Immersive Virtual Reality Based Training for Rehabilitation of Subacute Stroke

NCT ID: NCT03086889

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2023-01-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The intervention group

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

Group Type EXPERIMENTAL

immersion virtual reality (VR)-based rehabilitation

Intervention Type OTHER

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.

The control group

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

Group Type OTHER

traditional rehabilitation training

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Song-he Jiang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Songhe Jiang

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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Huang Q, Jiang X, Jin Y, Wu B, Vigotsky AD, Fan L, Gu P, Tu W, Huang L, Jiang S. Immersive virtual reality-based rehabilitation for subacute stroke: a randomized controlled trial. J Neurol. 2024 Mar;271(3):1256-1266. doi: 10.1007/s00415-023-12060-y. Epub 2023 Nov 10.

Reference Type DERIVED
PMID: 37947856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30728055 (View on PubMed)

Other Identifiers

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KFYXK001

Identifier Type: -

Identifier Source: org_study_id

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