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Clinical Trials/NCT06459531
NCT06459531Active, not recruitingNot Applicable

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

Superior University1 site in 1 country33 target enrollmentStarted: November 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
33
Locations
1
Primary Endpoint
Fugl-Meyer Assessment (FMA) for Upper Extremity

Study Overview

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Virtual Reality (VR) Therapy

Experimental

Intervention: Virtual Reality (VR) Therapy (Behavioral)

Conservative Treatment

Other

Intervention: Conservative Treatment (Other)

Outcomes

Primary Outcomes

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.

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. 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Study Sites (1)

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