Clinical trial NCT04436770: Medical Recovery and Social Reintegration for Post-stroke Patients Using Virtual Reality
Official title: Medical Recovery and Social Reintegration for Post-stroke Patients With Sequelae Using Virtual Reality
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke Sequelae
Keywords: Virtual Reality
Physiotherapy
Recovery
Lead sponsor: Transilvania University of Brasov
Sponsor class: OTHER
Collaborators: name: Spitalul Clinic de Psihiatrie si Neurologie Brasov
First posted: 2020-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
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.
timeFrame: One year since the beginning of the research
Secondary outcomes:
measure: 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.
timeFrame: One year since the beginning of the research
Other outcomes:
Locations:
city: Braşov
country: Romania
facility: Clinical Hospital of Psychiatry and Neurology
state: Brasov
Study officials:
References: