StrokeNCT05278403
Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
A study testing Virtual reality and video games and Neurological physiotherapy in people with Stroke and Virtual Reality, run by Universidad de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Virtual Reality, Physical Therapy
- What is being tested?
- Virtual reality and video games and Neurological physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2022to 13 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Stroke, Virtual Reality, Physical Therapy
- Being tested
- Virtual reality and video games, Neurological physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality and video gamesOther
Use of a software in stroke patients' rehabilitation.
Neurological physiotherapyOther
Application of conventional physical therapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Conventional neurological physiotherapy treatment. Receives: Other: Neurological physiotherapy |
| Experimental group | Experimental | Conventional neurological physiotherapy treatment with the use of virtual reality and video games. Receives: Other: Virtual reality and video games; Other: Neurological physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Strength measurement using the Daniels and Worthingham Scale. Minimum value = 0 , maximum value = 5. Higher scores mean a better outcome.
Measured: One month
Spasticity
Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.
Measured: One month
Gait
Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.
Measured: One month
Balance
Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.
Measured: One month
Joint range
Joint range measure using goniometer
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start6 May 2022
- Primary completion20 May 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two randomized groups. A control group and an experimental group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Martínez Carrasco, Universidad de Murcia
- Investigators
- Angel Martínez Carrasco, PhD, Study director, Universidad de MurciaFrancisco Javier Peláez Vélez, Graduated, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278403
- Sponsor's protocol ID
- JPV-2022-01
- Status last verified
- Jun 2022
- First submitted
- 3 Mar 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality and Video Games in the Physiotherapy Treatment of Stroke Patients
- ClinicalTrials.gov ID
- NCT05278403
- Acronym / sponsor ID
- JPV-2022-01
- Conditions
- Stroke, Virtual Reality, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two randomized groups. A control group and an experimental group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Neurological physiotherapyConventional neurological physiotherapy treatment. |
| Experimental group | Experimental | Other: Virtual reality and video games, Other: Neurological physiotherapyConventional neurological physiotherapy treatment with the use of virtual reality and video games. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality and video gamesUse of a software in stroke patients' rehabilitation. | Other | Experimental group |
| Neurological physiotherapyApplication of conventional physical therapy techniques. | Other | Control group, Experimental group |
Primary outcome
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.
Spasticity
Time frame: One month
Spasticity measurement using the Ashworth modified scale. Minimum value = 0, maximum value = 4. Higher scores mean a worse outcome.
Gait
Time frame: One month
Gait measurement using the Tinetti scale. Minimum value = 0, maximum value = 28. Higher scores mean a better outcome.
Balance
Time frame: One month
Balance using the Berg Balance Scale. Minimum value = 0, maximum value = 56. Higher scores mean a better outcome.
Joint range
Time frame: One month
Joint range measure using goniometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Martínez Carrasco, PhD study director
Universidad de Murcia
Francisco Javier Peláez Vélez, Graduated principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and video games and Neurological physiotherapy in people with Stroke and Virtual Reality, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: One month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.