Effect of VR Versus CT in Sensorimotor Function of Upper Extremity in Chronic Stroke Patients

NCT06568874 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/740
• 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.

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. Scoring: The upper extremity section of the FMA includes 33 items, each scored on a scale of 0 to 2: 0: Cannot perform 1. Performs partially 2. Performs fully The maximum score for the upper extremity section is 66, indicating optimal function.

  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. 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.

  12 months

Study Arms (2)

Exp Group

EXPERIMENTAL

Combination Product: Virtual Reality (VR) Therapy

Control Group

ACTIVE COMPARATOR

Diagnostic Test: Conservative Treatment

Interventions

Virtual Reality (VR) Therapy COMBINATION_PRODUCT

Intervention: 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.

Exp Group

Conservative Treatment DIAGNOSTIC_TEST

Intervention: 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.

Control Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with a confirmed diagnosis of chronic stroke (at least 6 months post-stroke).
• Age:
• Upper Extremity Impairment:
• Ability to provide informed consent to participate in the study.

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).
• Other Neurological Conditions

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Services Hospital,Shadman 1

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Therapeutics

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: August 21, 2024
• First Posted: August 23, 2024
• Study Start: November 30, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)