Stroke
Conditions
Keywords
stroke rehabilitation
Brief summary
The aim of this study to investigate the effect of combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. We hypothesized that experimental group (VR-based training with dual-tDCS) would improve distal upper extremity function rather than control group (VR-based training with dual sham tDCS).
Detailed description
This is a double-blind, randomized controlled study. Patients were randomly assigned to 1 : 1 ratio to experimental group (VR-based training with dual-tDCS; VR-Dual) or the control group (VR-based training with dual sham tDCS; VR-Sham) . For both conditions, VR-Dual and VR-Sham group commenced at the same time (20 minutes). The therapist and patients were blinded as to whether the patients received real or sham tDCS. The study was approved by the Ethics Committee of the National Rehabilitation Center, Korea, and all participants provided written informed consent before enrollment.
Interventions
DEVICESMART Glove system with tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
DEVICESMART Glove system with sham-tDCS
combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
Sponsors
National Rehabilitation Center, Seoul, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* first-time ischemic or hemorrhagic stroke * unilateral upper extremity functional deficits after stroke * presence of a score of at least 3 points on the Medical Research Council (MRC) * a score ≥ 4 on the Brunnstrom stage * a score ≥ 25 on the Korean version of the Mini-Mental Status Exam (K-MMSE)
Exclusion criteria
* age \< 20 years * wrist and finger spasticity with the Modified Ashworth Scale (MAS) score ≥ 2 * uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy * neurological disorders that cause motor deficits * being unable to perform the task or to understand instructions * presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and block test | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | Change of box and block test scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer assessment of the upper extremity (FMA) | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | Change of FMA scores |
| Jebsen Taylor Hand Function Test (JTT) | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | Change of JTT scores |
| Grip strength | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) | Change of Grip strength (JAMAR) scores |
| Stroke Impact Scale (SIS) | pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2) | Change of SIS scores |
Countries
South Korea
Contacts
Primary ContactJoon-Ho Shin, MS
Outcome results
None listed