UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030080 |
|---|---|
| Receipt number | R000034343 |
| Scientific Title | Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy |
| Date of disclosure of the study information | 2017/11/22 |
| Last modified on | 2022/03/22 14:38:02 |
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Basic information
Public title
Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Acronym
Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title
Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Scientific Title:Acronym
Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify the effects of concurrent peripheral nerve stimulation (PNS) therapy on the forearm of the paralyzed side of the body, upper limb function, and improved movement in daily living of the stroke patients with upper limb paralysis underdoing repetitive transcranial magnetic stimulation (r-TMS) therapy and 2-week intensive occupation therapy (OT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wolf motor function test
Key secondary outcomes
Fugl-Meyer Assessment
Motor Activity Log
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Apply one hour per day of PNS therapy to the forearm of the paralyzed side of the body during OT to stroke patients with upper limb paralysis who are undergoing r-TMS therapy and 2-week intensive OT.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Aged 20 years or older at the time consent was obtained.
Ability to voluntarily extend at least three fingers, including the thumb.
Ability to raise the arm on the affected side to the level of the nipple or higher.
Six months or more have passed since the onset of stroke.
PNS therapy has been prescribed by the patient's physician.
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria
Severe aphasia, agnosia, apraxia, or other severe higher brain dysfunction that interferes with the procedures of the study.
Cutaneous anesthesia.
Having an inflammatory disease with arthritic inflammation, such as rheumatoid arthritis.
Previous participation in this study.
Previous history of receiving concurrent PNS therapy with r-TMS therapy.
Patients who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Independent Ethics Committee
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
鹿教湯病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
https://journals.sagepub.com/doi/full/10.1177/1569186120901633
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/1569186120901633
Number of participants that the trial has enrolled
11
Results
The Wolf Motor Function Test, Fugl-Meyer Assessment, and Motor Activity Log showed significant improvement after intervention in the peripheral nerve stimulation group. In particular, hand scores on the Fugl-Meyer Assessment improved significantly in the peripheral nerve stimulation group compared to controls (median change: 2 vs. 0; p = 0.021, r = 0.49).
Results date posted
| 2020 | Year | 12 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were chronic stroke patients who participated in a two-week inpatient programme including repetitive transcranial magnetic stimulation and occupational therapy.
Participant flow
the peripheral nerve stimulation group (11 patients who underwent peripheral nerve stimulation)
Adverse events
Nothing
Outcome measures
Wolf motor function test, Fugl-Meyer Assessment, Motor Activity Log
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034343
