UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059128 |
|---|---|
| Receipt number | R000067637 |
| Scientific Title | Relationship between Hand Function and Perceived Difficulty in Activities of Daily Living in Patients Undergoing Hemodialysis |
| Date of disclosure of the study information | 2025/09/19 |
| Last modified on | 2025/09/18 21:44:12 |
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Basic information
Public title
Relationship between Hand Function and Perceived Difficulty in Activities of Daily Living in Patients Undergoing Hemodialysis
Acronym
Relationship between Hand Function and Perceived Difficulty in Activities of Daily Living in Patients Undergoing Hemodialysis
Scientific Title
Relationship between Hand Function and Perceived Difficulty in Activities of Daily Living in Patients Undergoing Hemodialysis
Scientific Title:Acronym
Relationship between Hand Function and Perceived Difficulty in Activities of Daily Living in Patients Undergoing Hemodialysis
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relationship between hand function and difficulty in activities of daily living in patients undergoing hemodialysis
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perceived difficulty in activities of daily living
Key secondary outcomes
Grip Strength
Elbow Flexion Strength
Lateral Pinch Strength
Fingertip-to-Palm Distance
Sensory Disturbance
Mallet Finger
Trigger Finger
Manual Dexterity
Knee Extension Strength
Single-Leg Standing Time
Body Composition
Quality of Life
Activities of Daily Living
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Maintenance hemodialysis patients
Key exclusion criteria
1.Individuals who are unable to maintain a standing position
2.Individuals who have difficulty walking
3.Individuals with a history of kidney transplantation
4.Individuals with a history of upper limb fracture
5.Individuals who have received chemotherapy
6.Individuals with central nervous system disorders causing motor paralysis
7.Individuals who are unable to respond appropriately to questionnaires due to dementia or visual impairment
8.Individuals with a pacemaker
9.Individuals deemed inappropriate for inclusion in this study by their attending physician
10.Individuals who do not provide informed consent for participation in this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9608516
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
TEL
0245815503
morishit@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Morishita |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
9608516
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
TEL
0245815503
Homepage URL
morishit@fmu.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
10-6 Sakae-machi, Fukushima-city, Fukushima, Japan
Tel
0245815503
morishit@fmu.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
若松あおいクリニック（福島県）、喜多方腎泌尿器クリニック（福島県）、すずきクリニック（福島県）、あさか野泌尿器透析クリニック（福島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2029 | Year | 03 | Month | 31 | Day |
Other
Other related information
Now in progress
Management information
Registered date
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067637
