UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048736 |
|---|---|
| Receipt number | R000054970 |
| Scientific Title | Determination of Minimum Clinically Important Difference (MCID) in outcome measures specific to spinal cord injury patients |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2025/03/18 22:33:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Determination of Minimum Clinically Important Difference (MCID) in outcome measures specific to spinal cord injury patients
Acronym
Determination of Minimum Clinically Important Difference (MCID) in outcome measures specific to spinal cord injury patients
Scientific Title
Determination of Minimum Clinically Important Difference (MCID) in outcome measures specific to spinal cord injury patients
Scientific Title:Acronym
MCID study of SCI
Region
| Japan |
Condition
Condition
Spinal cord injuries
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to contribute to the development of various clinical trials by determing the MCID of various outcome measures specific to spinal cord injuries(SCI) and showing important indicators of change in SCI.
Basic objectives2
Others
Basic objectives -Others
Determing the MCID of various outcome measures specific to spinal cord injuries.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The American Spinal Injury Association Impairment Scale(AIS), Upper Extremity Motor Score(UEMS), Lower Extremity Motor Score(LEMS), The Graded Redefined Assessment of Strength, Sensation and Prehension Ver.2.0(GRASSP), Action Research Arm Test(ARAT),Spinal cord independence measure(SCIM), Clinical Trunk control test in individuals with SCI(CTCT), Global Rating of Change(GROC).
Implementation at the timing of 1 month, 2 months, 3 months from the initial evaluation.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Traumatic or non-traumatic complete / incomplete spinal cord injury patients within 9 months of injury.
Key exclusion criteria
Subjects who affected by physical dysfunction other than spinal cord injury.
Subjects who have difficulty understanding the test instructions due to deterioration of cognitive and mental functions.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Jimbo |
Organization
Chiba Rehabilitation Center
Division name
Department of Rehabilitation Therapy
Zip code
2660005
Address
1-45-2,Hondacho,Midori-Ku,Chiba266-0005,JAPAN
TEL
0432911831
kazumasa.jinbo@chiba-reha.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Iwaida |
Organization
Chiba Rehabilitation Center
Division name
Department of General Affairs
Zip code
2660005
Address
1-45-2,Hondacho,Midori-Ku,Chiba266-0005,JAPAN
TEL
0432911831
Homepage URL
kaori.iwaida@chiba-reha.jp
Sponsor or person
Institute
Chiba Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
千葉県千葉リハビリテーションセンター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 24 | 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
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 07 | 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
Subjects:Subjects who affected by physical dysfunction other than spinal cord injury.
Subjects who have difficulty understanding the test instructions due to deterioration of cognitive and mental functions.
Methods:The American Spinal Injury Association Impairment Scale(AIS), Upper Extremity Motor Score(UEMS), Lower Extremity Motor Score(LEMS), The Graded Redefined Assessment of Strength, Sensation and Prehension Ver.2.0(GRASSP), Action Research Arm Test(ARAT),Spinal cord independence measure(SCIM), Clinical Trunk control test in individuals with SCI(CTCT), Global Rating of Change(GROC).
Implementation at the timing of 1 month from the initial evaluation.
Traumatic or non-traumatic complete / incomplete spinal cord injury patients within 9 months of injury.
Statistical analysis: Classify GROC improved and non-improved groups into groups at initial rating and at 1 month. Depending on the distribution of data, the MCID of each outcome measures is calculated based on the receiver operating characteristic (ROC) curve or method using logistic regression analysis or average method. From a preliminary perspective, we also calculate the MCID using the distribution method.
Management information
Registered date
| 2022 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054970
