Subacute StrokeNCT06720194
Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
A study testing Virtual therapy and Usual treatment in people with Subacute Stroke, run by Lorena Aguilar Cano at 1 site in Spain.
Trial summary
The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- Virtual therapy and Usual treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2020to 3 Apr 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke confirmed by neuroimaging.
- No previous stroke.
- Subacute phase (between 1 and 6 months after the stroke).
- Ability to sit with or without support.
- Maximum 4 on the Muscle Strength Scale (MRC) for shoulder flexion and flexion-extension of the elbow of the upper limb on the affected side.
- Ability to understand and accept study procedures and to sign an informed consent having been previously informed.
Who cannot join
- Previous history of brain injury, stroke and neurological or neuropsychiatric diseases.
- Cognitive alterations, dementia, aphasia or other alteration that causes inability to understand the meaning of the study.
- Clinical inestability
- Loss of visual capacity that difficults recognizing figures on the screen.
- Orthopedic conditions involving upper limbs.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.
Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.
Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.
When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.
- Conditions
- Subacute Stroke
- Being tested
- Virtual therapy, Usual treatment
- Keywords
- stroke rehabilitation, upper limb recovery, physical therapy, virtual reality therapy, daily-life activities, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual therapyDevice
Virtual therapy has been applied for four weeks, three times a week. We administered a total of twelve sessions with a duration of 30 minutes each. Prior to virtual therapy experimental group have received kinesitherapy for 15 minutes to improve and prevent muscle spasticity and joint contractures. Therapists recorded the order of the session and they have providen the same external aid to all patients. Two days a week the experimental group have received the conventional treatment for 45 minutes (kinesitherapy, strengthening exercises muscle, trunk control, transfers, standing and walking). In addition to physiotherapy treatment, participants have done occupational therapy 5 days a week (training to perform ADLs, tracking techniques and search, manipulation, reach and grasping of different utensils, etc.), for 30 minutes each session.
Usual treatmentOther
Patients assigned to the control group have received the conventional treatment five days a week. They have done physiotherapy session and occupational therapy for 45 and 30 minutes a day each one.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This arm receives the virtual therapy plus the usual treatment Receives: Device: Virtual therapy |
| Control Group | Other | This arm receives the usual treatment at the same dose and time than experimental group Receives: Other: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)
The maximum value of the motor function in the FM-UL scale is 66 points. A higher score corresponds to a better state of operation of the patient.
Measured: at baseline, 4 weeks, 3 months and a year after treatment
Secondary outcomes (3)
Daily-life activities as assessed as Barthel Index (BI)
BI evaluates 10 daily-life activities: eating, wash, dress, groom, defecate, urinate, go to the toilet, move, chair-bed, ambulation, going up and down stairs. The total score ranges from 0 to 100. The global results are grouped into four categories of dependency: total, severe, moderate or mild. Lower score means subject has more dependence ant higher score means more independence.
Measured: at baseline, 4 weeks, 3 months and a year after treatment
Trunk control as assessed as Control Trunk Test (TCT)
TCT is a simple test that explores four movements. Each of the sections are scored as follows: 0 points if the patient is unable to perform the movement without assistance, 12 points if able to perform the movement abnormally and 25 points if the patient is able to complete the movement normally. The total score is the sum of the results of the four tests and its value can range from 0 to 100.
Measured: at baseline, 4 weeks, 3 months and a year after treatment
Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM)
SARA-TM is a questionnaire that users fill out with the orientation of the therapists. It is based on their perceptions of various daily-life activities. We have asked about items related to self-care, food, maintenance of postures, movement, manipulation and pain. Each one of the domains consists of different items that correspond to different activities. Each item is scored from 0 to 4 depending on the degree of difficulty in performing the activities. Lower values represent better function
Measured: at baseline, 4 weeks, 3 months and a year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start17 Nov 2020
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lorena Aguilar Cano
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Responsible party
- Sponsor-investigator, Lorena Aguilar Cano, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720194
- Sponsor's protocol ID
- RVACV2020
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper-limb Functional Recovery With Virtual Reality System (BTs-Nirvana) Associated With Conventional Therapy in Hospitalized Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT06720194
- Acronym / sponsor ID
- RVACV2020
- Conditions
- Subacute Stroke
- Keywords
- stroke rehabilitation, upper limb recovery, physical therapy, virtual reality therapy, daily-life activities, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lorena Aguilar CanoUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 6 Dec 2024 (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.
The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.
Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.
Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.
When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Virtual therapyThis arm receives the virtual therapy plus the usual treatment |
| Control Group | Other | Other: Usual treatmentThis arm receives the usual treatment at the same dose and time than experimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic or hemorrhagic stroke confirmed by neuroimaging.
- No previous stroke.
- Subacute phase (between 1 and 6 months after the stroke).
- Ability to sit with or without support.
- Maximum 4 on the Muscle Strength Scale (MRC) for shoulder flexion and flexion-extension of the elbow of the upper limb on the affected side.
Key exclusion criteria (6 listed)
- Previous history of brain injury, stroke and neurological or neuropsychiatric diseases.
- Cognitive alterations, dementia, aphasia or other alteration that causes inability to understand the meaning of the study.
- Clinical inestability
- Loss of visual capacity that difficults recognizing figures on the screen.
- Orthopedic conditions involving upper limbs.
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 therapyVirtual therapy has been applied for four weeks, three times a week. We administered a total of twelve sessions with a duration of 30 minutes each. Prior to virtual therapy experimental group have received kinesitherapy for 15 minutes to improve and prevent muscle spasticity and joint contractures. Therapists recorded the order of the session and they have providen the same external aid to all patients. Two days a week the experimental group have received the conventional treatment for 45 minutes (kinesitherapy, strengthening exercises muscle, trunk control, transfers, standing and walking). In addition to physiotherapy treatment, participants have done occupational therapy 5 days a week (training to perform ADLs, tracking techniques and search, manipulation, reach and grasping of different utensils, etc.), for 30 minutes each session. | Device | Experimental group |
| Usual treatmentPatients assigned to the control group have received the conventional treatment five days a week. They have done physiotherapy session and occupational therapy for 45 and 30 minutes a day each one. | Other | Control Group |
Primary outcome
Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL)
Time frame: at baseline, 4 weeks, 3 months and a year after treatment
The maximum value of the motor function in the FM-UL scale is 66 points. A higher score corresponds to a better state of operation of the patient.
3 secondary outcomes
Daily-life activities as assessed as Barthel Index (BI)
Time frame: at baseline, 4 weeks, 3 months and a year after treatment
Trunk control as assessed as Control Trunk Test (TCT)
Time frame: at baseline, 4 weeks, 3 months and a year after treatment
Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM)
Time frame: at baseline, 4 weeks, 3 months and a year after treatment
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 6 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Subacute Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
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RecruitingObservational study
Analysis of Electroencephalogram (EEG) Changes in Subacute Stroke Patients
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Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy and Usual treatment in people with Subacute Stroke, run by Lorena Aguilar Cano 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 6 inclusion and 6 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 6 Dec 2024. 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?
Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL) (time frame: at baseline, 4 weeks, 3 months and a year after treatment). 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 6 Dec 2024.