Clinical trial NCT05148052: Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.
Official title: Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Virtual reality
Upper Extremity Paresis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: National Traffic Injury Rehabilitation Hospital
name: Korea Workers' Compensation and Welfare Service Incheon Hospital
First posted: 2021-12-08
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

Detailed description: This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Fifteen chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

\*Due to recruitment challenges, the anticipated enrollment has been revised from 36 to 15.

Eligibility criteria: Inclusion Criteria:

* Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke
* Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)
* Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively
* Patients who can stably maintain a sitting position
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)
* Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.
* Patients with a history of severe vertigo or epilepsy
* Patients with medical reasons such as medical conditions that make it difficult to participate in research
* Patients who may be pregnant or who are pregnant or lactating

Primary outcomes:
measure: Action Research Arm Test
timeFrame: Within 2 days after the end of each intervention
Secondary outcomes:
measure: Box and Block test
timeFrame: Within 2 days after the end of each intervention
measure: Fugl-Meyer (FM) Assessment
timeFrame: Within 2 days after the end of each intervention
measure: Modified Barthel Index
timeFrame: Within 2 days after the end of each intervention
measure: Grip strength
timeFrame: Within 2 days after the end of each intervention
measure: Beck Depression Inventory (BDI)
timeFrame: Within 2 days after the end of each intervention
measure: Simulator Sickness Questionnaire
timeFrame: Day 1 and Day 12 of virtual reality exergames intervention
Other outcomes:
Locations:
city: Yangpyeong
country: Korea, Republic of
facility: National Traffic Injury Rehabilitation Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Han Gil Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: