Clinical application of a WIVES device for patient with motor disability in upper extremity at subacute phase

Phase 3

Recruiting

• Conditions: Stroke, Traumatic brain injury, spinal cord injury, peripheral nerve injury

• Registration Number: JPRN-jRCTs052180056
• Lead Sponsor: Mikami Yasuo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion criteria is as following: 1) the patient with motor disability in upper extremity, 2)Those who passed within 180 days since onset, 3) It is possible to detect the electromyogram of finger extension using the integrated volitional control electrical stimulation device.

Exclusion Criteria

Exclusion criteria is as following: 1) severe limited range of motion in wrist (wrist dorsiflexion<0 degree), 2) severe sensory disturbance (loss of superficial or deep sense), 3) severe higher brain dysfunction (Mini-mental state examination 23 points or less), 4) patient who already treated with combination therapy such as transcranial magnetic stimulation, Botulinum toxin therapy, constraint induced movement therapy, or rehabilitation robot, 5) patients with the contraindication of electrical stimulation therapy (Cardiovascular disease, Inserting a metal into the body like a pace maker, Infection, malignant tumor, use of metal implants for upper extremity, Abnormal blood pressure, Parts of abnormal skin, acute disease, Blood flow disturbance, pregnant woman)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment score for upper extremity

Secondary Outcome Measures

Name	Time	Method
1) Motor Activity Log (MAL)<br>2) Wolf Motor Function Test (WMFT)<br>3) Active range of motion (active ROM)<br>4) Action Research Arm Test (ARAT)<br>5) Modified Ashworth Scale (MAS)<br>6) Stroke Impairment Assessment Set (SIAS)<br>7) Brunnstrom stage test (Br.stage)<br>8) Functional Independence Measure (FIM)<br>9) Time to mount the devices<br>10) Feeling of use and fit of the devices