Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Songhe Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks.	Other: immersion virtual reality (VR)-based rehabilitation; Intervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance.
Other: The control group; The control group will receive for traditional rehabilitation training for 3 weeks.	Other: traditional rehabilitation training; The traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Arm Movement Ability at 3 months	The Fugl-Meyer Assessment	Baseline and at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General Publications

• Huang Q, Wu W, Chen X, Wu B, Wu L, Huang X, Jiang S, Huang L. Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial. Trials. 2019 Feb 6;20(1):104. doi: 10.1186/s13063-019-3177-y.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: KFYXK001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No