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BalanceNCT04379687

Immersive Virtual Reality in Post Stroke

A study testing Virtual reality in people with Balance and Stroke, run by Yolanda Marcen Roman at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Balance, Stroke, Physical Therapy
What is being tested?
Virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteSpain
Study dates
28 Jul 2020to 30 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital universitario Miguel servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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.

Read the 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 .

  1. 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.
  2. 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.
Being tested
Virtual reality, Control group
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual realityOther

    Use of virtual reality glasses for balance work

  • Control groupOther

    Balance treatment with according to Bayouk physiotherapy

Study groups in NCT04379687
Study groupRoleWhat they receive
Virtual realityExperimental1. 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
Receives: Other: Virtual reality
Control groupActive comparator1. 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
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural Assessment Scale for Stroke Patients (PASS).

    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

    Measured: 45 minutes

  2. 10 meter walk test.

    Dynamic balance and gait

    Measured: 15 minutes

  3. Berg Balance Scale

    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).

    Measured: 15 minutes

  4. Balance Evaluation Systems Test (BESTtest)

    Static balance and functional mobility

    Measured: 45 minutes

  5. Timed Get uo and go test

    Dynamic balance and gait

    Measured: 10 minutes

Secondary outcomes (3)

  1. Stroke-specific quality of life scale (ECVI-38)

    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)

    Measured: 15 minutes

  2. The Barthel Index

    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

    Measured: 10 minutes

  3. Ad hoc questionnaire

    Adverse effects

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start28 Jul 2020
  3. Primary completion30 Apr 2023
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04379687
Sponsor's protocol ID
VR stroke
Status last verified
Sep 2023
First submitted
17 Apr 2020
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grefkes C, Fink GR. Connectivity-based approaches in stroke and recovery of function. Lancet Neurol. 2014 Feb;13(2):206-16. doi: 10.1016/S1474-4422(13)70264-3.

    PubMed 24457190

  • Hugues A, Di Marco J, Janiaud P, Xue Y, Pires J, Khademi H, Cucherat M, Bonan I, Gueyffier F, Rode G. Efficiency of physical therapy on postural imbalance after stroke: study protocol for a systematic review and meta-analysis. BMJ Open. 2017 Jan 30;7(1):e013348. doi: 10.1136/bmjopen-2016-013348.

    PubMed 28137928

  • Freburger JK, Li D, Johnson AM, Fraher EP. Physical and Occupational Therapy From the Acute to Community Setting After Stroke: Predictors of Use, Continuity of Care, and Timeliness of Care. Arch Phys Med Rehabil. 2018 Jun;99(6):1077-1089.e7. doi: 10.1016/j.apmr.2017.03.007. Epub 2017 Apr 4.

    PubMed 28389108

  • Li S. Spasticity, Motor Recovery, and Neural Plasticity after Stroke. Front Neurol. 2017 Apr 3;8:120. doi: 10.3389/fneur.2017.00120. eCollection 2017.

    PubMed 28421032

  • Kim A, Darakjian N, Finley JM. Walking in fully immersive virtual environments: an evaluation of potential adverse effects in older adults and individuals with Parkinson's disease. J Neuroeng Rehabil. 2017 Feb 21;14(1):16. doi: 10.1186/s12984-017-0225-2.

    PubMed 28222783

  • Yasuda K, Muroi D, Ohira M, Iwata H. Validation of an immersive virtual reality system for training near and far space neglect in individuals with stroke: a pilot study. Top Stroke Rehabil. 2017 Oct;24(7):533-538. doi: 10.1080/10749357.2017.1351069. Epub 2017 Jul 12.

    PubMed 28701101

  • Llorens R, Noe E, Colomer C, Alcaniz M. Effectiveness, usability, and cost-benefit of a virtual reality-based telerehabilitation program for balance recovery after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2015 Mar;96(3):418-425.e2. doi: 10.1016/j.apmr.2014.10.019. Epub 2014 Nov 13.

    PubMed 25448245

  • Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

    PubMed 29156493

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Balance and Stroke, run by Yolanda Marcen Roman at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Assessment Scale for Stroke Patients (PASS). (time frame: 45 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04379687, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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