A Prospective Randomized Controlled Study of the Clinical Efficacy of Somato-Cognitive Coordination Therapy with mediVR Kagura

UMIN ID: UMIN000055665

Registered date:29/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage
• Date of first enrollment: 2024/07/08
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients who meet all of the following criteria who are randomly assigned to the group using the mediVR Kagura. 1) Patients admitted to the Stroke Care Unit (SCU) 2) Patients with a consciousness level of JCS 0-10 and amenable to follow-up 3) Patients who can be intervened in the training room in a wheelchair sitting position 4) Patients with physical dysfunction (ataxia, gait and balance problems, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.) 5) Patients who have obtained written consent for participation in the study from the patient or a surrogate (relative up to the fifth degree of kinship) within 10 days of the start of the intervention in the training room after fulfilling 1)-4) above.
Patients who meet all of the following criteria who are randomly assigned to the group that does not use the mediVR Kagura. 1) Patients admitted to the Stroke Care Unit (SCU) 2) Patients with a consciousness level of JCS 0-10 and amenable to follow-up 3) Patients who can be intervened in the training room in a wheelchair sitting position 4) Patients with physical dysfunction (ataxia, gait and balance problems, upper limb dysfunction, dysarthria, dysphagia, etc.) or cognitive dysfunction (higher brain dysfunction, attention disorder, hemispatial neglect, etc.) 5) Patients who have obtained written consent for participation in the study from the patient or a surrogate (relative up to the fifth degree of kinship) within 10 days of the start of the intervention in the training room after fulfilling 1)-4) above.

Outcome(s)

• Primary Outcome: The following indicators are measured and evaluated at the beginning of rehabilitation in the training room, 2 weeks, 4 weeks, and 6 weeks after the start of rehabilitation; if the patient is discharged before 6 weeks, the evaluation is terminated at the point of discharge; at the point of evaluation after 6 weeks, mediVR Kagura-guided rehabilitation in patients who were using mediVR Kagura ends, and thereafter continued normal rehabilitation. Common assessment measures: Functional Independence Measure (FIM), Stroke impairment Assessment Set (SIAS), 10-meter walk test, Timed up and go test (TUG), Brunnstrom Stages (BRST ), Fugl-Meyer Assessment (FMA), Motor Activity Log (MAL), Box and Block Test (BBT), Mini-Mental State Examination (MMSE), Frontal Assessment Battery ( FAB), and Trail Making Test (TMT). Patients with ataxia: Scale for the Assessment and Rating of Ataxia (SARA). Patients with attention disorders: line and star blotting. Patients with dysarthria: Assessment of Motor Speech for Dysarthria (AMSD), Oral diadochokinesis: Scale for Contraversive pushing (SCP). Other measures deemed necessary by the investigator.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Those deemed inappropriate for participation in the study by the principal investigator or research associate

Related Information

• Primary Sponsor: National Hospital Organization Maizuru Medical Center
• Source(s) of Monetary Support: None