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SuspendedNCT04436770Updated Jun 18, 2020

Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality

An interventional study of Non-immersive virtual reality therapy and Standard Physiotherapy in Stroke Sequelae, sponsored by Transilvania University of Brasov. Suspended at 1 site in Romania. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-18.

Sponsored by Transilvania University of Brasov · Not applicable, Interventional, and Other

Why this study was suspended
Due to the COVID-19 pandemic

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2019, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Stroke with a site in Romania — 8 open to participants now, 10 under way, 4 of them phase 3. Stroke · Romania.

Enrollment
28th of 30
52 · median 6,420
Started
2019
with 1 other
No phase
7 of 36
4 open now
Registered
24th of 36
by date

Among the 36 studies in Stroke with a site in Romania, this one is the 28th largest by enrollment of the 30 interventional ones, is one of 2 that started in 2019, is one of 7 with no phase, and was the 24th registered.

By phase

36 studies; the count open now beside each. This study's row is marked.

Phase 319 · 1 open
No phasethis study7 · 4 open
Observational6 · 2 open
Phase 11 · 0 open
Phase 21 · 0 open
Phase 2/31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2000; this study’s year is marked. 2 started in 2019.

Size and results

Median enrollment 6,420 across the 30 interventional studies, 325 across the 6 observational. Of the 24 that completed or were terminated, 17 (71%) have results posted.

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02

Study 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 the detailed description
  1. Initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained.
  2. 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.
  3. 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).
  4. 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.
03

Conditions studied

  • Stroke Sequelae

Browse trials for

Keywords

  • Virtual Reality
  • Physiotherapy
  • Recovery
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. stroke survivors after the acute phase, at least 6 weeks post-stroke;
  2. stroke survivors within no more than 4 years after stroke,
  3. at least 30-degree flexion and scapulohumeral abduction against gravity.
  4. elbow flexion of at least 30 degrees
  5. hip flexion of at least 30 degrees
  6. knee flexion of at least 30 degrees

Exclusion criteria

Exclusion Criteria:

  1. no severe cognitive impairments,
  2. no global or transcortical sensory aphasia,
  3. no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain,
  4. no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain,
  5. without anaemia
  6. without atrial fibrillation
  7. without class IV heart failure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Control Group

    Standard physiotherapy and OT

    Other: Standard Physiotherapy

  • Experimental
    Experimental

    Virtual Reality Therapy and OT

    Other: Non-immersive virtual reality therapy

Interventions

  • OtherNon-immersive virtual reality therapy

    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.

    Also known as: Occupational therapy exercises

  • OtherStandard Physiotherapy

    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.

    Also known as: Occupational therapy exercises

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: One year since the beginning of the research

07

Study locations

1 site
  • Clinical Hospital of Psychiatry and Neurology
    Brasov, Brașov County 500123, Romania
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Feb 2020, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2020
First posted
Jun 18, 2020
StartActual
Jul 18, 2019
Primary completionActual
Feb 28, 2020
CompletionEst.
Dec 31, 2020
Last update
Jun 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04436770
Lead sponsor
Transilvania University of Brasov
Collaborators
Spitalul Clinic de Psihiatrie si Neurologie Brasov
Responsible party
Sponsor
First posted
Jun 18, 2020
Start date
Jul 18, 2019
Primary completion
Feb 28, 2020
Completion
Dec 31, 2020 (estimated)
Last update
Jun 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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