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Immersive Virtual Reality in Post Stroke

Primary Purpose

Balance, Stroke, Physical Therapy

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality
Control group
Sponsored by
Yolanda Marcen Roman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Balance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital universitario Miguel servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality

Control group

Arm Description

st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control. 15 minutes nd part: Experimental training program for static and dynamic balance in sitting and standing by immersive Virtual Reality. 15 minutes

st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control.15 minutes nd part: Training program for static and dynamic balance in sitting and standing, according to Bayouk. 15 minutes

Outcomes

Primary Outcome Measures

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
10 meter walk test.
Dynamic balance and gait
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).
Balance Evaluation Systems Test (BESTtest)
Static balance and functional mobility
Timed Get uo and go test
Dynamic balance and gait

Secondary Outcome Measures

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)
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
Ad hoc questionnaire
Adverse effects

Full Information

First Posted
April 17, 2020
Last Updated
September 26, 2023
Sponsor
Yolanda Marcen Roman
Collaborators
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04379687
Brief Title
Immersive Virtual Reality in Post Stroke
Official Title
Immersive Virtual Reality in Post Stroke Physiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yolanda Marcen Roman
Collaborators
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance, Stroke, Physical Therapy, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control. 15 minutes nd part: Experimental training program for static and dynamic balance in sitting and standing by immersive Virtual Reality. 15 minutes
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
st part: Conventional physiotherapy treatment program aimed at achieving functional improvement and increased postural control.15 minutes nd part: Training program for static and dynamic balance in sitting and standing, according to Bayouk. 15 minutes
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Use of virtual reality glasses for balance work
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Balance treatment with according to Bayouk physiotherapy
Primary Outcome Measure Information:
Title
Postural Assessment Scale for Stroke Patients (PASS).
Description
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
Time Frame
45 minutes
Title
10 meter walk test.
Description
Dynamic balance and gait
Time Frame
15 minutes
Title
Berg Balance Scale
Description
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).
Time Frame
15 minutes
Title
Balance Evaluation Systems Test (BESTtest)
Description
Static balance and functional mobility
Time Frame
45 minutes
Title
Timed Get uo and go test
Description
Dynamic balance and gait
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Stroke-specific quality of life scale (ECVI-38)
Description
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)
Time Frame
15 minutes
Title
The Barthel Index
Description
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
Time Frame
10 minutes
Title
Ad hoc questionnaire
Description
Adverse effects
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aitor Garay Sanchez, Master
Organizational Affiliation
IIS Aragón
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mercedes Ferrando Margeli, Master
Organizational Affiliation
IIS Aragón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Ángeles Franco Sierra, PhD
Organizational Affiliation
IIS Aragón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital universitario Miguel servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24457190
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.
Results Reference
background
PubMed Identifier
28137928
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.
Results Reference
background
PubMed Identifier
28389108
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.
Results Reference
background
PubMed Identifier
28421032
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.
Results Reference
background
PubMed Identifier
28222783
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.
Results Reference
background
PubMed Identifier
28701101
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.
Results Reference
background
PubMed Identifier
25448245
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.
Results Reference
background
PubMed Identifier
29156493
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.
Results Reference
background

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Immersive Virtual Reality in Post Stroke

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