Immersive Virtual Reality in Post Stroke

NCT04379687 | Unknown DMC

• 1 other identifier: VR stroke
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Balance; Stroke; Physical Therapy; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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

  45 minutes

• 10 meter walk test.

  Dynamic balance and gait

  15 minutes

• 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).

  15 minutes

• Balance Evaluation Systems Test (BESTtest)

  Static balance and functional mobility

  45 minutes

• Timed Get uo and go test

  Dynamic balance and gait

  10 minutes

Secondary Outcomes (3)

• Stroke-specific quality of life scale (ECVI-38)

  15 minutes

• The Barthel Index

  10 minutes

• Ad hoc questionnaire

  10 minutes

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Virtual reality OTHER

Use of virtual reality glasses for balance work

Virtual reality

Control group OTHER

Balance treatment with according to Bayouk physiotherapy

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yolanda Marcen Roman: lead
• Universidad de Zaragoza: collaborator

Study Sites (1)

Hospital universitario Miguel servet

Zaragoza, 50009, Spain

Location

Related Publications (8)

• 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.

  PMID: 24457190 BACKGROUND

• 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.

  PMID: 28137928 BACKGROUND

• 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.

  PMID: 28389108 BACKGROUND

• 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.

  PMID: 28421032 BACKGROUND

• 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.

  PMID: 28222783 BACKGROUND

• 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.

  PMID: 28701101 BACKGROUND

• 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.

  PMID: 25448245 BACKGROUND

• 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.

  PMID: 29156493 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aitor Garay Sanchez, Master

  IIS Aragón

  STUDY CHAIR

• Mercedes Ferrando Margeli, Master

  IIS Aragón

  PRINCIPAL INVESTIGATOR

• María Ángeles Franco Sierra, PhD

  IIS Aragón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigador

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: May 7, 2020
• Study Start: July 28, 2020
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)