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Establishment of Virtual Reality System for Stroke Patients With Aphasia

T

Taipei Veterans General Hospital

Status

Enrolling

Conditions

Aphasia

Treatments

Other: traditional speech therapy
Other: virtual reality speech training

Study type

Interventional

Funder types

Other

Identifiers

NCT05606393
2021-01-012C

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

traditional speech therapy and additional virtual reality training group
Experimental group
Description:
Each participant received 1-hour traditional speech therapy(ST) and additional 30-minute VR training immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks.
Treatment:
Other: traditional speech therapy
Other: virtual reality speech training
traditional speech therapy group
Active Comparator group
Description:
Each participant received 1-hour traditional speech therapy(ST) only for each session. All participants received 3 sessions of treatment every week for 3 weeks.
Treatment:
Other: traditional speech therapy

Trial contacts and locations

1

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Central trial contact

Po-Yi Tsai, MD

Data sourced from clinicaltrials.gov

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