Effect of VR VS Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients

NCT ID: NCT06459531

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-11-01

Brief Summary

Virtual reality (VR) therapy has shown promising results in improving sensorimotor function of the upper extremity in chronic stroke patients compared to conservative treatments. VR offers immersive, interactive environments that can enhance motivation and engagement in rehabilitation exercises. Studies have indicated that VR can lead to significant improvements in motor function, coordination, and strength of the affected upper limb.

Detailed Description

These advancements are often attributed to the ability of VR to provide real-time feedback, varied and repetitive tasks, and the stimulation of neuroplasticity. In contrast, conservative treatments, such as traditional physical and occupational therapy, though beneficial, may not offer the same level of stimulation and engagement. Overall, VR therapy can be a valuable adjunct to traditional rehabilitation, potentially accelerating recovery and improving functional outcomes for chronic stroke patients by providing a more dynamic and engaging approach to therapy.

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Virtual Reality (VR) Therapy

Group Type: EXPERIMENTAL

Virtual Reality (VR) Therapy

Intervention Type: BEHAVIORAL

Patients in this group will receive therapy using VR technology. This involves engaging in various sensorimotor training exercises and tasks in an immersive virtual environment. The VR sessions are designed to be interactive and adaptive, providing real-time feedback to the user. The exercises will target the improvement of motor functions, coordination, and strength of the affected upper extremity.

Duration and Frequency: The specific regimen may involve sessions several times a week, with each session lasting between 30 to 60 minutes, over a period of several weeks or months, depending on the study design.

Conservative Treatment

Group Type: OTHER

Conservative Treatment

Intervention Type: OTHER

Patients in this group will receive traditional rehabilitation therapies, which may include:

Physical Therapy (PT): Exercises and activities aimed at improving strength, flexibility, and coordination of the upper limb.

Occupational Therapy (OT): Functional task training to enhance daily living skills and independence, focusing on the use of the upper extremity.

Manual Therapy: Techniques such as massage or joint manipulation to improve mobility and reduce pain.

Home Exercise Programs: Prescribed exercises to be performed at home to reinforce therapy sessions.

Duration and Frequency: Similar to the VR group, this regimen may involve regular sessions several times a week, with each session lasting between 30 to 60 minutes, over a comparable period.

Interventions

Virtual Reality (VR) Therapy

Patients in this group will receive therapy using VR technology. This involves engaging in various sensorimotor training exercises and tasks in an immersive virtual environment. The VR sessions are designed to be interactive and adaptive, providing real-time feedback to the user. The exercises will target the improvement of motor functions, coordination, and strength of the affected upper extremity.

Duration and Frequency: The specific regimen may involve sessions several times a week, with each session lasting between 30 to 60 minutes, over a period of several weeks or months, depending on the study design.

Intervention Type: BEHAVIORAL

Conservative Treatment

Patients in this group will receive traditional rehabilitation therapies, which may include:

Physical Therapy (PT): Exercises and activities aimed at improving strength, flexibility, and coordination of the upper limb.

Occupational Therapy (OT): Functional task training to enhance daily living skills and independence, focusing on the use of the upper extremity.

Manual Therapy: Techniques such as massage or joint manipulation to improve mobility and reduce pain.

Home Exercise Programs: Prescribed exercises to be performed at home to reinforce therapy sessions.

Duration and Frequency: Similar to the VR group, this regimen may involve regular sessions several times a week, with each session lasting between 30 to 60 minutes, over a comparable period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
• Adults aged 18 years and older.
• Demonstrable sensorimotor impairment of the upper extremity due to stroke, as assessed by clinical evaluation.
• Sufficient cognitive ability to follow instructions and participate in VR therapy, as determined by a Mini-Mental State Examination (MMSE) score of 24 or higher.
• Medically stable and able to participate in physical rehabilitation sessions, as cleared by a healthcare professional.

Exclusion Criteria

• Severe communication difficulties that would impede the ability to follow instructions during therapy.
• Severe spasticity in the affected upper limb (Modified Ashworth Scale score of 4 or higher)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General hospital Jinnah hospital Mayo hospital Chaudhry Muhammad Akram Teaching and research hospital Services hospital Lahore (SHL)

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/723

Identifier Type: -

Identifier Source: org_study_id