UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050867 |
|---|---|
| Receipt number | R000057971 |
| Scientific Title | Evaluation of the Effectiveness of Low-Frequency Percutaneous Electrical Stimulation in Combination with Exercise Therapy for Spasticity in Patients with Living Cervical Spinal Cord Injury - A Single-Case Design -. |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2023/04/17 14:20:28 |
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Basic information
Public title
Evaluation of the Effectiveness of Low-Frequency Percutaneous Electrical Stimulation in Combination with Exercise Therapy for Spasticity in Patients with Living Cervical Spinal Cord Injury - A Single-Case Design -.
Acronym
Evaluation of the Effectiveness of Low-Frequency Percutaneous Electrical Stimulation in Combination with Exercise Therapy for Spasticity in Patients with Living Cervical Spinal Cord Injury - A Single-Case Design -.
Scientific Title
Evaluation of the Effectiveness of Low-Frequency Percutaneous Electrical Stimulation in Combination with Exercise Therapy for Spasticity in Patients with Living Cervical Spinal Cord Injury - A Single-Case Design -.
Scientific Title:Acronym
Evaluation of the Effectiveness of Low-Frequency Percutaneous Electrical Stimulation in Combination with Exercise Therapy for Spasticity in Patients with Living Cervical Spinal Cord Injury - A Single-Case Design -.
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the efficacy of low-frequency TENS combined with exercise therapy for spasticity in patients with living cervical cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite Spasticity Index
Key secondary outcomes
30 seconds automatic dorsiflexion of ankle joint
Ankle dorsiflexion range of motion
Comfortable 10m walking speed, number of steps
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Exercise Therapy Intervention
Interventions/Control_2
TENS combined intervention
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 with cervical spinal cord injury in the living stage who use outpatient rehabilitation
Patients with moderate spasticity on the Composite Spasticity Index of the plantar flexors of the ankle joint.
Patients who can walk independently.
Patients who are independent in activities of daily living
Patients who have given consent for this study
Key exclusion criteria
Patients with acute neurological symptoms
Patients with radiographic evidence of inflammatory disease, tumors, etc.
Patients with medical conditions that contraindicate exercise
Patients with neuromuscular diseases or skin diseases of the lower limbs
Persons with a cardiac pacemaker
Patients with cognitive impairment.
Those who require the assistance of another person for gait function assessment.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Nakano |
| Middle name | |
| Last name | Takuya |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Non
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
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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
| 2023 | Year | 04 | Month | 17 | 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
1
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
