FES trial for knee OA

JRCT ID: jRCTs062180071

Registered date:19/03/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Knee Osteoarthritis
• Date of first enrollment: 12/06/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Vastus medialis reeducation by Functional Electrical Stimulator on walking exercise done on once to three times weekly for 6 months followed.

Outcome(s)

• Primary Outcome: Severity of knee osteoarthritis: Kellgren-Lawrence grade
• Secondary Outcome: Knee varus thrust, vastus medialis on set time, pain scale, knee function, knee abduct moment, body mass index

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1. Kellgren-Lawrence grade 1-3
2. out patient
3. written informed consent
4. without dementia

Exclude criteria

1. have disease on the other joints
2. cannot walk 10m
3. risk of fall (a score of 10 or above)
4. deemed inappropriate for this study by doctor
5. using cardiac pacemakers and other implantable medical electrical devices and metal implants
6. history or suspected epilepsy

Related Information

• Primary Sponsor: Ushio Kai
• Secondary Sponsor: Shimada Noboru
• Source(s) of Monetary Support: Japan society for the promotion of sience