UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060027 |
|---|---|
| Receipt number | R000068356 |
| Scientific Title | Severity-Based Kinematic Analysis of Paretic and Non-Paretic Hand Function in Post-Stroke Hemiparesis: A Pilot Study for Developing a Novel Occupational Therapy |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 14:29:10 |
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Basic information
Public title
Severity-Based Kinematic Analysis of Paretic and Non-Paretic Hand Function in Post-Stroke Hemiparesis: A Pilot Study for Developing a Novel Occupational Therapy
Acronym
A Study Analyzing Hand Movements in Stroke Patients to Develop New Rehabilitation Approaches
Scientific Title
Severity-Based Kinematic Analysis of Paretic and Non-Paretic Hand Function in Post-Stroke Hemiparesis: A Pilot Study for Developing a Novel Occupational Therapy
Scientific Title:Acronym
Severity based Paretic Hand Movement Study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze the kinematics of grasping movements in patients with post-stroke hemiparesis using 3D motion analysis to clarify the characteristics of finger movements according to severity.
Basic objectives2
Others
Basic objectives -Others
Based on the obtained data, we aim to create a clinically applicable standard motion model to serve as a foundation for designing rehabilitation protocols.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Kinematic parameters calculated based on 3D coordinate data extracted by HandSense:
Time-series joint angles (Flexion/extension angles of thumb MP/IP joints and finger PIP/DIP joints)
Inter-finger distance (Time-series changes in distance between the thumb and each finger tip, timing and magnitude of preshaping formation)
Key secondary outcomes
Movement time (Total time from start to end of the movement and time for each phase)
Smoothness (Jerk calculated from the velocity profile of finger coordinate data)
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
Adults aged 18 years or older
Patients diagnosed with stroke (cerebral hemorrhage or infarction) of first onset
Patients capable of maintaining a sitting position independently
Patients capable of participating in the measurement task using the paretic fingers
Key exclusion criteria
Patients with difficulty understanding the research explanation and instructions due to cognitive decline (MMSE score of 23 or less)
Patients with a Fugl-Meyer Assessment Upper Extremity (FMA-UE) score of 28 or less (Severe impairment group)
Patients with a history of surgery on the fingers or forearm
Patients with neurological or musculoskeletal diseases affecting the movement of the fingers or forearm
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hideto |
| Middle name | |
| Last name | Tobishima |
Organization
Medical Corporation Keiaikai Rehabilitation Amakusa Hospital
Division name
Rehabilitation Department
Zip code
343-0002
Address
Hirakata, Koshigaya City, Saitama Prefecture343-1
TEL
0489741171
2781305q@spu.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Tobisima |
Organization
Saitama Prefectural University
Division name
Master's Program in Rehabilitation Studies
Zip code
278-0038
Address
2-7-10 Tsutsumino, Noda City, Chiba Prefecture
TEL
09038056146
Homepage URL
2781305q@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural University
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
Medical Corporation Keiaikai Rehabilitation Amakusa Hospital
Address
Hirakata, Koshigaya City, Saitama Prefecture343-1
Tel
0489741171
2781305q@spu.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 | 12 | Month | 09 | 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
| 2025 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was approved by the Ethics Review Committee of Keiai Medical Corporation Amakusa Rehabilitation Hospital on August 20, 2025 (approval number: 20250820). The study is scheduled to run from October 2025 to August 2026, and data collection is currently underway.
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068356
