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Randomized Controlled Trial on the Clinical Effectiveness of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Parkinson's Disease at Hoehn & Yahr Classification Stage III

Randomized Controlled Trial on the Clinical Effectiveness of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Parkinson's Disease at Hoehn & Yahr Classification Stage III - RCT of Somato-Cognitive Coordination Therapy using mediVR KAGURA in Parkinson's Disease at Hoehn & Yahr Classification Stage III

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056111
Enrollment
10
Registered
2024-11-09
Start date
2024-11-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

Patients who meet all of the following criteria who are randomly assigned to the group using the mediVR Kagura. 1) Patients who have been diagnosed with Parkinson&#39
s disease at Hoehn &amp
Yahr Classification Stage III 2) Patients who have not required medication adjustments for symptom fluctuations in the past month 3) Patients with a consciousness level of JCS 0-10 and amenable to f

Sponsors

National Hospital Organization Maizuru Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be considered. 1) Patients who have been diagnosed with Parkinson's disease at Hoehn & Yahr Classification Stage III 2) Patients who have not required medication adjustments for symptom fluctuations in the past month 3) Patients with a consciousness level of JCS 0-10 and amenable to follow-up 4) Patients who can be intervened in the training room in a wheelchair sitting position 5) 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.) 6) 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)-5) above.

Exclusion criteria

Exclusion criteria: Those deemed inappropriate for participation in the study by the principal investigator or research associate

Design outcomes

Primary

MeasureTime frame
The following indicators are measured and evaluated at the beginning of rehabilitation in the training room and 2 weeks after the start of 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.

Countries

Japan

Contacts

Public ContactYuta Oi

National Hospital Organization Maizuru Medical Center Neurosurgery

406-maizuru-mc@mail.hosp.go.jp0773622680

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026