Clinical trial NCT04139980: Virtual Reality Device for Rehabilitation of Stroke Patients
Official title: Virtual Reality Device for Rehabilitation of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the potential efficacy and safety of using virtual reality gaming in conjunction to standard therapy regimen care as an approach to promote upper-limb motor recovery, cognitive function and quality of life after stroke. The investigators believe that allowing users to interact with a computer-simulated reality environment will result in a pleasant experience, which will likely result in motivation and therapy engagement.


Eligibility criteria: Inclusion Criteria:

* Patient admitted to the UAB Hospital, older than 18 years old, with a diagnosis of stroke
* Patient with unilateral upper extremity weakness
* Patients that after evaluation by Physical and Occupational professionals were admitted to rehabilitation facility "Spain Rehabilitation Center".

Exclusion Criteria:

* Patients with severe cognitive impairment
* Patient with orthopedic impairment (i.e. marked arthritis)
* Patient with visual disorders limiting therapy session
* Those for whom voluntary arm movement would cause sufficient discomfort (\>4/10) that could prevent trial completion will be excluded from participation.

Primary outcomes:
measure: Change in Upper-limb and hand motor function
timeFrame: Change from NIHSS measured at baseline visit, one week after final VR session, and three months following discharge. Totals are summed to determine the range:0= No stroke, 1-4 = Minor, 5-15 = Moderate, 15-20= Moderate to Severe; and 21-42 = Severe
measure: Change in upper-limb and hand motor function
timeFrame: Change from motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center
measure: Change in upper-limb and hand motor function
timeFrame: Change from Action Research Arm Test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center
measure: Change in upper-limb and hand motor function
timeFrame: Change from Nine hole Peg test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center
measure: Change in upper-limb and hand motor function
timeFrame: Change from Fugl-Meyer Assessment measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center
measure: Change in upper-limb and hand motor function
timeFrame: Change from m-RS measured at baseline, one wee following final VR session, and three months following discharge. The score is based on symptoms with a 0 provided for no symptoms up to a 5 provided for severe disability; bedridden, requires constant care.
Secondary outcomes:
measure: Change in cognitive function
timeFrame: Change from MOCA measured at baseline, one week following final VR session, and three months following discharge. The scores are summed. The range is: 27-30=Normal; 18-26=Mild impairment; 10-17=Moderate impairment; <10=Severe
measure: Change in activities of daily living (ADL) and quality of life
timeFrame: Change in SIS measured at baseline, one week after final VR session, and three months after discharge. Range is 0-100. Higher scores indicate better ADL and quality of life. Formula: Actual raw score - lowest possible score/Possible raw score)*100
measure: Change in depression
timeFrame: Change from PHQ9 measured at baseline, one week following final VR session, and three months following discharge. Scores are totaled with higher score being severe. 5-9 = Mild, 10-14 = Moderate, 15-19 = Moderately severe, 20-27 = Severe
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Spain Rehabilitation Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Chen Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: