Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03086889
• Other study ID #: KFYXK001
• Status: Terminated
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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 Brunnstrom???

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

Related Conditions & MeSH terms

• Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Songhe Jiang	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Arm Movement Ability at 3 months	The Fugl-Meyer Assessment	Baseline and at 3 months
Secondary	Change from Baseline Activities of Daily Living (ADL) at 3 months	The Barthel index	Baseline and at 3 months
Secondary	Change from Baseline Cognitive Function at 3 months	the Korea-MiniMental Status Evaluation (K-MMSE)	Baseline and at 3 months
Secondary	Change from Baseline Cortical and Subcortical Activation Patterns at 3 months	Functional MRI (fMRI)	Baseline and at 3 months