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

NCT06459531 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/723
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Virtual Reality (VR) Therapy

EXPERIMENTAL

Behavioral: Virtual Reality (VR) Therapy

Conservative Treatment

OTHER

Other: Conservative Treatment

Interventions

Virtual Reality (VR) Therapy 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.

Virtual Reality (VR) Therapy

Conservative Treatment 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.

Conservative Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

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

Lahore, Pakistan

Location

MeSH Terms

Interventions

Therapeutics; Conservative Treatment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)