UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054938 |
|---|---|
| Receipt number | R000062763 |
| Scientific Title | Effect of upper limb movement on the nonparalyzed side on reducing edema in the paralyzed hand |
| Date of disclosure of the study information | 2024/07/11 |
| Last modified on | 2025/04/11 14:47:37 |
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Basic information
Public title
Effect of upper limb movement on the nonparalyzed side on reducing edema in the paralyzed hand
Acronym
Reduction of edema of paralyzed hand by exercise of the paralyzed side upper limb
Scientific Title
Effect of upper limb movement on the nonparalyzed side on reducing edema in the paralyzed hand
Scientific Title:Acronym
Reduction of edema of paralyzed hand by exercise of the paralyzed side upper limb
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the edema reduction effect by applying the venous return enhancement effect of handgrip exercise on the paralyzed upper limb of the non-paralyzed side as a clinical practice verification, and to elucidate factors related to edema based on quantitative evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume of hand edema and venous return of the upper extremities
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1) In this study, the BAB method research design will be used, with Period B being the intervention period and Period A being the normal training period.
2) Both Period B and Period A will be 8 days in duration; Period B, Period A, and Period B will be a total of 24 days in duration.
3) In Phase B, handgrip exercises by the non-paralyzed side will be introduced as part of the normal training. The handgrip exercise load is 30% of the maximum grip strength. The duration of the exercise should be 30 seconds with a 30-second rest period, i.e., five sets of five minutes.
4) Edema of the hand and upper limb will be measured by a hand volumeter and bioelectrical impedance method. The hand volumetric meter measurement will be performed on the day before the introduction of the handgrip exercise and after each occupational therapy session, i.e., 25 times in total. The bioelectrical impedance measurement will be performed on the day before the experiment and on the last day of each period. Edema was measured bilaterally.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
more than 3 months after stroke onset, motor paralysis of the hand, edema of the hand
Key exclusion criteria
Cardiac disease
cardiac surgery, a pacemaker, a history of pulmonary embolism, respiratory disease
Pacemaker, history of pulmonary embolism, respiratory disease
history of pulmonary embolism, history of
Respiratory disease
Exercise is restricted or prohibited by the attending physician.
Has difficulty understanding instructions for bed rest or exercise, or has difficulty following instructions even if he/she can understand them.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh university
Division name
Faculty of care and rehabilitation
Zip code
4768588
Address
2-172 Fukinodai, Tokai City, Aichi
TEL
0526016000
hayashi-h@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Seijoh University
Division name
Faculty of care and rehabilitation
Zip code
4768588
Address
2-172 Fukinodai, Tokai City, Aichi
TEL
0526016000
Homepage URL
hayashi-h@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University, Faculty of care and rehabilitation
Institute
Department
Personal name
Hayashi Hiroyuki
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai City, Aichi
Tel
0526016000
kenkyu-entry@seijoh-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 | 07 | Month | 11 | 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
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062763
