NCT03086889

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

5 years

First QC Date

March 9, 2017

Last Update Submit

January 14, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Arm Movement Ability at 3 months

    The Fugl-Meyer Assessment

    Baseline and at 3 months

Secondary Outcomes (3)

  • Change from Baseline Activities of Daily Living (ADL) at 3 months

    Baseline and at 3 months

  • Change from Baseline Cognitive Function at 3 months

    Baseline and at 3 months

  • Change from Baseline Cortical and Subcortical Activation Patterns at 3 months

    Baseline and at 3 months

Study Arms (2)

The intervention group

EXPERIMENTAL

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

Other: immersion virtual reality (VR)-based rehabilitation

The control group

OTHER

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

Other: traditional rehabilitation training

Interventions

immersion virtual reality (VR)-based rehabilitationOTHER

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 intervention group
traditional rehabilitation trainingOTHER

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.

The control group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songhe Jiang

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (2)

  • 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.

    PMID: 37947856DERIVED

  • 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.

    PMID: 30728055DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 22, 2017

Study Start

April 20, 2017

Primary Completion

May 1, 2022

Study Completion

January 1, 2023

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

CN(1)