A randomized controlled trial of the effect of electrical muscle stimulation (EMS) therapy on improving walking function in elderly people who can walk independently

JRCT ID: jRCT1032240312

Registered date:02/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Flaility, Extnding healthy life
• Date of first enrollment: 02/09/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Participants will be divided into two groups: an EMS user group and a non-EMS user group.
The EMS user group will receive exercise instruction and will use EMS on the lower legs at home once a day every day. Exercise instruction will involve locomotion training. EMS use must be for more than three months.
The non-EMS user group will receive only locomotion training instruction, the same as the EMS user group.

Outcome(s)

• Primary Outcome: Optimal walking speed
• Secondary Outcome: Whether or not a fall occurred, body composition measurement, vascular pulse wave test, blood test, gait evaluation using smart shoes, Berg Balance Scale, status of EMS and exercise therapy

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Elderly people aged 65 years or older at the time of enrollment. There is no upper age limit.
2) People who can walk 10m or more independently without using walking aids.
3) ADL at the time of enrollment is 85 points or higher on the Barthel Index. Measurements are performed by the researcher at the time of enrollment.
4) People who have sufficient consent to be involved in the study.

Exclude criteria

1) Those with venous thrombosis
2) Those with a history of joint replacement surgery
3) Those with implanted medical devices
4) Those with missing limbs
5) Those with an unstable illness
6) Those with heart disease undergoing treatment and unable to obtain permission from their primary care physician
7) Those already using some form of EMS equipment
8) Those who plan to begin regular exercise-related rehabilitation within the observation facility, such as day rehabilitation or home rehabilitation. Those already undergoing some form of regular rehabilitation will be allowed to continue and will not be excluded.
9) Others who are deemed unsuitable as subjects by a doctor

Related Information

• Primary Sponsor: Nishii Mototsugu
• Secondary Sponsor: MTG CO.,LTD,MTG CO.,LTD