UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060154 |
|---|---|
| Receipt number | R000068752 |
| Scientific Title | A study on the effects of functional electrical stimulation (FES) on gait rehabilitation after lumbar spine surgery |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/22 08:09:26 |
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Basic information
Public title
A study on the effects of functional electrical stimulation (FES) on gait rehabilitation after lumbar spine surgery
Acronym
The Effect of Functional Electrical Stimulation on Postoperative Foot Drop in Patients Following Lumbar Spine Surgery
Scientific Title
A study on the effects of functional electrical stimulation (FES) on gait rehabilitation after lumbar spine surgery
Scientific Title:Acronym
The Effect of Functional Electrical Stimulation on Postoperative Foot Drop in Patients Following Lumbar Spine Surgery
Region
| Japan |
Condition
Condition
Patients following lumbar spine surgery
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of gait training combined with functional electrical stimulation after surgery for degenerative lumbar spine disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle dorsiflexor muscle strength
Key secondary outcomes
10-Meter Walk Test
Oswestry Disability Index (ODI)
Functional Independence Measure(FIM)
Standing and gait analysis using electromyography and force plate systems
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The baseline phase (A) will last for two weeks, followed by a two-week intervention phase (B).
During the intervention phase, functional electrical stimulation will be applied in combined with gait training.
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
Patients scheduled to undergo surgery for degenerative lumbar spine disease
Able to ambulate
Ankle dorsiflexor muscle strength less than MMT grade 3
Key exclusion criteria
Individuals with contraindications to electrical stimulation therapy, such as those with implanted pacemakers
Individuals with other neurological or neuromuscular disorders, such as stroke
Individuals with other musculoskeletal disorders
Individuals with a history of prior spine surgery
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | RINTARO |
| Middle name | |
| Last name | YAIRO |
Organization
Gakkentoshi Hospital
Division name
Physical Medicine and Rehabilitation
Zip code
619-0238
Address
7-4-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
TEL
0774-98-2123
R.816taro@outlook.jp
Public contact
Name of contact person
| 1st name | RINTARO |
| Middle name | |
| Last name | YAIRO |
Organization
Gakkentoshi Hospital
Division name
Physical Medicine and Rehabilitation
Zip code
619-0238
Address
7-4-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
TEL
0774-98-2123
Homepage URL
R.816taro@outlook.jp
Sponsor or person
Institute
Gakkentoshi Hospital
Institute
Department
Personal name
RINTARO YAIRO
Funding Source
Organization
Japanese Society for Electrophysical Agents in Physical Therapy
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
Institutional Review Board of Gakkentoshi Hospital
Address
Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0238, Japan
Tel
0774-98-2123
fukata@iseikai.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
学研都市病院（京都府） Gakkentoshi Hospital（Kyoto）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068752
