- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05278403
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
June 21, 2022 updated by: Angel Martínez Carrasco, Universidad de Murcia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Murcia, Spain, 300100
- Universidad de Murcia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Conventional neurological physiotherapy treatment.
|
Application of conventional physical therapy techniques.
|
|
Experimental: Experimental group
Conventional neurological physiotherapy treatment with the use of virtual reality and video games.
|
Application of conventional physical therapy techniques.
Use of a software in stroke patients' rehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: One month
|
Strength measurement using the Daniels and Worthingham Scale.
Minimum value = 0 , maximum value = 5.
Higher scores mean a better outcome.
|
One month
|
|
Spasticity
Time Frame: One month
|
Spasticity measurement using the Ashworth modified scale.
Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.
|
One month
|
|
Gait
Time Frame: One month
|
Gait measurement using the Tinetti scale.
Minimum value = 0, maximum value = 28.
Higher scores mean a better outcome.
|
One month
|
|
Balance
Time Frame: One month
|
Balance using the Berg Balance Scale.
Minimum value = 0, maximum value = 56.
Higher scores mean a better outcome.
|
One month
|
|
Joint range
Time Frame: One month
|
Joint range measure using goniometer
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Angel Martínez Carrasco, PhD, Universidad de Murcia
- Principal Investigator: Francisco Javier Peláez Vélez, Graduated, Universidad de Murcia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2022
Primary Completion (Actual)
May 20, 2022
Study Completion (Actual)
June 13, 2022
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 22, 2022
Last Update Submitted That Met QC Criteria
June 21, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JPV-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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