UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056551 |
|---|---|
| Receipt number | R000064616 |
| Scientific Title | Effects of Single-Leg Robotic-Assisted Gait Training on Functional Recovery in Patients with Severe Hemiparetic Stroke |
| Date of disclosure of the study information | 2025/01/04 |
| Last modified on | 2026/05/09 18:15:03 |
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Basic information
Public title
Effects of Single-Leg Robotic-Assisted Gait Training on Functional Recovery in Patients with Severe Hemiparetic Stroke
Acronym
Effects of Single-Leg Robotic-Assisted Gait Training on Functional Recovery in Patients with Severe Hemiparetic Stroke
Scientific Title
Effects of Single-Leg Robotic-Assisted Gait Training on Functional Recovery in Patients with Severe Hemiparetic Stroke
Scientific Title:Acronym
Effects of Single-Leg Robotic-Assisted Gait Training on Functional Recovery in Patients with Severe Hemiparetic Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify the characteristics of patients with severe hemiparetic stroke who achieve gait improvement through single-leg robotic-assisted gait training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Gait Ability Assessment for hemiplegics(GAA)
Key secondary outcomes
Walking improvement efficiency
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
primary supratentorial intracerebral hemorrhage or cerebral infarction
Hemiplegia due to a first stroke
SIAS lower extremity total score <=5
GAA score <=4
Key exclusion criteria
History of subarachnoid hemorrhage
History of neuromuscular disease
Patients who declined to participate in the study
patients who were unable to undergo post-intervention assessments due to poor health or transfer to another hospital
Patients with less than 10 sessions of robotic gait training
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Asano |
Organization
Okayama Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
703-8265
Address
503-1 Kurata, Naka-ku, Okayama City, Okayama Prefecture
TEL
086-274-7001
t-asano@okayama-reha-hp.or.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Asano |
Organization
Okayama Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
703-8265
Address
503-1 Kurata, Naka-ku, Okayama City, Okayama Prefecture
TEL
086-274-7001
Homepage URL
t-asano@okayama-reha-hp.or.jp
Sponsor or person
Institute
Okayama Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Rehabilitation Hospital
Address
503-1 Kurata, Naka-ku, Okayama City, Okayama Prefecture
Tel
086-274-7001
t-asano@okayama-reha-hp.or.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 | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s12984-026-01961-4#citeas
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s12984-026-01961-4#citeas
Number of participants that the trial has enrolled
126
Results
A total of 126 participants were included. SIAS scores (knee extension, ankle dorsiflexion, joint position sense, trunk verticality, and abdominal strength), FIM scores (problem solving and memory), time from onset to RAGT initiation, and initial walking independence were associated with achieving walking with supervision. Among these factors, days to RAGT initiation (OR = 0.19), SIAS trunk verticality (OR = 7.79), and SIAS joint position sense (OR = 3.37) were independently associated with the outcome.
Results date posted
| 2026 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 28 | Day |
Baseline Characteristics
The mean age of the participants was 61.2 years (standard deviation = 11.8), and 29.4% (n = 37) were female. Ischemic stroke accounted for 37.3% (n = 47) of cases, and 42.9% (n = 54) had left-sided hemiplegia. The median time from stroke onset to RAGT initiation and the baseline GAA score was 42.5 days (interquartile range [IQR]: 34.0-54.8) and 3.0 points [IQR: 2.0-3.0], respectively.
Participant flow
A total of 250 participants were initially screened for eligibility between February 2018 and September 2024. Participants were excluded based on the following criteria: non-supratentorial lesions (n = 11), recurrent stroke (n = 15), SIAS score for lower-limb motor function > 5 (n = 59), and GAA score > 4 (n = 5). Individuals with subarachnoid hemorrhage (n = 7), presenting with concomitant neurological disease (n = 10), who declined participation in the study (n = 4), unable to perform post-intervention assessments due to ill health or hospital transfer (n = 4), or those who completed < 10 RAGT sessions (n = 9) were also excluded. Ultimately, 126 participants were included in the final analysis. All data were complete, with no missing values.
Adverse events
No adverse events resulting from the intervention occurred in this retrospective study
Outcome measures
Logistic regression identified three variables significantly associated with achieving walking with supervision (Fig. 4). Higher trunk verticality (OR = 7.79; 95% CI: 2.80-21.68, p = 0.0001) and preserved joint position sense (OR = 3.37; 95% CI: 1.23-9.24, p = 0.0183) were associated with an increased likelihood of success, whereas a longer time to RAGT initiation was associated with a decreased likelihood (OR = 0.19; 95% CI: 0.06-0.66, p = 0.0088).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 07 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 28 | Day |
Other
Other related information
Research design: Single-center retrospective cohort study
Recruitment method: Patients who used Welwalk (WW-1000 and WW-2000) at Okayama Rehabilitation Hospital from February 2018 to September 2024
Information to be measured and obtained: Gait Ability Assessment for hemiplegics (GAA), Stroke Impairment Assessment Set (SIAS), Functional Independence Measure (FIM), sex, age, disease name, disease classification, number of days from onset to start of robot exercises, number of units of rehabilitation performed.
Management information
Registered date
| 2024 | Year | 12 | Month | 24 | Day |
Last modified on
| 2026 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064616
