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Spinal stimulation and arm orthosis among stroke patients

Spinal stimulation and arm orthosis for upper extremity motor function among patients with hemiparesis. Radomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210353
Enrollment
26
Registered
2021-09-29
Start date
2021-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke Cerebrovascular disease

Interventions

Transcutaneous spinal stimulation + arm orthosis group, ordinal exercise group

Sponsors

Fujiwara Toshiyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Hemiparesis patients based on first onset stroke. 2. Age 20 years and more and <80years. 3. 60 days and more from onset of stroke. 4. SIAS finger function test is 3 or less and knee-mouth test is 2 or more. 5. Surface sense of upper extremity is scored 1 or more with SIAS 6. ROM of wrist is enough to wear the devise (XMM-HR2) 7. Spasticity of paretic finger is 2 or less with modified Ashworth Scale 8. 2 month and more from the last boturinum therapy, if patient received the boturinum therapy. 9. Patients who could come to outpatient clinic following to the study protocol.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac disease 2. Uncontrolled hypertension 3. Acute illness and fever 4. Recent medical history of pulmonary embolism, acute cor pulmonale, and severe pulmonary hypertension 5. Severe liver failure and renal failure 6. Orthopedic complication, preventing exercise 7. Severe cognitive impairment and mental illness 8. Other metabolic disease 9. contraindication of electrical stimulation 10. Pace-maker user

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment upper extremity score

Secondary

MeasureTime frame
Box and Block (BBT) Motor activity Log-14 (amount of use)(MAL-14 AOU) Modified Ashworth scale (finger , wrist, elbow) SIAS finger function test Reciprocal Inhibition in paretic upper extremity Motor Evoked Potential (MEP) by transcranial magnetic stimulation

Contacts

Public ContactToshiyuki Fujiwara

Juntendo University Hospital

t-fujiwara@juntendo.ac.jp+81-338133111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026