Spinal stimulation and arm orthosis among stroke patients

JRCT ID: jRCTs032210353

Registered date:29/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke
• Date of first enrollment: 29/09/2021
• Target sample size: 26
• Study type: Interventional
• Intervention(s): Transcutaneous spinal stimulation + arm orthosis group, ordinal exercise group

Outcome(s)

• Primary Outcome: Fugl-Meyer Assessment upper extremity score

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Fujiwara Toshiyuki
• Source(s) of Monetary Support: Pacific supply co.