using Excel based on the recording paper.
This graph is intended to provide visual feedback on the patient's rehabilitation progress. The intervention period is one month, with follow-ups occurring once a week.
Interventions/Control_2
In the control group, patients will self-record the number of home-based rehabilitation sessions on a provided log sheet, but progress visualization (creating and providing graphs) will not be conducted.
The intervention period is 3 months, and during weekly outpatient visits, the research staff will review the rehabilitation records without providing any graphical feedback.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients attending Konan Medical Center for orthopedic disorders.
2.Patients who have undergone surgery for orthopedic disorders or are undergoing conservative therapy.
3.Age between 50 and 80 years at the time of consent.
4.Patients who have received instructions for home-based self-rehabilitation from an orthopedic surgeon and a physical therapist (PT) at Konan Medical Center.
5.Patients who are able to voluntarily consent to participate in this study.
Key exclusion criteria
1.Patients with Alzheimers disease, dementia, or other cognitive impairments requiring treatment
2.Patients with severe mental disorders requiring treatment, such as major depression or schizophrenia
3.Patients with severe comorbidities such as heart failure NYHA class III or IV, renal failure eGFR less than 30 mL per min per 1.73 square meters, or respiratory diseases predicted value less than 50 percent in lung function tests
4.Patients with systemic diseases such as rheumatoid arthritis that restrict movement
5.Patients with infections or other complications at the surgical site
6.Patients participating in other research studies that may interfere with this studys rehabilitation intervention
7.Any other patients deemed unsuitable by the study investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Muragaki |
Organization
Kobe University
Division name
Graduate School of Medicine, Department of Biomedical Engineering
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5342
muragaki@people.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Tagawa |
Organization
Graduate School of Kobe University
Division name
Graduate School of Medicine, Department of Biomedical Engineering
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5342
Homepage URL
233m107m@stu.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Kotaro Tagawa
Funding Source
Organization
Kobe University
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
Organization Name: Kobe University, Clinical and Translational Research Promotion Center, IRB Office
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
kainyu@med.kobe-u.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 | 10 | Month | 02 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063647
