Pilot study: Virtual Reality with a mobile HMD-VR-system for neurorehabilitation: patients in neurological rehabilitatio

Phase 2

• Conditions: I63; I61; I60; S06.5; S06.4; S06; D33; D43; C71; G01

• Registration Number: DRKS00023605
• Lead Sponsor: iving Brain GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-31
• Study Start: 2022-09-23
• Results First Posted: 2023-07-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• legally competent male and female patients aged 18 years and older,
• who are in inpatient neurological rehabilitation treatment due to acute damage to or disease of the brain (e.g. cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, subdural or epidural intracranial hemorrhage, traumatic brain injury, brain tumor, meningitis or encephalitis, hypoxic encephalitis),
• and have agreed to participate in the study.
• Full functionality for one arm
• Sufficient vision (or corrected) in the central field of vision, no double vision
• No previous psychiatric illness in the patient's medical history

Exclusion Criteria

• Psychiatric comorbidities: Acute: depression, schizophrenia, suicidality, dementia
• Dementia and the MMST score below 24 points
• Known overreaction to visual stimulation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- change of cognitive performance (measured by TL-D, AKT, TMT A&B, FEPVR, LPS3, WMS-R),<br>- change of morbidity concerning acute neurological diseases in rehabilitation in contrast to trial start (EQ-5D VAS)

Secondary Outcome Measures

Name	Time	Method
- change of affect (PANAS),<br>- self-reported Quality of Life (SF36),<br>- change of performance in a realistic setting, relevant for AdL, in contrast to status at trial start (FEPVR)