Clinical trial NCT02013999: The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients
Official title: Mobile Game-based Virtual Reality Rehabilitation Program for Upper Limb Dysfunction After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Dysfunction After the Stroke
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.

Detailed description: This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity \[FMA-UE\], Brunnstr¨om stage \[B-stage\] for the arm and the hand, manual muscle testing \[MMT\], modified Barthel index \[MBI\], EuroQol-5 Dimension \[EQ-5D\], and Beck Depression Inventory \[BDI\]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.

Eligibility criteria: Inclusion Criteria:

* ischemic or hemorrhagic stroke confirmed by brain imaging study
* upper extremity dysfunction
* possible to use a simple device

Exclusion Criteria:

* delirium, confusion or other evidence related to the consciousness
* uncontrolled medical or surgical disease
* unable to command to the order due to severe cognitive impairment
* visual impairment
* unable to sit

Primary outcomes:
measure: Fugl-Meyer upper extremity scale
timeFrame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
Secondary outcomes:
measure: brunnström stage
timeFrame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
measure: Modified Barthel Index
timeFrame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
measure: Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
measure: Euroqol(EQ)-5D
timeFrame: baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks
measure: Virtual reality kinematic data
timeFrame: everytime when the patient uses program (automatically all recorded)
measure: questionnaire
timeFrame: at the end of the treatment for 2 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, South Korea
name: Nam-Jong Paik, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: