Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02073773 | Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke | PHASE3 | COMPLETED | 9 | — | — | Jan 1, 2014 | Nov 1, 2015 | Feb 10, 2017 | 1 | Singapore |
Fugl Meyer Upper Extremity Scale (FM) - a clinical assessment of upper limb tone, power and movement.
| Arm | Type | Description |
|---|---|---|
| Virtual Reality based therapy, levodopa | EXPERIMENTAL | The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table. Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. |
| occupational therapy, levodopa | ACTIVE_COMPARATOR | The control group will receive and additional half an hour per working day of standard occupational therapy. Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before each additional Occupational therapy session or VR therapy session depending on the assigned group. |
| Name | Type | Description |
|---|---|---|
| Levodopa | DRUG | Levodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur. Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth. |
| Virtual Reality based therapy | OTHER | The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table. |
Inclusion Criteria: * Age: 25-99yrs * Right-handed * Cognitively coherent, able to provide informed consent (MMSE \>25) * Newly diagnosed, first episode ischemic stroke in the past 2-21 days * Motor score: Strength of 2-3 out of 5 on affected side upper limb Exclusion Criteria: * Declined consent...