Randomized Comparative Trial of Upper Limb Motor Function Recovery and Improvement in Movement-Induced Brain Waves through Accelerated Upper Limb Movement Image Observation Training

UMIN ID: UMIN000054226

Registered date:04/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Stroke hemiplegia
• Date of first enrollment: 2024/04/25
• Target sample size: 48
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A video of the upper limb reaching forward is shown to patients with severe paralysis of stroke (FMA-UE score less than 20, MMSE score less than 24, and KVIQ score less than 75) in addition to the normal rehabilitation time, and give them an image of exercise. In the video, one set of 60 reach movements is performed, and seven sets of these movements are performed in one training session, aiming for a total of 420 trials. This training is performed three times a week for four weeks, and the training is completed after a total of 5,040 attempts. Practice with the video playback speed set to 1.0x.
Show the video of reaching forward with the upper limb to stroke patients with severe paralysis (FMA-UE score less than 20, MMSE score less than 24, and KVIQ score less than 75) during regular rehabilitation sessions. In addition to the usual rehabilitation time, engage them in mental imagery of the movement. The video depicts one set of 60 repetitions of reaching movements. Aim to complete 7 sets in one training session, totaling 420 repetitions. Repeat this training three times a week for four weeks, reaching a total of 5040 repetitions. Practice at the playback speed that the patient subjectively evaluates as the most conducive for mental imagery, choosing from speeds of 1.5x, 2.0x, 3.0x, and 4.0x.

Outcome(s)

• Primary Outcome: Fugl-Meyer Assessment UpperExtremity
• Secondary Outcome: 1) ERD Power 2) Kinesthetic and Visual Imagery Questionnaire: KVIQ-20 (sensory scales) 3) AOMI practice time until reaching 5040 trials 4) Optimal speed from 1x to 4.0x speed on the Visual Analog Scale: VAS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: 1) Those unable to perform motor imagery or tasks. 2) Individuals with a history of or current mental illness. 3) Those with central nervous system disorders other than stroke or orthopedic disorders significantly limiting recovery from paralysis.

Related Information

• Primary Sponsor: Saitama Prefectural University
• Source(s) of Monetary Support: Non
• Secondary ID(s): R5-5