UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061268 |
|---|---|
| Receipt number | R000070105 |
| Scientific Title | Effects of Purposeful Activity-Based Electrical Stimulation Therapy on Brain Function in Patients with Severe Upper Limb Hemiparesis in Chronic Stroke: A Crossover Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/15 12:20:23 |
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Basic information
Public title
Effect of Purposeful Activity-Based Electrical Stimulation Therapy on Severe Upper Limb Paralysis in Chronic Stroke Patients
Acronym
PA-EST Crossover Trial
Scientific Title
Effects of Purposeful Activity-Based Electrical Stimulation Therapy on Brain Function in Patients with Severe Upper Limb Hemiparesis in Chronic Stroke: A Crossover Randomized Controlled Trial
Scientific Title:Acronym
PA-EST Crossover RCT
Region
| Japan |
Condition
Condition
Chronic stroke with severe upper limb hemiparesis
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effectiveness of purposeful activity-based electrical stimulation therapy (PA-EST) in patients with severe upper limb hemiparesis in chronic stroke, and to compare its effects on brain function and motor function with those of stretching therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cerebral hemodynamics (oxygenated hemoglobin concentration) measured by functional near-infrared spectroscopy (fNIRS), assessed before and after each intervention period
Key secondary outcomes
Upper limb motor function (Fugl-Meyer Assessment), amount and quality of use of the affected upper limb (Motor Activity Log),and goal attainment (Goal Attainment Scaling) will be assessed before and after each intervention period
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Purposeful activity-based electrical stimulation therapy (PA-EST)
PA-EST consists of functional electrical stimulation combined with purposeful upper limb activities tailored to the participants daily life goals in patients with severe upper limb hemiparesis after chronic stroke. The intervention period is 3 months. Home-based training is performed twice daily for 5-30 minutes per session, at least 3 times per week. In addition, therapist-guided training focusing on daily activities and instruction on the use of the affected upper limb in daily life are provided.
Interventions/Control_2
Stretching therapy
Stretching therapy consists of stretching exercises for the affected upper limb in patients with severe upper limb hemiparesis after chronic stroke. The intervention period is 3 months. Home-based training is performed twice daily for 5-30 minutes per session, at least 3 times per week. In addition, occupational therapy focusing on daily activities and instruction on the use of the affected upper limb in daily life are provided.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic stroke, defined as more than 1 year since onset
Severe upper limb hemiparesis with a Fugl-Meyer Assessment (FMA) upper extremity score of <33
Minimal voluntary movement of the affected upper limb
Living at home
Receiving occupational therapy
Able to communicate in daily conversation
No higher brain dysfunction that interferes with daily life
Key exclusion criteria
Presence of a cardiac pacemaker
Malignant lesions at the stimulation site
Fracture, dislocation, or other local disorders at the stimulation site
Severe cognitive impairment that interferes with daily communication
Higher brain dysfunction that interferes with daily life
Considered unsuitable for participation by the investigator or attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Minami |
Organization
Gunma Paz University
Division name
Department of Occupational Therapy, Faculty of Rehabilitation
Zip code
371-0823
Address
1-7-1 Tonya-machi, Maebashi, Gunma, Japan
TEL
0748635670
se-minami@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Minami |
Organization
Hyogo Medical University
Division name
Faculty of Rehabilitation Science
Zip code
650-8530
Address
1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783043060
Homepage URL
se-minami@hyo-med.ac.jp
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Tonya-machi, Maebashi, Gunma, Japan
Tel
027-365-3366
paz-kenkyu@paz.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | 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
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070105
