Effects of Virtual Reality Training for Stroke Patients

NCT ID: NCT05178758

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-09-30

Brief Summary

To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2) to compare the outcome measures of the two groups of stroke patients (VR-intervention vs. conventional-control) on these two modes of training.

Detailed Description

After being informed about the study and potential risks, all participants who gave written consent will undergo the study. A randomized controlled trial with pre-/post-study, of 42 stroke patients with upper limb weakness (21 patients in the control group and 21 patients in the intervention group), 18-65 years old, all are newly admitted stroke patients in the rehabilitation clinic from one hospital. Participants in the intervention group will receive 60 minutes of VR training to improve upper limb function and daily living activities. Participants in the control group will receive 60 minutes of conventional training to improve upper limb function and daily living activities. The training includes grasp, grip, pinch, gross, and finger-hand coordination movement. The training will perform 5 times/week for 4 weeks. Two outcome measures: (a) The Barthel Index and (b) The Fugl-Meyer Assessment, time spent to complete a task were used to compare two groups.

Conditions

Stroke Patients

Study Design

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

Study Groups

Virtual Reality (VR) Rehabilitation Training

Patients in the VR group will receive VR rehabilitation training in the hospital. The content of the training is the same as the control group. The only difference is that participants in the intervention group will use VR as a training platform. The VR system will include the training materials and tasks required for the patients to perform in the 3D environment. Demographic, clinical data and treatment costs will be collected before and after the rehabilitation training.

Group Type: EXPERIMENTAL

Virtual Reality (VR)

Intervention Type: DEVICE

Patients in the intervention (VR) group will receive a series of occupational and physical therapy rehabilitation training using the VR system. All training is consists of daily activities oriented by an occupational therapist, including grasp, grip, pinch, gross, and finger-hand coordination movement. Each training will take around 1 hour for one session per day 5 times per week over a maximum of 4 weeks. The training presented a one-on-one that allowed interaction between instructor (or VR system) and participant.

Control - Conventional Rehabilitation Training

Patients in the control group will receive conventional rehabilitation training currently provided in the hospital. An instructor will assign each participant for training. Demographic, clinical data, and treatment costs will be collected before and after completing the rehabilitation training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality (VR)

Patients in the intervention (VR) group will receive a series of occupational and physical therapy rehabilitation training using the VR system. All training is consists of daily activities oriented by an occupational therapist, including grasp, grip, pinch, gross, and finger-hand coordination movement. Each training will take around 1 hour for one session per day 5 times per week over a maximum of 4 weeks. The training presented a one-on-one that allowed interaction between instructor (or VR system) and participant.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. New in-patients clinically diagnosed hemiparetic stroke patients;

2. Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;

3. muscle strength > 2/5 on the Medical Research Council (MRC) scale;

4. good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and

5. ability to communicate and sign the consent.

Exclusion Criteria

1. In-patient with ataxia or any other cerebellar symptoms;

2. orthopedic alterations or pain syndrome of the upper limb;

3. peripheral nerve damage affecting the upper extremities;

4. visual or hearing impairment (does not allow the possibility of interaction with the VR system);

5. severe hemispatial neglect;

6. severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);

7. insensate forearm and /or hand, edema of the affected forearm and /or hand;

8. uncontrolled seizures disorder;

9. severe depression (>13 on beck Depression inventory fast screen); and

10. severely impaired cognition or comprehension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Moon Fai Chan, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moon Fai Chan

Role: PRINCIPAL_INVESTIGATOR

Sultan Qaboos University

Central Contacts

Moon Fai Chan

Role: CONTACT

moonf@squ.edu.om

+968 24141132

Hamdan Al Habsi

Role: CONTACT

habsi@squ.edu.om

+968 24141128

Other Identifiers

MREC #2593

Identifier Type: -

Identifier Source: org_study_id