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

NCT ID: NCT04436770

Last Updated: 2020-06-18

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2020-12-31

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.

Conditions

Stroke Sequelae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control Group

Standard physiotherapy and OT

Group Type: ACTIVE_COMPARATOR

Standard Physiotherapy

Intervention Type: OTHER

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.

Experimental

Virtual Reality Therapy and OT

Group Type: EXPERIMENTAL

Non-immersive virtual reality therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Occupational therapy exercises; Occupational therapy exercises

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spitalul Clinic de Psihiatrie si Neurologie Brasov

UNKNOWN

Sponsor Role: collaborator

Transilvania University of Brasov

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Hospital of Psychiatry and Neurology

Brasov, Brașov County, Romania

Countries

Romania

Other Identifiers

13/8.02.2018

Identifier Type: -

Identifier Source: org_study_id