Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

Not Applicable

Terminated

• Conditions: Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial
• Interventions: Other: immersion virtual reality (VR)-based rehabilitation; Other: traditional rehabilitation training

• Registration Number: NCT03086889
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

The investigators will conduct a single-blind, randomized controlled trial of 60 patients with subacute stroke. Patients will be randomly assigned into a control group and an intervention group. The intervention group will participate in immersion VR training for 3 weeks. The control group will receive for traditional rehabilitation training for 3 weeks. Then, the patients will be reevaluated to determine changes in upper extremity function, cognitive function, cortical and subcortical activation patterns, and performance of activities of daily living after the baseline assessment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Study Start: 2017-04-20
• Primary Completion: 2022-05-01
• Status Verified: 2023-01
• Study Completion: 2023-01-01
• Last Update Submitted: 2023-01-14
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. having had an ischemic stroke in the first time
2. age 30 to 80 years old
3. first stroke within 2 month
4. GCS score >8
5. the upper-limb function BrunnstromⅡ、Ⅲ

Exclusion Criteria

1. hemorrhage or transient ischemic attack(TIA)
2. important organs such as heart, lung, liver, kidney function decline or failure
3. previous history of brain neurosurgery or epilepsy
4. had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators
5. with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group	immersion virtual reality (VR)-based rehabilitation	The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks.
The control group	traditional rehabilitation training	The control group will receive for traditional rehabilitation training for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Arm Movement Ability at 3 months	Baseline and at 3 months	The Fugl-Meyer Assessment

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Activities of Daily Living (ADL) at 3 months	Baseline and at 3 months	The Barthel index
Change from Baseline Cognitive Function at 3 months	Baseline and at 3 months	the Korea-MiniMental Status Evaluation (K-MMSE)
Change from Baseline Cortical and Subcortical Activation Patterns at 3 months	Baseline and at 3 months	Functional MRI (fMRI)

Trial Locations

Locations (1)

Songhe Jiang; 🇨🇳 Wenzhou, Zhejiang, China