UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049991 |
|---|---|
| Receipt number | R000056934 |
| Scientific Title | A Study on intervention program to improve grasping force control ability in hemiplegic stroke patients |
| Date of disclosure of the study information | 2023/01/08 |
| Last modified on | 2024/07/10 11:20:49 |
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Basic information
Public title
A Study on intervention program to improve grasping force control ability in hemiplegic stroke patients
Acronym
A Study on intervention program to improve grasping force control ability in hemiplegic stroke patients
Scientific Title
A Study on intervention program to improve grasping force control ability in hemiplegic stroke patients
Scientific Title:Acronym
A Study on intervention program to improve grasping force control ability in hemiplegic stroke patients
Region
| Japan |
Condition
Condition
Patients with cerebrovascular disorder
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effect of the intervention program on grasping force control ability in stroke patients using a grasp force control task.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Error in target grasping force and measured grasping force
Key secondary outcomes
FIM
Grip strength
Action Research Arm Test(ARAT)
Fugl-Meyer Assessment(FMA)
Motor Activity Log(MAL)
Visuospatial function(Rey-Osterrieth Complex Figure Test)
Ten Item Personality Inventory(TIPI)
Intrinsic Motivation Inventory(IMI)
Self-efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Grasping force control practice using grasping force control task (15 trials, 30 seconds per trial. one day only)
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
1) Understand oral instructions
2) No pain in fingers
3) Brunnstrom recovery stage 4 and above
4) The wrist joint on the paralyzed side can be extended by 20 or more at will.
5) The IP and MP joints of the paralyzed side 1 to 3 fingers can be extended by 10 or more.
6) The sitting position is stable
Key exclusion criteria
1) Have experience of performing similar tasks in the past
2) Have a current or history of orthopedic or neurological disorders of the fingers that may interfere with life on the non-paralyzed side
3) Significant aphasia, attention disorder, hemilateral visual space neglect, cognitive dysfunction
4) Patients who cannot see the monitor
5) There are serious complications that are not medically controlled
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Yabuki |
Organization
Mejiro University
Division name
Department of Physical Therapy
Zip code
3398501
Address
Ukiya-320, Iwatsukiku, Saitama city, Saitama, Japan
TEL
048-797-2152
j.yabuki@mejiro.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yabuki |
Organization
Mejiro University
Division name
Department of Physical Therapy
Zip code
3398501
Address
Ukiya-320, Iwatsukiku, Saitama city, Saitama, Japan
TEL
048-797-2152
Homepage URL
j.yabuki@mejiro.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number JP 22H04417
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
Mejiro University
Address
Ukiya-320, Iwatsukiku, Saitama city, Saitama, Japan
Tel
048-797-2152
j.yabuki@mejiro.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
| 2023 | Year | 01 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2024.7.10 Recruitment continues.
Management information
Registered date
| 2023 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056934
