Effective examination of the belt electrode type skeletal muscle electric stimulation for severeness stroke patients

JRCT ID: jRCT1040210049

Registered date:06/08/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: stroke
• Date of first enrollment: 06/08/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

For study patients, the B-SES group conducts electrical stimulation to the trunk, lower limbs using B-SES outside rehabilitation time. The Control group undergoes rehabilitation as usual and decides not to practice more. We perform measurement of the non-paralysis side knee extension muscular strength using HHD the measurement of the muscle cross section of the paralysis side, fault paralysis side thigh / cruris using CT on the day before initiation and the end next day of each group.
About intervention by B-SES.
Posture: It is the position of the dorsal position belt in a bed.
As for the waist harness, the belt upper end is a navel.
As for the thigh harness, the belt bottom end is a patellar superior border.
Stimulation frequency: 20Hz.
Stimulation intensity: The maximum that we can endure.
A period: Six weeks.
Frequency: 20 minutes / day. 10th / two weeks.
An enforcement timing: Rehabilitation overtime.
Setting environment: After having become the dorsal position in a bed, it covers it with a partition from all around and exposes abdomen, a femoral region to light. We attach a belt to each site and hang a towel on the top. If we put up the output, and it reaches maximal intensity to endure, we perform electrical stimulation for 20 minutes.

Outcome(s)

Primary Outcome

A muscle cross section of the paralysis side by CT, non-paralysis side thigh/cruris.
The non-paralysis side knee extension muscular strength due to HHD.

Secondary Outcome

Age.Sex.Height.Weight.Body mass index (as follows: BMI).Disease.Coexistence symptom.Edical history.Stroke Impairment Assessment Set(as follows: SIAS).
Functional Independence Measure(as follows: FIM).
It is the basic information such as periods,and the like after the onset.
Walking ability. Cognitive function.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: The on admission walk FIM2 point severe stroke patients that FIM-C satisfies 19 points or more as follows.
• Exclude criteria: The person that a person and electrical stimulation become contraindicated with the stroke contralateral for a medical history

Related Information

• Primary Sponsor: sonoda sigeru