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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Combination product: Virtual Reality (VR) Therapy; Diagnostic test: Conservative Treatment

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Services Hospital,Shadman 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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.

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).
• Other Neurological Conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Diagnostic test: Conservative Treatment; 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.
Experimental: Exp Group	Combination product: Virtual Reality (VR) Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Performs partially; 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

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MSRSW/Batch-Fall22/740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No