Stroke SequelaeNCT04436770
Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality
A study testing Non-immersive virtual reality therapy and Standard Physiotherapy in people with Stroke Sequelae, run by Transilvania University of Brasov at 1 site in Romania.
Trial summary
Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Non-immersive virtual reality therapy and Standard Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteRomania
- Study dates
- 18 Jul 2019to 31 Dec 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke survivors after the acute phase, at least 6 weeks post-stroke;
- stroke survivors within no more than 4 years after stroke,
- at least 30-degree flexion and scapulohumeral abduction against gravity.
- elbow flexion of at least 30 degrees
- hip flexion of at least 30 degrees
- knee flexion of at least 30 degrees
Who cannot join
- no severe cognitive impairments,
- no global or transcortical sensory aphasia,
- no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
- no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
- without anaemia
- without atrial fibrillation
- without NYHA class IV heart failure
Trial locations and contacts
1 site in 1 country.
Romania1 site
Clinical Hospital of Psychiatry and Neurology
Brasov, Brașov County, 500123
About this study
Official title: Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.
Read the detailed description
- Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained.
- Collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the Clinical Hospital of Psychiatry and Neurology in Brasov.
- Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders).
- Use of data obtained from the application of Virtual Reality therapy at home, through Telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the Virtual Reality therapy program at home, taking into account that the technology purchased through the project allows this.
- Conditions
- Stroke Sequelae
- Being tested
- Non-immersive virtual reality therapy, Standard Physiotherapy
- Keywords
- Virtual Reality, Physiotherapy, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-immersive virtual reality therapyOther
Also called Occupational therapy exercises
Non-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity.
For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes.
For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes.
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used.
Standard PhysiotherapyOther
Also called Occupational therapy exercises
Standard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity.
For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
For the ankle and foot, analytical and dexterity exercises were used.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard physiotherapy and OT Receives: Other: Standard Physiotherapy |
| Experimental | Experimental | Virtual Reality Therapy and OT Receives: Other: Non-immersive virtual reality therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality.
The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG).
The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.
Measured: One year since the beginning of the research
Secondary outcomes (1)
The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.
Collecting data related to age, gender, time after stroke, other conditions present (such as hypertension, dyslipidemia, diabetes, ischemic coronary disease, etc.) and determining the links between post-stroke recovery capacity and these factors using statistical software programs and analysis.
Measured: One year since the beginning of the research
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start18 Jul 2019
- Primary completion28 Feb 2020
- Study completion31 Dec 2020 (estimated)
Why it stopped: Due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transilvania University of Brasov
- Sponsor type
- University, hospital or other
- Collaborators
- Spitalul Clinic de Psihiatrie si Neurologie Brasov
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436770
- Sponsor's protocol ID
- 13/8.02.2018
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 18 Jun 2020
- 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 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
- ClinicalTrials.gov ID
- NCT04436770
- Acronym / sponsor ID
- 13/8.02.2018
- Conditions
- Stroke Sequelae
- Keywords
- Virtual Reality, Physiotherapy, Recovery
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to the COVID-19 pandemic
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Transilvania University of BrasovUniversity, hospital or other
- Collaborators
- Spitalul Clinic de Psihiatrie si Neurologie Brasov
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Jun 2020 (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.
Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.
Detailed description
- Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained.
- Collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the Clinical Hospital of Psychiatry and Neurology in Brasov.
- Application of Virtual Reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders).
- Use of data obtained from the application of Virtual Reality therapy at home, through Telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the Virtual Reality therapy program at home, taking into account that the technology purchased through the project allows this.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard PhysiotherapyStandard physiotherapy and OT |
| Experimental | Experimental | Other: Non-immersive virtual reality therapyVirtual Reality Therapy and OT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- stroke survivors after the acute phase, at least 6 weeks post-stroke;
- stroke survivors within no more than 4 years after stroke,
- at least 30-degree flexion and scapulohumeral abduction against gravity.
- elbow flexion of at least 30 degrees
- hip flexion of at least 30 degrees
Key exclusion criteria (7 listed)
- no severe cognitive impairments,
- no global or transcortical sensory aphasia,
- no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
- no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
- without anaemia
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 |
|---|---|---|
| Non-immersive virtual reality therapyAlso: Occupational therapy exercisesNon-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity. For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes. For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes. The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks. For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used. | Other | Experimental |
| Standard PhysiotherapyAlso: Occupational therapy exercisesStandard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity. For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises. For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises. The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks. For the ankle and foot, analytical and dexterity exercises were used. | Other | Control Group |
Primary outcome
The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae.
Time frame: One year since the beginning of the research
Determining the factors and parameters that influence or enhance post-stroke recovery capacity using new recovery methods, such as non-immersive virtual reality. The assessment tools are: the Fugl-Meyer assessment for the upper extremity (FMUE), Fugl-Meyer assessment for the lower extremity (FMLE), the Modified Rankin Scale (MRS), the Functional Independence Measure (FIM), the Active Range of Motion (AROM), the Manual Muscle Testing (MMT), the Modified Ashworth Scale (MAS), the Functional Reach Test (FRT), and Timed Up and Go Test (TUG). The patients are assessed by recovery medical doctors (physiatrists) regarding FIM, MAS and MRS. While FMUE, FMLE, AROM, MMT, FRT, TUG are assessed by trained physiotherapists, with at least 5 years of experience in stroke sequelae physiotherapy and evaluation.
1 secondary outcome
The number of patients for whom heart disease and other elderly condition, age or gender are influencing the capacity to the recovery of post-stroke patients.
Time frame: One year since the beginning of the research
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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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 Non-immersive virtual reality therapy and Standard Physiotherapy in people with Stroke Sequelae, run by Transilvania University of Brasov at 1 site in Romania.
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 7 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: paused, as of the sponsor's last update on 18 Jun 2020. 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 Romania. 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?
Results are not available in the source record.
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?
The number of patients for whom tailored Virtual Reality therapy is more efficient than standard tailored physiotherapy in the recovery of post-stroke sequelae. (time frame: One year since the beginning of the research). 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 18 Jun 2020.