UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056619 |
|---|---|
| Receipt number | R000064711 |
| Scientific Title | Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/01/03 14:40:47 |
* 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
Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study
Acronym
Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study
Scientific Title
Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study
Scientific Title:Acronym
Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study
Region
| Japan |
Condition
Condition
In patients after stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to influence of gait training using KAFOs on gait ability and independent in patients with severe stroke hemiplegia and pusher behavior following USN.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale for Contraversive Pushing (SCP), BITc (BIT-conventional test), Subjective Postural Vertical (SPV), SPV with eyes opened (SPV-EO) direction errors, variability errors, functional ambulation category; FAC and gait independence (FIM-gait).
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria comprised first-ever stroke cases, Brunnstrom Recovery Stage-Lower Limb (BRS-L) under III, indicating severe hemiplegia.
Key exclusion criteria
Exclusion criteria included BRS over IV, dementia, multiple cerebral infarctions, hydrocephalus, and poor understanding.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
2798567
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
08012079205
k-sawa@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
2798567
Address
5-8-1 Akemi, Urayasu, Chiba, Japan
TEL
08012079205
Homepage URL
k-sawa@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Kota Sawa
Funding Source
Organization
SBC Tokyo Medical University
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
SBC Tokyo Medical University
Address
5-8-1, Akemi, Urayasu, Chiba, Japan, 279-8567
Tel
08012079205
k-sawa@sbctmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
No. 000049806
Org. issuing International ID_1
The University Hospital Medical Information Network Center
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 | 06 | Day |
Related information
URL releasing protocol
https://doi.org/10.1002/brb3.3001
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1002/brb3.3001
Number of participants that the trial has enrolled
44
Results
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05). Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior.
Results date posted
| 2025 | Year | 01 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participant pool included 44 patients, comprising 22 hemiplegics and 22 patients with pusher behavior. Demographic data were matched using a propensity score (PS) to adjust for heterogeneity in background factors (baseline covariates) at a new study-patient ratio of 1:1.
Participant flow
Procedure A
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05, Table 2, Figure 3).
Procedure B
Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior. The study items included age, sex, onset days, BRS-L, MMSE, damaged hemispheric side, SIAS, SCP, BITc, SPV, SPV-EO directional errors, and variability errors. Onset days and SPV variability errors were identified as influencing factors in severe hemiplegia cases, and SPV-EO variability errors in pusher cases, each with moderate regression coefficients (p<0.05) (Table 3).
Adverse events
None.
Outcome measures
For outcomes in procedure A: two-way analysis of variance was utilized to confirm interactions and simple main effects, using the Bonferroni method as a post-hoc test (p<0.05). For outcomes in procedure B: multiple regression analysis (stepwise method) was applied to examine gait independence within the two groups.28 Factor analysis variables were analyzed using group gait ability (FAC and FIM) as the dependent variable and characteristic factors as the independent variables (p<0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Procedure A: The long-term prognosis was evaluated in two groups of patients: those with severe motor paralysis and those with severe motor paralysis along with pusher behavior.
Procedure B: Factors influencing gait ability in pusher cases were investigated. The timing of KAFOs use in both groups was defined as within 1 week of the rehabilitation prescription date in sub-acute-phase hospital. Furthermore, considering the severity of motor paralysis, patients utilized KAFOs for over 3 months during rehabilitation and ADLs.
Regarding the utilization of KAFOs in the course of routine rehabilitation, patients received physical therapy, occupational therapy, and speech therapy for 3 h, 7 days a week, over consecutive weeks. During specific interventions, KAFOs were employed for 1 h during standing and gait exercises (Figure 2). In ADLs scenarios, transfers and toileting were permitted with AFOs. Patients were allowed to use AFOs for transferring and toileting in ADLs situations and to continue gait rehabilitation using KAFOs or AFOs throughout the intervention period.
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064711
