Immersive Virtual Reality in Post Stroke

NCT ID: NCT04379687

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-28
• Study Completion Date: 2023-12-30

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.

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.

Conditions

Balance; Stroke; Physical Therapy; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

Use of virtual reality glasses for balance work

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

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Balance treatment with according to Bayouk physiotherapy

Interventions

Virtual reality

Use of virtual reality glasses for balance work

Intervention Type: OTHER

Control group

Balance treatment with according to Bayouk physiotherapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Yolanda Marcen Roman

OTHER

Sponsor Role: lead

Responsible Party

Yolanda Marcen Roman

Principal investigador

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aitor Garay Sanchez, Master

Role: STUDY_CHAIR

IIS Aragón

Mercedes Ferrando Margeli, Master

Role: PRINCIPAL_INVESTIGATOR

IIS Aragón

María Ángeles Franco Sierra, PhD

Role: PRINCIPAL_INVESTIGATOR

IIS Aragón

Locations

Hospital universitario Miguel servet

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 24457190 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28137928 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28389108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28421032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28222783 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28701101 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25448245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29156493 (View on PubMed)

Other Identifiers

VR stroke

Identifier Type: -

Identifier Source: org_study_id