Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062833) titled 'Verification of the efficacy of an MR rehabilitation system for unilateral spatial neglect treatment' on Sept. 7.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Waseda University
Condition:
Condition - Unilateral spatial neglect
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluating the effects of three-dimensional locomotor visual search training using mixed reality on patients with unilateral spatial neglect
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Patients wear a head-mounted display (HMD) on their head and wearable sensors on their chest or waist. Multiple holograms are superimposed onto the physical environment. While visually searching the rehabilitation area, patients move via wheelchair or ambulation, approach the detected holograms, and acquire them through actions such as touching them by hand. This intervention is conducted for approximately 20 minutes per day.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Unilateral spatial neglect patient
2. Person who can perform a line erasure in the front midline without the assistance of a third party
3. Person who is not hemianopsia
4. Person in the hyperacute stage or later, more than 2 weeks after the onset of illness
5. Hemiplegic stroke patients in a rehabilitation hospital
Key exclusion criteria - 1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic embolism or pulmonary embolism
6. Acute infection
7. Thrombophlebitis
8. Ventricular tachycardia or refractory ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
10. Uncontrolled arterial or pulmonary hypertension
11. Those who are not capable of performing the tasks indicated in the test procedure (including breaks between tasks)
12. Those with obvious hemianopsia
Exclusion criteria are determined by the attending physician
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 14 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071928
Disclaimer: Curated by HT Syndication.