Clinical trial NCT03039764: Effects of Virtual Reality Based Rehabilitation in Acute Stroke Patients in an Inpatient Rehab Setting
Official title: The Comparison Study of Virtual Reality Rehabilitation With Standard Occupational Therapy Versus Standard Occupational Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke Syndrome
Hemiplegia
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of virtual reality-based rehabilitation (Neofect Glove) for newly diagnosed cognitively intact adult dominant hemisphere stroke patients with paresis of their hand in supplementation with conventional occupational therapy to assess whether it improves motor function and speed recovery during inpatient rehabilitation versus conventional occupational therapy alone. Also, what impact does this have on quality of life.

Detailed description: The American Stroke Association states that stroke is 5th leading cause of death in the United States and one of the leading causes of disability and loss of motor function. Approximately 80% of stroke survivors have upper extremity limitations where the distal upper extremity motor function is severely affected and is the last body part to recover. Restoration of arm function is essential to regaining activities of daily living (ADL) such as holding objects like utensils, turning a doorknob, writing or telephone use. Literature search shows that intensive and repetitive training may be necessary to modify neural organization and recover functional motor skills. Along with traditional rehabilitation methods, virtual reality (VR) based rehabilitation has emerged in recent years. VR-based rehabilitation is more intensive, of longer duration and more repetitive. Using VR rehabilitation, repetitive dull exercises can turn into a more challenging and motivating tasks such as games. Moreover, VR-based rehabilitation can provide a quantitative measure of the rehabilitation progress.

The investigators propose a study comparing conventional occupational services versus virtual reality-based rehabilitation intervention for participants during acute phase of stroke in the inpatient rehabilitation setting. The investigators hypothesize that by using VRA, will see a significant increase in the overall motor function, shorter hospital course and improved quality of life for the participants.

Eligibility criteria: Inclusion Criteria

* Minimum age of 18 years' old
* Unilateral upper extremity functional deficits after stroke
* First ever clinical diagnosis of stroke in the dominant hemisphere
* Diagnosis of ischemic or hemorrhagic stroke with unilateral paresis of dominant hand

Exclusion Criteria:

* Age less than 18 years' old
* Cognitive impairment resulting in inability to participate
* Severe aphasia resulting in inability to communicate to give consent or participate.

Primary outcomes:
measure: Number of participants treated with occupational therapy and with VR device will be assesed by Wolf Motor Function Test
timeFrame: 3 Months
Secondary outcomes:
measure: Number of participants treated with occupational therapy and with VR device will be assesed by Michigan Hand Outcome Questionnaire
timeFrame: 3 Months
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke rehabilitation Hospital
state: New York
Study officials:
References: