UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054013 |
|---|---|
| Receipt number | R000061637 |
| Scientific Title | The effect of acupuncture treatment on post-stroke spasticity: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2024/03/29 |
| Last modified on | 2024/03/29 21:06:32 |
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Basic information
Public title
Effect of acupuncture treatment on post-stroke spasticity. The world's first randomized double-blind controlled clinical trial.
Acronym
The effect of acupuncture on post-stroke spasticity.
Scientific Title
The effect of acupuncture treatment on post-stroke spasticity: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
The effect of acupuncture treatment on post-stroke spasticity: a randomized, double-blind, placebo-controlled trial
Region
| Japan |
Condition
Condition
Patients with post-stroke hemiplegia in the chronic phase.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of acupuncture on post-stroke spasticity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Muscle activity in spastic muscles (soleus) by superficial electromyography (sEMG)
2) Change of movement of the lower limbs in life (Visual Analogue Scale :VAS)
Key secondary outcomes
1) Modified ashworth scale
2) Fugl-Meyer assessment
3) Stroke-specific quality of life scale
4) Ease of taking a step on VAS
5) Practitioner's and patient's guess at the needle authenticity and their confidence in their guess on a VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Treatment with penetrating needles
Interventions/Control_2
Treatment with no-touch placebo needles (no stimulation with the needle tip that does not reach the skin)
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic stroke hemiplegia (between 6 months and 4 years after onset)
2) Patients who have sensory impairment and can walk out with or without the use of a walking aid.
Key exclusion criteria
1) Acute stroke patients (within 6 months after onset) or chronic stroke patients more than 4 years post-onset.
2) Diseases that are contraindications to rehabilitation, such as cardiac disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nobuari |
| Middle name | |
| Last name | Takakura |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Department of Acupuncture and Moxibustion
Zip code
135-0063
Address
Japan 2-9-1 Ariake Koto-ku, Tokyo
TEL
+08-3-6703-7000
Takakura@tau.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Ueno |
Organization
Y`s,Inc.
Division name
Corporate services department
Zip code
107-0052
Address
Japan Akasaka Intercity 10th floor, 1-11-44 Akasaka, Minato-ku, Tokyo
TEL
03-5542-0785
Homepage URL
research@ys-j.co.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Y`s,Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Health Sciences IRB
Address
135-0063 Japan 2-9-1 Ariake Koto-ku, Tokyo
Tel
+08-3-6703-7000
akiyama@tau.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
東京有明医療大学（東京都）/ Tokyo Ariake University of Medical and Health Sciences (Tokyo)
脳梗塞リハビリセンター（用賀、東京都) / Cerebral Infarction Rehabilitation Center (Yoga, Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 29 | 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
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 09 | 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
Although we obtained ethics approval in July 2021, the recruitment of participants was postponed because of COVID 19. In May 2023, COVID 19 was changed from category 2 to category 5 infectious diseases, and we started recruitment of participants.
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061637
| 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 |
