Clinical trial NCT05606393: Establishment of Virtual Reality System for Stroke Patients With Aphasia
Official title: Establishment of Virtual Reality System for Stroke Patients With Aphasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphasia
Keywords: virtual reality
aphasia
language rehabilitation
stroke
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aphasia can significantly influence a person's social relationship and quality of life. To achieve positive language outcomes, an intensive and high-repetition speech therapy is essential. However, due to the limited number of speech therapists, the intensity and frequency of training are often insufficient. Therefore, it is critical to develop other rehabilitation approaches to enhance the benefits of aphasia intervention. Virtual reality (VR) is an immersive and interactive computer simulation technology that can promote the ecological validity of speech therapy. In this study, we develop an innovative VR software for speech training to explore the effects of VR on various aspects of language outcomes.

Detailed description: We randomly assigned study participants into 2 groups: the traditional speech therapy (ST) group and the traditional ST with additional VR training (ST+VR) group. In the ST group, each participant received 1-hour traditional ST for each session. In the ST+VR group, an additional 30-minute VR training was administered immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks. For outcome measurement, we administered Concise Chinese Aphasia Test (CCAT) at 3 different time points: before treatment, 1 day and 3 months after the completion of treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke with aphasia, including fluent and non-fluent types
* Age between 20\~80-year-old
* Able to understand virtual reality training
* Able to cooperate with instructions and follow the rules
* Able to use the virtual reality controller and device
* Able to sign the subject's informed consent

Exclusion Criteria:

* Diagnosis of brain pathology other than stoke, such as brain tumor, Parkinson's disease, dementia
* Unable to cooperate with the instructions
* Unable to learn how to use the virtual reality controller and device
* Any medical diseases or unstable vital signs that may cause safety concern
* Severe hearing or vision impairments
* Have ever received any form of speech therapy or virtual reality training

Primary outcomes:
measure: Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment
timeFrame: Baseline and at 1 day after total treatments complete
measure: Changes of Concise Chinese Aphasia Test (CCAT) scores at 3 months after treatment
timeFrame: Baseline and at 3 months after total treatments complete
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: