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Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immersion virtual reality (VR)-based rehabilitation
traditional rehabilitation training
Sponsored by
Second Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Songhe Jiang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The intervention group

The control group

Arm Description

The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks.

The control group will receive for traditional rehabilitation training for 3 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline Arm Movement Ability at 3 months
The Fugl-Meyer Assessment

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2017
Last Updated
January 14, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03086889
Brief Title
Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke
Official Title
Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke：Study Protocol of a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
The trials were stopped after recruiting 60% of the planned sample after a median of 3 months follow-up and one interim analysis. The immersive virtual reality based training has proven to work.
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention group
Arm Type
Experimental
Arm Description
The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks.
Arm Title
The control group
Arm Type
Other
Arm Description
The control group will receive for traditional rehabilitation training for 3 weeks.
Intervention Type
Other
Intervention Name(s)
immersion virtual reality (VR)-based rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional rehabilitation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Arm Movement Ability at 3 months
Description
The Fugl-Meyer Assessment
Time Frame
Baseline and at 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline Activities of Daily Living (ADL) at 3 months
Description
The Barthel index
Time Frame
Baseline and at 3 months
Title
Change from Baseline Cognitive Function at 3 months
Description
the Korea-MiniMental Status Evaluation (K-MMSE)
Time Frame
Baseline and at 3 months
Title
Change from Baseline Cortical and Subcortical Activation Patterns at 3 months
Description
Functional MRI (fMRI)
Time Frame
Baseline and at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: having had an ischemic stroke in the first time age 30 to 80 years old first stroke within 2 month GCS score >8 the upper-limb function BrunnstromⅡ、Ⅲ Exclusion Criteria: hemorrhage or transient ischemic attack(TIA) important organs such as heart, lung, liver, kidney function decline or failure previous history of brain neurosurgery or epilepsy had severe cognitive impairments or aphasia, which made the participants unable to understand the instructions given by the investigators with claustrophobia and body with metal (such as metal teeth, etc.) are not suitable for to MRI scanning
Facility Information:
Facility Name
Songhe Jiang
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30728055
Citation
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.
Results Reference
derived

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Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

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