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

JRCT ID: jRCTs052180056

Registered date:12/02/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stroke, Traumatic brain injury, spinal cord injury, peripheral nerve injury
• Date of first enrollment: 12/11/2017
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The intervention group attaches a wearable integrated volitional control electrical stimulation device for 6 hours a day, 28 days. The target muscle is extensor digitorum muscle. The patient actively uses paralyzed upper extremity in daily life. Therapy are performed physical therapy, occupational therapy and speech-language-hearing therapy, total 180 minutes a day at most. The control group attaches a conventional integrated volitional control electrical stimulation device for 6 hours a day, 28 days. The target muscle is extensor digitorum muscle. The patient actively uses paralyzed upper extremity in daily life. Therapy are performed physical therapy, occupational therapy and speech-language-hearing therapy, total 180 minutes a day at most.

Outcome(s)

• Primary Outcome: Fugl-Meyer assessment score for upper extremity

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include 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.
• Exclude 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)

Related Information

• Primary Sponsor: Mikami Yasuo
• Source(s) of Monetary Support: SK-Electronics CO.,LTD.
• Secondary ID(s): UMIN000026624