UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058039 |
|---|---|
| Receipt number | R000066335 |
| Scientific Title | Verification of the Effects of L300Go Functional Electrical Stimulation Device on Gait Function in Children with Cerebral Palsy |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/06/01 16:59:01 |
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Basic information
Public title
A Study on the Effectiveness of the L300Go Walking Support Device in Children with Cerebral Palsy
Acronym
L300Go Gait Support Study for Children with Cerebral Palsy
Scientific Title
Verification of the Effects of L300Go Functional Electrical Stimulation Device on Gait Function in Children with Cerebral Palsy
Scientific Title:Acronym
Interventional study (Treatment)
Region
| Japan |
Condition
Condition
Cerebral Palsy
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the L300Go functional electrical stimulation device in improving gait function in children with cerebral palsy (GMFCS Level I-II).
Basic objectives2
Others
Basic objectives -Others
To assess the usability and satisfaction of the L300Go device among pediatric patients and their caregivers, and to explore changes in muscle activity and actual usage conditions during home-based training.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in gait function before and after using the L300Go (walking speed, step length, gait symmetry)
Key secondary outcomes
Muscle activity (surface electromyography)
User and caregiver satisfaction with device use
Usage status during home use (e.g., wearing time)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Functional gait training using the L300Go functional electrical stimulation device will be provided to children with cerebral palsy (ages 6-12) in both hospital and home settings. Gait function will be assessed before and after the intervention, including walking speed, step length, and gait symmetry.
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children aged 6-12 years diagnosed with cerebral palsy
Classified as GMFCS Level I or II
Without visual or intellectual impairment
Receiving gait training with the L300Go at Tobu Ryoiku Center
Able to provide informed consent and assent
Key exclusion criteria
Difficulty walking due to recent fractures, etc.
High frequency of epileptic seizures that may interfere with gait training
Risk of skin complications from using the L300Go
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Institute of Science Tokyo
Division name
Department of Rehabilitation Medicine
Zip code
112
Address
1-5-45, Bunkyo-ku, Tokyo
TEL
0358035648
t_sakai.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Institute of Science Tokyo
Division name
Department of Rehabilitation Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358035648
Homepage URL
t_sakai.orth@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Tomoko Sakai
Funding Source
Organization
others
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
Ethics Committee, Tokyo University of Science
Address
1-5-45, Yushima,
Tel
0358035648
rinri.adm@tmd.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
| 2025 | Year | 06 | Month | 15 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | 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
Management information
Registered date
| 2025 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066335
