UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062955 |
|---|---|
| Receipt number | R000072072 |
| Scientific Title | An observational study of the minimal important difference of the Gait Assessment and Intervention Tool in patients with chronic stroke |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/16 19:56:44 |
* 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
A study of meaningful change in Gait Assessment and Intervention Tool scores in patients with chronic stroke
Acronym
G.A.I.T.-MID study
Scientific Title
An observational study of the minimal important difference of the Gait Assessment and Intervention Tool in patients with chronic stroke
Scientific Title:Acronym
G.A.I.T.-MID study
Region
| Japan |
Condition
Condition
Chronic post-stroke hemiparesis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the minimal important difference (MID), defined as the smallest clinically meaningful change in G.A.I.T. scores, and examine its relationship with the smallest detectable change (SDC) in patients with chronic stroke.
Basic objectives2
Others
Basic objectives -Others
Assessment of the minimal important difference (MID), reliability, and smallest detectable change (SDC) of the G.A.I.T.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The MID in G.A.I.T. scores estimated using patient-reported GROC (Global Rating of Change) as the primary anchor.
Key secondary outcomes
A reference cutoff value for changes in G.A.I.T. scores derived from ROC analysis using patient-reported GROC; a supportive MID estimate using clinician-rated GROC as an anchor; distribution-based indices to aid interpretation of the MID; and the ICC, SEM, and SDC of the G.A.I.T. under test-retest and inter-rater conditions.
A supplementary analysis of changes in G.A.I.T. scores among participants meeting the improvement criteria for 10-m walking speed will be conducted to support MID estimation.
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
Patients with chronic stroke at least 6 months after stroke onset.
Patients with hemiparesis.
Patients aged 18 years or older.
Patients with Functional Ambulation Category (FAC) level 4 or 5, with or without walking aids or orthoses.
Patients able to safely perform the walking tasks required for G.A.I.T. assessment.
Key exclusion criteria
Patients who have difficulty understanding instructions or responding to the Global Rating of Change (GROC).
Patients who are medically unstable.
Patients with pain affecting gait.
Patients with orthopedic conditions affecting gait.
Patients considered unsuitable for participation by the principal investigator or treating physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
michiyukikawakami@keio.jp
Public contact
Name of contact person
| 1st name | Junsuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
junsuke.4drive@gmail.com
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective cohort study. Eligible patients receiving treatment for gait impairment at Keio University Hospital will be enrolled after providing written informed consent. Enrollment will run from September 17, 2026, through December 31, 2029.
G.A.I.T. will be assessed at three time points: before treatment, at retest, and after treatment. The post-treatment assessment will be performed within 7 weeks of the pre-treatment assessment. Lower-limb Fugl-Meyer Assessment (FMA) scores and 10-m walking speed will be assessed before and after treatment. Patient-reported and clinician-rated GROC will be assessed after treatment. The MID will be estimated, and the ICC, SEM, and SDC will be calculated under test-retest and inter-rater conditions.
Management information
Registered date
| 2026 | Year | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072072
