Stroke
Conditions
Interventions
Active-assistive training using the hand robot consists of a sequence of movements comprising mass flexion, relaxation, mass extension, and relaxation. One set consists of 30 repetitions (10 repetitio
s physical condition and safety considerations. During the second training session, the ROM established during the first session is maintained without modification in order to ensure consistency and r
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible participants were chronic stroke survivors who met the following criteria: (1) at least 6 months had elapsed since stroke onset; (2) finger motor function was impaired, defined as both mass flexion and mass extension on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), Section C, being less than fully completed; (3) age between 18 and 80 years; and (4) ability to understand the study procedures and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Difficulty understanding or performing the training due to cognitive impairment or aphasia. 2. Severe contractures with a risk of injury during wrist movement. 3. Severe wrist flexor hypertonia preventing passive movement (Modified Ashworth Scale score of 4). 4. Skin disorders at electrode attachment sites or hand unit contact areas. 5. Musculoskeletal diseases (e.g., osteoporosis or rheumatologic disorders) affecting bones or muscles. 6. Inability to elicit motor evoked potentials (MEPs). 7. Presence of metallic implants near the stimulation site (e.g., cochlear implants, intracranial clips, deep brain or vagus nerve stimulators), or implanted medical devices such as pacemakers, implantable cardioverter-defibrillators, neurostimulators, or drug infusion pumps. 8. Pregnancy or suspected pregnancy. 9. Untreated epilepsy or poorly controlled epilepsy despite medication (e.g., seizures within the past year). 10. Initiation or dose change of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) within the past four weeks. 11. Current use of tricyclic antidepressants. 12. Severe headache defined as a Migraine Disability Assessment (MIDAS) grade III or higher. 13. History of migraine with 1 or more attacks per month in the past 12 months, or migraine with aura, when the investigator judges a high risk of attack induction. 14. Severe cardiac disease, including unstable angina, recent myocardial infarction, decompensated heart failure, acute cor pulmonale, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis or endocarditis, or NYHA class III or higher heart failure. Additionally, individuals judged by the investigators to be unsuitable due to poor general medical condition will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TMS-induced motor evoked potentials (MEPs) measured pre-intervention, immediately post-intervention, 15 min post-intervention, and 30 min post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Ashworth Scale (MAS) and Box and Block Test (BBT) assessed before the robotic intervention and 30 min after the intervention; transcranial magnetic stimulation (TMS) measures, including short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF), assessed before the intervention, immediately after the intervention, 15 min after the intervention, and 30 min after the intervention. Surface electromyography (sEMG) data collected during the robotic training and before and after the intervention will be analyzed as exploratory outcomes. | — |
Countries
Japan
Contacts
Public ContactRAY SUZUE
Keio Univeraity Department of Rehabilitation Medicine
Outcome results
None listed