UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056854 |
|---|---|
| Receipt number | R000064988 |
| Scientific Title | Comparative Observational Study of Different Complex Walking Tasks in Patients with Subacute Stroke |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2026/05/08 11:58:48 |
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Basic information
Public title
Comparative Observational Study of Different Complex Walking Tasks in Patients with Subacute Stroke
Acronym
Comparative Observational Study of Different Complex Walking Tasks in Patients with Subacute Stroke
Scientific Title
Comparative Observational Study of Different Complex Walking Tasks in Patients with Subacute Stroke
Scientific Title:Acronym
Comparative Observational Study of Different Complex Walking Tasks in Patients with Subacute Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing complex gait tasks with an additional visuospatial task and those incorporating a visuospatial task in subacute stroke patients, this study aims to explore patient characteristics that are more responsive to each task. Additionally, it seeks to determine which approach is more optimal for predicting fall risk during hospitalization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Dual Task Effect
Number of falls
Incidence of falls
Key secondary outcomes
Age
Sex
Years of Education
Body Mass Index
Past Medical history:diabetes, heart disease)
Types of Walking Aids
Presence or Absence of Aphasia
Lesion Location, Type, and Number of Brain Injuries
Days Since Onset
Fugl-Meyer Assessment
Mini-Balance Evaluation Systems Test
Stroke Impairment Assessment Set-Sensory Function
10-Meter Walk Test(Maximum Effort, Walking Speed, and Step Count)
3m Timed Up and Go test
Trail Making Test A & B
Catherine Bergego Scale
Mini-Mental State Examination
Functional Independence Measure
Falls Efficacy Scale-International
Acceleration and Angular Velocity During Walking
Visual Analog Scale
Temporal Experience Tracing
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
(1)Individuals with Functional Ambulation Category score of 4 or higher(use of a cane or lower-limb orthosis is permitted).
(2)Individuals capable of independently walking at least 90 meters continuously .
(3)Individuals engaged in dual-task walking or walking training with an additional or incorporated cognitive task
Key exclusion criteria
(1)Individuals with severe higher brain dysfunction, cognitive impairment, or visual impairment that prevents them from understanding or completing the experimental tasks.
(2)Individuals experiencing pain that interferes with walking.
(3)Individuals who cannot walk without using walking aids other than a cane or lower-limb orthosis (e.g., a walker or rollator).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Wada |
Organization
Aijinkai Rehabilitation Hospital
Division name
Rehabilitation Technology Division
Zip code
569-1116
Address
5-7, Hakubai-Cho, Takatsuki-Shi, Osaka
TEL
072-683-1212
wada.tatsuya.x1@aijinkai-group.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Wada |
Organization
Aijinkai Rehabilitation Hospital
Division name
Rehabilitation Technology Division
Zip code
569-1116
Address
5-7, Hakubai-Cho, Takatsuki-Shi, Osaka
TEL
072-683-1212
Homepage URL
wada.tatsuya.x1@aijinkai-group.com
Sponsor or person
Institute
Aijinkai Rehabilitation Hospital
Institute
Department
Personal name
Tatsuya Wada
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
Aijinkai Rehabilitation Hospital
Address
5-7, Hakubai-Cho, Takatsuki-Shi, Osaka
Tel
072-683-1212
wada.tatsuya.x1@aijinkai-group.com
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 | 03 | Month | 01 | 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
| 2025 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Study design
An internal-pilot, sequential Bayes-factor design will be employed. Feasibility (completion rate, data-capture success, adverse events) will be assessed after the first 5 participants; if no protocol amendment is required, the main study proceeds. The first Bayesian analysis will be carried out at n = 25. Data collection will stop when BF10 >= 10 (supporting the alternative) or BF10 <= 0.1 (supporting the null). When BF10 is between 0.1 and 10, additional cohorts of 20 participants will be enrolled until either boundary is reached or the cap of 100 participants is met.
(2) Target sample size and rationale
G*Power 3.1 (alpha = 0.05; power = 0.80; assumed fall rate = 20%) indicated that 25, 70, and 308 participants are required in logistic regression to detect odds ratios (OR) of 5.0, 2.5, and 1.5, respectively. The study therefore begins with 25 participants and sets an upper limit of 100 to provide sufficient power to detect a moderate effect (OR about 2.5) while minimizing unnecessary enrollment.
(3) Statistical analyses
(3-1) To identify patient characteristics associated with greater responsiveness to each walking task, Dual-Task Cost (DTC) will be modeled as the dependent variable in Bayesian hierarchical models and decision-tree analysis with secondary outcomes such as gait speed as predictors.
(3-2) In-hospital fall occurrence and count will be the dependent variables. Bayesian logistic or Poisson regression with DTC from each walking task as independent variables will evaluate their association with falls.
(4) Software
Analyses will be performed with R (v 4.3.1), JASP (v 0.19.3), and Python (Jupyter Notebook).
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064988
