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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART Glove system with dual-tDCS | Experimental | VR-based SMART Glove system with dual-tDCS |
|
| SMART Glove system with sham-tDCS | Sham Comparator | VR-based SMART Glove system with sham-tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMART Glove system with tDCS | Device | combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Box and block test | Change of box and block test scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer assessment of the upper extremity (FMA) | Change of FMA scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) |
| Jebsen Taylor Hand Function Test (JTT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joon-Ho Shin, MS | Contact | 82-2-901-1884 | asfreelyas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Joon-Ho Shin, MS | National Rehabilitation Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Rehabilitation Center | Recruiting | Seoul | 142884 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| SMART Glove system with sham-tDCS | Device | combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. |
|
Change of JTT scores
| baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) |
| Grip strength | Change of Grip strength (JAMAR) scores | baseline (T0), pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2), and at 4 weeks post-intervention (T3) |
| Stroke Impact Scale (SIS) | Change of SIS scores | pre-intervention after 1 week of baseline (T1), after 5 weeks of intervention (T2) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |