Immersive Virtual Reality in Post Stroke

Stroke Clinical Trial

Official title:

Immersive Virtual Reality in Post Stroke Physiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379687
• Other study ID #: VR stroke
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 28, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Balance
• Physical Therapy
• Stroke
• Virtual Reality

Intervention

Other:
• Virtual reality
Use of virtual reality glasses for balance work
• Control group
Balance treatment with according to Bayouk physiotherapy

Locations

Country	Name	City	State
Spain	Hospital universitario Miguel servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Yolanda Marcen Roman	Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	10 meter walk test.	Dynamic balance and gait	15 minutes
Primary	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
Primary	Balance Evaluation Systems Test (BESTtest)	Static balance and functional mobility	45 minutes
Primary	Timed Get uo and go test	Dynamic balance and gait	10 minutes
Secondary	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)	15 minutes
Secondary	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	10 minutes
Secondary	Ad hoc questionnaire	Adverse effects	10 minutes