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Completed

NCT Number: NCT03196739

Feasibility of Virtual Reality Games Using Head-mounted Display on Patients With Brain Disorders

Because virtual reality can provide more enriched environment, repetitive goal-oriented tasks, and increased patients' interest and motivation, it is expected to stimulate neuroplasticity of injured brain and promote recovery in patients with brain disorders. On the other hand, immersive virtual reality using a head-mounted display has not yet been attempted in the rehabilitation of patients with brain disorders. In addition to the benefits of existing virtual reality or game rehabilitation, immersive virtual reality can further enhance brain plasticity, such as the effect of mirror therapy or action observation, through self-awareness of the body in the virtual space. The purpose of this study is to investigate the feasibility of applying the immersive virtual reality using a head-mounted display in patients with upper extremity dysfunction due to brain disorders.

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Key information

Conditions

Upper Extremity Dysfunction Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea Workers' Compensation & Welfare Service Incheon Hospital, Incheon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with upper extremity dysfunction due to brain disorders (eg, stroke, traumatic brain injury, brain tumor, etc.)
  • Patient who can move the upper limb against the gravity (MRC grade 3 or above in both shoulder and elbow flexion)
  • Patient who can maintain stable sitting position
  • Adults over 18 years old
  • Patients who voluntarily agreed to participate in the study

Exclusion criteria

  • A moderate-to-severe cognitive impairment score of 18 or less in Mini-Mental Status Examination (MMSE)
  • Peripheral nerve injury, joint disease, other diseases of the upper extremity dysfunctions other than brain disorders
  • Patients with a history of severe dizziness or epilepsy
  • Patients with other medical illness that are difficult to participate in the study

Treatment and study plan

Virtual rehabilitation

Device

A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist.

Primary outcomes

  1. Change of Action Research Arm Test

    Time frame: at study completion, an average of 1 month

    19 items including grasp, grip, pinch, and gross arm movement

Secondary outcomes

  1. Change of Box and Block Test

    Time frame: at study completion, an average of 1 month

    the number of blocks carried over the partition from one compartment to the other during the one-minute trial period

  2. Change of Modified Barthel Index

    Time frame: at study completion, an average of 1 month

    Evaluation of activities of daily living

  3. Time of participation

    Time frame: at study completion, an average of 1 month

    Total time of patient's participation in the study intervention

  4. Patient's satisfaction

    Time frame: at study completion, an average of 1 month

    Evaluation of patient's satisfaction to the study intervention using a Likert scale

  5. Patient's discomfort

    Time frame: at study completion, an average of 1 month

    Evaluation of patient's discomfort to the study intervention using a Likert

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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