UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059318 |
|---|---|
| Receipt number | R000067851 |
| Scientific Title | Comparison of a Novel Assistive Device and Conventional Handrails for Toileting Activities in Patients with Hemiparesis after Stroke: A Single-Group Comparative Study. |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/10/07 20:45:26 |
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Basic information
Public title
Comparison of a Novel Assistive Device and Conventional Handrails for Toileting Activities in Patients with Hemiparesis after Stroke: A Single-Group Comparative Study.
Acronym
Comparison of a Novel Assistive Device and Conventional Handrails for Toileting Activities in Patients with Hemiparesis after Stroke.
Scientific Title
Comparison of a Novel Assistive Device and Conventional Handrails for Toileting Activities in Patients with Hemiparesis after Stroke: A Single-Group Comparative Study.
Scientific Title:Acronym
Comparison of a Novel Assistive Device and Conventional Handrails for Toileting Activities in Patients with Hemiparesis after Stroke.
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of a novel assistive device compared with conventional handrails on toileting performance and caregiver burden in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
center of the foot pressure
Key secondary outcomes
Numerical rating scale
Surface electromyography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Berg Balance Scale on the standing maintenance item: 0 point
2. FIM on lower body dressing: 1 point
3. A person who has hemiplegia
Key exclusion criteria
1. persons who have bilateral paralysis
2. persons who have a history of neuromuscular disease affecting standing or balance
3. persons who have difficulty understanding movement instructions
4. persons who have contraindications to chest compression
5. persons who have skin fragility
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
D.sawamura@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
0117063387
Homepage URL
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Naka corporation
Name of secondary funder(s)
Naka corporation
IRB Contact (For public release)
Organization
Ethical review board of Faculty of Health Sciences, Hokkaido University
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
Tel
0117063316
shomu@hs.hokudai.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
| 2025 | Year | 11 | Month | 10 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study examines the effectiveness of a novel assistive device compared with a conventional handrail. During each condition, a caregiver assists patients with stroke in the donning and doffing of lower garments while the patients maintain a standing posture. The evaluation measures include center of pressure (COP) parameters, perceived exertion and discomfort assessed by the Numerical Rating Scale (NRS), surface electromyography (sEMG) of relevant muscles, task completion time, and video recordings for observational analysis.
Management information
Registered date
| 2025 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067851
