UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060820 |
|---|---|
| Receipt number | R000069596 |
| Scientific Title | Comparison of alternate gait training methods using knee-ankle-foot orthoses in stroke patients with hemiplegia: A pilot study |
| Date of disclosure of the study information | 2026/03/04 |
| Last modified on | 2026/03/04 17:59:09 |
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Basic information
Public title
A pilot study of gait training using KAFO in stroke patients: Comparison between patient-paced and therapist-led approaches
Acronym
AGT-Pilot
Scientific Title
Comparison of alternate gait training methods using knee-ankle-foot orthoses in stroke patients with hemiplegia: A pilot study
Scientific Title:Acronym
AGT-Pilot
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study is to clarify whether patient-paced alternate gait training (PP-AGT) or therapist-led alternate gait training (TL-AGT) is more effective in improving gait ability in stroke patients using knee-ankle-foot orthoses (KAFO). The results will be used to obtain information necessary for calculating the accurate sample size for a subsequent main study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Ambulation Category (FAC)
Key secondary outcomes
Functional Independence Measure (FIM) gait score at discharge
Timing of AGT (Alternate Gait Training) termination (Duration until weaning from KAFO)
Stroke Impairment Assessment Set (SIAS) lower limb motor scores (hip, knee, and ankle) at discharge
Knee extension strength on the non-paretic side at discharge
Fugl-Meyer Assessment (FMA) score at discharge
Total Functional Independence Measure (FIM) score at discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention 1: Patient-Paced Alternate Gait Training (PP-AGT)
Description: Walking training is performed using a knee-ankle-foot orthosis (KAFO) with a Gait Solution ankle joint and the knee joint locked in extension. The training involves an alternate gait pattern, stepping forward with each leg alternately.
Specific Conditions: The use of parallel bars or a cane is allowed. The walking pace is determined by the participant (patient-paced), and the physical therapist (PT) provides only the minimal assistance necessary to maintain the gait movement.
Protocol: At least 5 sessions per week, with a total duration of 10 minutes or more per session.
Interventions/Control_2
Intervention 2: Therapist-Led Alternate Gait Training (TL-AGT)
Description: Walking training is performed using a knee-ankle-foot orthosis (KAFO) with a Gait Solution ankle joint and the knee joint locked in extension. The training involves an alternate gait pattern, stepping forward with each leg alternately.
Specific Conditions: The use of assistive devices such as parallel bars or canes is prohibited. The physical therapist (PT) supports the participant from behind and actively guides and leads the rhythmic walking movements.
Protocol: At least 5 sessions per week, with a total duration of 10 minutes or more per
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
Stroke patients with hemiplegia
Patients requiring total assistance for walking at admission (Functional Independence Measure [FIM] gait score of 1)
Patients meeting the following criteria for requiring a knee-ankle-foot orthosis (KAFO):
Inability to walk appropriately with an ankle-foot orthosis (AFO) due to physical issues such as knee buckling or hyperextension (genu recurvatum)
Absence of joint range of motion (ROM) limitations in the lower limbs that would hinder alternate gait training (AGT)
Presence of moderate to severe motor paralysis, defined as a Stroke Impairment Assessment Set (SIAS) knee motor score of 3 or less
Patients whose participation is approved by the physical therapist in charge
Key exclusion criteria
Patients who are discharged within 3 months after the start of AGT
Patients with more than 3 months elapsed from stroke onset to the start of AGT
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Munehito |
| Middle name | |
| Last name | Kamakura |
Organization
Naka-Izu Rehabilitation Center
Division name
Department of Rehabilitation, Division of Physical Therapy
Zip code
410-2507
Address
1521-1 Hiekawa, Izu-shi, Shizuoka, Japan
TEL
0558-83-2111
mu.kamakura@gmail.com
Public contact
Name of contact person
| 1st name | Munehito |
| Middle name | |
| Last name | Kamakura |
Organization
Naka-Izu Rehabilitation Center
Division name
Department of Rehabilitation, Division of Physical Therapy
Zip code
410-2507
Address
1521-1 Hiekawa, Izu-shi, Shizuoka, Japan
TEL
0558-83-2111
Homepage URL
mu.kamakura@gmail.com
Sponsor or person
Institute
Naka-Izu Rehabilitation Center
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 Naka-Izu Rehabilitation Center
Address
1521-1 Hiekawa, Izu-shi, Shizuoka, Japan
Tel
0558-83-2111
webmail@janrc.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
| 2026 | Year | 03 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069596
