Immersive Virtual Reality in Post Stroke

September 26, 2023 updated by: Yolanda Marcen Roman

Immersive Virtual Reality in Post Stroke Physiotherapy

Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the most widely used conventional physiotherapy intervention programs in the hospital setting.

Advances in technology have made it possible to start using immersive VR in the therapeutic approach to various pathologies that affect motor function.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the physiotherapy intervention programs specifically most used in the hospital setting.

Main aims

1-To determine if the designed immersive VR training program is better in the short term (15 sessions) and in the medium term (30 sessions) than the conventional physiotherapy training with respect to the change of the parameters related to the static balance in sitting and standing and dynamic balance in post-stroke patients.

Secondary aims 2. To determine the efficacy in the short term (15 sessions) and in the medium term (30 sessions) of immersive VR systems compared to conventional physiotherapy procedures regarding the quality of life associated with stroke, the degree of independence and autonomy .

3. To determine the safety of the application of training programs in immersive VR settings in post-stroke subjects with respect to the number of adverse effects produced.

4. Determine prognostic factors associated with insufficient improvement (less than moderate change) after stroke treatment with the designed immersive VR program and with conventional physiotherapy treatment.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults> 18 years and <80 years.
  • Diagnosis of hemiparesis or post-stroke hemiplegia.
  • Minimum score of 2 points on item 3.2 of the Berg Scale, which establishes that the patient can remain in a sitting position for 30s without help.

Exclusion Criteria:

  • Aphasia, scores over 45 on the Mississippi Aphasia Screening Test.
  • Cerebellar pathology.
  • Hemineglect or previous neurological disorder.
  • Visual disturbances that prevent the use of VR glasses.
  • Moderate cognitive decline, scores less than 43 on the Mini-mental State examination.
  • Previous musculoskeletal disorders that make it difficult or impossible to balance sitting and standing or walking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
  1. st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control. 15 minutes
  2. nd part: Experimental training program for static and dynamic balance in sitting and standing by immersive Virtual Reality. 15 minutes
Other: Virtual reality
Use of virtual reality glasses for balance work
Active Comparator: Control group
  1. st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control.15 minutes
  2. nd part: Training program for static and dynamic balance in sitting and standing, according to Bayouk. 15 minutes
Other: Control group
Balance treatment with according to Bayouk physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Assessment Scale for Stroke Patients (PASS).
Time Frame: 45 minutes

Static balance and functional mobility, This consists of 12 items and is subdivided into two parts: mobility (7 items) and balance (5 items), each with a score ranging from 0 (minimum) to 3 (maximum); the total scale score is 36 points.

The PASS is made up of 12 items of increasing difficulty, of a 4-point scale in which items are scored from 0 to 3. The total score varies from 0 to 36
45 minutes
10 meter walk test.
Time Frame: 15 minutes
Dynamic balance and gait
15 minutes
Berg Balance Scale
Time Frame: 15 minutes
Static balance and functional mobility The Berg scale comprises 14 items (score comprised 0-4). Total scores can range from 0 (severely impaired balance) to 56 (excellent balance).
15 minutes
Balance Evaluation Systems Test (BESTtest)
Time Frame: 45 minutes
Static balance and functional mobility
45 minutes
Timed Get uo and go test
Time Frame: 10 minutes
Dynamic balance and gait
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke-specific quality of life scale (ECVI-38)
Time Frame: 15 minutes
Quality of life associated with stroke It has comprises 38 items, (score comprised 1-5). Total scores can range from 38 (excellent) to 190 point (very poor quality of life)
15 minutes
The Barthel Index
Time Frame: 10 minutes
Degree of autonomy The sum of the scores obtained will determine the degree of dependency, so if the person is less than 20, they are considered totally dependent, if they are between 40 and 55, they are moderately dependent, if they are over 60, they are considered to be dependent mild and if it is 100 it will be totally independent (95 in case you need the use of a wheelchair
10 minutes
Ad hoc questionnaire
Time Frame: 10 minutes
Adverse effects
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yolanda Marcen Roman

Collaborators

Universidad de Zaragoza

Investigators

  • Study Chair: Aitor Garay Sanchez, Master, IIS Aragón
  • Principal Investigator: Mercedes Ferrando Margeli, Master, IIS Aragón
  • Principal Investigator: María Ángeles Franco Sierra, PhD, IIS Aragón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2020

Primary Completion (Actual)

April 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

April 17, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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