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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436770
Recruitment Status : Suspended (Due to the COVID-19 pandemic)
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Spitalul Clinic de Psihiatrie si Neurologie Brasov
Information provided by (Responsible Party):
Transilvania University of Brasov

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Sequelae Other: Non-immersive virtual reality therapy Other: Standard Physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
Actual Study Start Date : July 18, 2019
Actual Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: Control Group
Standard physiotherapy and OT
Other: Standard 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.

Other Name: Occupational therapy exercises

Experimental: Experimental
Virtual Reality Therapy and OT
Other: Non-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.

Other Name: Occupational therapy exercises




Primary Outcome Measures :
  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. [ 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.



Secondary Outcome Measures :
  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. [ Time Frame: One year since the beginning of the research ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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 NYHA class IV heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436770


Locations
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Romania
Clinical Hospital of Psychiatry and Neurology
Braşov, Brasov, Romania, 500123
Sponsors and Collaborators
Transilvania University of Brasov
Spitalul Clinic de Psihiatrie si Neurologie Brasov
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Responsible Party: Transilvania University of Brasov
ClinicalTrials.gov Identifier: NCT04436770    
Other Study ID Numbers: 13/8.02.2018
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Transilvania University of Brasov:
Virtual Reality
Physiotherapy
Recovery
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases