UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056655 |
|---|---|
| Receipt number | R000064754 |
| Scientific Title | Effects of Different Amounts of Functional Electrical Stimulation on Gait Post Stroke |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2025/01/07 22:00:18 |
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Basic information
Public title
Effects of Different Amounts of Functional Electrical Stimulation on Gait Post Stroke
Acronym
Effects of Different Amounts of Functional Electrical Stimulation on Gait Post Stroke
Scientific Title
Effects of Different Amounts of Functional Electrical Stimulation on Gait Post Stroke
Scientific Title:Acronym
Effects of Different Amounts of Functional Electrical Stimulation on Gait Post Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the 2021 Stroke Treatment Guidelines, the use of Functional Electrical Stimulation (FES) to improve gait function in stroke patients with foot drop is deemed appropriate and is rated with a recommendation level of B and high evidence level. However, most previous studies on FES have focused on chronic-phase stroke patients and typically involved usage of approximately 30 minutes per session. The effects of longer usage durations, such as over 60 minutes, have not been sufficiently investigated.
On the other hand, HANDS therapy, an FES intervention aimed at improving upper limb function in stroke patients, incorporates considerations of task specificity and dose-dependent effects. It recommends extended FES usage for the upper limb, with patients undergoing 8 hours per day for 3 weeks during daily life, demonstrating functional recovery and elucidating the underlying recovery mechanisms.
In this study, the "usage amount" of FES is defined as the number of stimulations delivered during FES usage. Drawing inspiration from HANDS therapy, this study applies extended-duration FES to the lower limb. It is hypothesized that prolonged FES usage will increase the number of stimulations compared to short-duration usage, and the study aims to evaluate the effects of increased stimulation counts beyond those achieved with conventional short-duration usage.
This study seeks to clarify the impact of differences in FES usage amounts on gait ability and aims to provide insights that contribute to the improvement of activities of daily living and quality of life in subacute stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait Speed (The Day Before Intervention, Two Weeks After Intervention Start, Four Weeks After Intervention Start)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For two weeks, only standard rehabilitation will be performed
Interventions/Control_2
For 8 hours during the day, including standard rehabilitation time, an FES device will be attached to the affected lower leg. Electrical stimulation will be applied to the peroneal nerve area in synchronization with the swing phase of the affected side during gait.
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 hospitalized in a recovery-phase rehabilitation ward. First-onset stroke with mild to moderate motor paralysis characterized by equinovarus deformity of the affected lower limb, score of 17-30 on the lower limb section of the Fugl-Meyer Assessment, maximum score 34. Gait ability allowing for independent or supervised indoor walking, score of 3-5 on the Functional Ambulation Categories. No contraindications to electrical stimulation. A Mini-Mental State Examination score of 23 or higher indicating sufficient understanding of the study's purpose.
Key exclusion criteria
The principal investigator will inquire about any history of orthopedic or neurological conditions affecting motor function, as well as any history of respiratory or cardiovascular diseases. Individuals with severe deformities, signs such as dizziness, or contraindications to electrical stimulation therapy will be excluded from the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Konno |
Organization
Shonan Keiiku Hospital
Division name
Department of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa-shi, Kanagawa, Japan
TEL
0466-48-0050
skh.sk@outlook.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Konno |
Organization
Shonan Keiiku Hospital
Division name
Department of Rehabilitation
Zip code
252-0816
Address
4360 Endo, Fujisawa-shi, Kanagawa, Japan
TEL
0466-48-0050
Homepage URL
skh.sk@outlook.jp
Sponsor or person
Institute
Shonan Keiiku Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Keiiku Hospital
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
Shonan Keiiku Hospital
Address
4360 Endo, Fujisawa-shi, Kanagawa, Japan
Tel
0466-48-0050
skh.sk@outlook.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
湘南慶育病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 07 | 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
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064754
