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NCT Number: NCT06568874

Effect of VR Versus CT 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Stroke

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital,Shadman 1

Lahore, Punjab Province, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA) for Upper Extremity

    Time frame: 12 Months

    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.

  2. Stroke Impact Scale (SIS)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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