Clinical trial NCT03465631: Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation
Official title: Distal Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation (tDCS) for Stroke Patients : a Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2018-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Box and block test
timeFrame: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
Secondary outcomes:
measure: Fugl-Meyer assessment of the upper extremity (FMA)
timeFrame: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
measure: Jebsen Taylor Hand Function Test (JTT)
timeFrame: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
measure: Grip strength
timeFrame: baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3)
measure: Stroke Impact Scale (SIS)
timeFrame: pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References: