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

Chronic Stroke Clinical Trial

Official title:

Effect of Virtual Reality Versus Conservative Treatment in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06459531
• Other study ID #: MSRSW/Batch-Fall22/723
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: November 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Pakistan	General hospital Jinnah hospital Mayo hospital Chaudhry Muhammad Akram Teaching and research hospital Services hospital Lahore (SHL)	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA) for Upper Extremity	The Fugl-Meyer Assessment (FMA) for Upper Extremity is a widely used and validated tool to evaluate motor function, balance, sensation, and joint functioning in individuals who have had a stroke. It specifically assesses the sensorimotor function of the upper extremities.	12 Months
Primary	Stroke Impact Scale (SIS)	The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates the impact of stroke on multiple dimensions, including strength, hand function, activities of daily living (ADL), mobility, communication, emotion, memory, thinking, and participation.; Scoring: Each item is scored on a scale of 1 to 5: 1: Unable to do 5: Not difficult at all Higher scores indicate a lesser impact of stroke on the patient's life.; Usage in the Study: Assessment Schedule: Administered at baseline and at the end of the intervention period.; Objective: To assess the overall impact of stroke on the patient's quality of life and participation in daily activities	12 months