UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061584 |
|---|---|
| Receipt number | R000070455 |
| Scientific Title | Safety and Feasibility of Physiotherapy using Knee-Ankle-Foot Orthosis for Patients with Acute Stroke An Open-Label, Single-Center, Randomized controlled, Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/19 08:43:04 |
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Basic information
Public title
Safety and Feasibility of Physiotherapy using Knee-Ankle-Foot Orthosis for Patients with Acute Stroke
A-single center Randomized Controlled Study
Acronym
Knee-Ankle-Foot Orthosis therapy for Patients with Acute Stroke
A-single center Randomized Controlled Study
Scientific Title
Safety and Feasibility of Physiotherapy using Knee-Ankle-Foot Orthosis for Patients with Acute Stroke
An Open-Label, Single-Center, Randomized controlled, Parallel-Group Comparative Trial
Scientific Title:Acronym
RCT for evaluating the safety and feasibility of KAFO therapy for acute stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility of intensive standing/walking exercise using Knee-ankle-foot orthosis for patients with acute stroke
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Time spent standing or walking during physiotherapy
Initiating and maintaining Knee-ankle-foot orthosis use for 20 minutes or longer
Dropout rate
Interruption rate
Presence of adverse events during physiotherapy (hypotension, falls, fractures, pain, orthotic-related skin injuries, worsening musculoskeletal symptoms, worsening neurological symptoms, respiratory or circulatory abnormalities)
Adverse events during hospitalization (worsening neurological symptoms, recurrence, hydrocephalus, pneumonia, urinary tract infection, other infections, epileptic seizures, pressure ulcers, deep vein thrombosis, cardiovascular events (heart failure, myocardial infarction, etc.), hemorrhagic events (cerebral hemorrhage, gastrointestinal bleeding, etc.)) Presence or absence of major adverse cardiovascular events (MACE: recurrent stroke, myocardial infarction, heart failure)
Key secondary outcomes
Motricity Index
FAC
Trunk control Test
Berg balance Scale
FSS-ICU
Barthel Index
mRS
FIM-Motor
All outcomes are assessed in 14days from admission
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Intervention group
Standing and walking exercises while wearing a Knee-ankle-foot orthosis, to be started within 10 days of onset and performed for at least 20 minutes per day
Continue for up to 14 days of hospitalization; if discharged before then, the program ends on the date of discharge
Interventions/Control_2
Control group
Standard,usual physiotherapy
Standing and walking exercises while wearing a Knee-ankle-foot orthosis are permitted
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
Cerebral infarction or hemorrhage, excluding TIA and aSAH
Aged 18 years or older, but under 90 years
Hospitalization within 48 hours of symptom onset
mRS score of 0 to 2 prior to symptom onset
Condition stabilized within 9 days of onset, allowing for standing exercises
FAC0 to 1, less than BRS of lower limb5 at the time of enrollment
Regardless of whether thrombolytic therapy or thrombectomy was performed
Key exclusion criteria
Patients with obesity, BMI of 35 or higher
Patients unable to cooperate with exercises due to severe impaired consciousness or higher brain dysfunction
Patients with severe ataxia that significantly impairs exercise performance
Patients with musculoskeletal problems in the lower limbs or trunk that significantly impair exercise performance
Patients with a history of fragility fractures in the lower limbs or trunk
Patients with severe medical conditions that impair exercise performance
Palliative care has been selected
Unable to cooperate with exercises
Consent for study participation not obtained within 9 days of admission
Using assistive devices, robotics intended to stabilize the knee joint
Individuals deemed by the physical therapist to be capable of standing and walking exercises without a Knee-ankle-foot orthosis
Not eligible for Knee-ankle-foot orthosis wearing, due to weight, physique, skeletal structures
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kobayashi |
Organization
Sapporo medical university
Division name
School of medicine, Department of anatomy, Division of functional morphology
Zip code
0608556
Address
S-1 W-17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan
TEL
011-611-2111
ekobayashi0610@gmail.com
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Kobayashi |
Organization
Sapporo medical university
Division name
School of medicine, Department of anatomy, Division of functional morphology
Zip code
0608556
Address
S-1 W-17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan
TEL
011-611-2111
Homepage URL
ekobayashi0610@gmail.com
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Sapporo Medical University
Address
S-1 W-17, Chuo-ku, Sapporo, Hokkaido, 060-8556, Japan
Tel
011-611-2111
rinri@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070455
