Back to resultsUse of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Primary Purpose
Stroke, Virtual Reality, Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality and video games
Neurological physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients receiving neurological physiotherapy treatment.
- Patients who have suffered a stroke in the last two years.
- Patients with an age range between 18 and 80 years old.
- Patients with stroke with the ability to have minimal manual pressure with one limb.
Exclusion Criteria:
- Patients with stroke who also have degenerative diseases such as Alzheimer's or Parkinson's.
- Stroke patients who do not understand the instructions.
- Patients who have undergone surgery on the evaluated limbs.
- Patients with scars that limit movement.
Sites / Locations
- Universidad de Murcia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
Conventional neurological physiotherapy treatment.
Conventional neurological physiotherapy treatment with the use of virtual reality and video games.
Outcomes
Primary Outcome Measures
Strength
Strength measurement using the Daniels and Worthingham Scale. Minimum value = 0 , maximum value = 5. Higher scores mean a better outcome.
Spasticity
Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.
Gait
Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.
Balance
Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.
Joint range
Joint range measure using goniometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05278403
Brief Title
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Official Title
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Randomized clinical trial based on the application of virtual reality and video games together with physiotherapy treatment in stroke patients, with the main objective of determining their beneficial effects.
Detailed Description
21 participants who will be divided by randomization between a control group and an experimental group. The results will be quantified with the following scales: Modified Asworth (spasticity). Daniels et al (muscle strength) Tinetti (balance and gait) Berg (balance) Joint range
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Virtual Reality, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two randomized groups. A control group and an experimental group.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Randomized groups. Participants do not know to which group they are assigned. The other participants are unaware of the purpose of the study.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Conventional neurological physiotherapy treatment.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Conventional neurological physiotherapy treatment with the use of virtual reality and video games.
Intervention Type
Other
Intervention Name(s)
Virtual reality and video games
Intervention Description
Use of a software in stroke patients' rehabilitation.
Intervention Type
Other
Intervention Name(s)
Neurological physiotherapy
Intervention Description
Application of conventional physical therapy techniques.
Primary Outcome Measure Information:
Title
Strength
Description
Strength measurement using the Daniels and Worthingham Scale. Minimum value = 0 , maximum value = 5. Higher scores mean a better outcome.
Time Frame
One month
Title
Spasticity
Description
Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.
Time Frame
One month
Title
Gait
Description
Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.
Time Frame
One month
Title
Balance
Description
Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.
Time Frame
One month
Title
Joint range
Description
Joint range measure using goniometer
Time Frame
One month
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:
Patients receiving neurological physiotherapy treatment.
Patients who have suffered a stroke in the last two years.
Patients with an age range between 18 and 80 years old.
Patients with stroke with the ability to have minimal manual pressure with one limb.
Exclusion Criteria:
Patients with stroke who also have degenerative diseases such as Alzheimer's or Parkinson's.
Stroke patients who do not understand the instructions.
Patients who have undergone surgery on the evaluated limbs.
Patients with scars that limit movement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Martínez Carrasco, PhD
Organizational Affiliation
Universidad de Murcia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francisco Javier Peláez Vélez, Graduated
Organizational Affiliation
Universidad de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Murcia
City
Murcia
ZIP/Postal Code
300100
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
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