Clinical trial NCT04379687: Immersive Virtual Reality in Post Stroke
Official title: Immersive Virtual Reality in Post Stroke Physiotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Balance
Stroke
Physical Therapy
Virtual Reality
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
First posted: 2020-05-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postural Assessment Scale for Stroke Patients (PASS).
timeFrame: 45 minutes
measure: 10 meter walk test.
timeFrame: 15 minutes
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Balance Evaluation Systems Test (BESTtest)
timeFrame: 45 minutes
measure: Timed Get uo and go test
timeFrame: 10 minutes
Secondary outcomes:
measure: Stroke-specific quality of life scale (ECVI-38)
timeFrame: 15 minutes
measure: The Barthel Index
timeFrame: 10 minutes
measure: Ad hoc questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital universitario Miguel servet
Study officials:
affiliation: IIS Aragón
name: Aitor Garay Sanchez, Master
role: STUDY_CHAIR
affiliation: IIS Aragón
name: Mercedes Ferrando Margeli, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: IIS Aragón
name: María Ángeles Franco Sierra, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.