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

Transilvania University of Brasov

Status: Suspended

Conditions: Stroke Sequelae

Treatments: Other: Standard Physiotherapy; Other: Non-immersive virtual reality therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04436770

13/8.02.2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Standard physiotherapy and OT

Treatment:

Other: Standard Physiotherapy

Experimental

Experimental group

Description:

Virtual Reality Therapy and OT

Treatment:

Other: Non-immersive virtual reality therapy