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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprathreshold, subacute stroke | Experimental | Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPES, the patient will receive motor training. |
|
| Subthreshold, subacute stroke | Other | Other: Subthreshold RPSS + Motor Training. Subthreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training |
|
| Suprathreshold, chronic stroke | Experimental | Repetitive peripheral sensory stimulation (RPSS) + Motor Training. Suprathreshold RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training. |
|
| Subthreshold, chronic stroke | Other | Other: Subthreshold RPSS + Motor Training. RPSS will be administered for 2 hours. After RPSS, the patient will receive motor training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprathreshold repetitive peripheral sensory stimulation | Device | Suprathreshold repetitive peripheral sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For suprathreshold stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Jebsen-Taylor Test | Test of upper limb dexterity | Immediately after one session of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lateral pinch strength | Pinch strength measured with dynamometer | Immediately after one session of intervention |
| Change in gamma-aminobutyric acid levels in primary motor cortex | Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Rafael | Salvador | Estado de Bahia | 41253-190 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41911266 | Derived | Conforto AB, Neto RMA, Handfas B, Teixeira V, Zaiden J, Santos IO, Gava T, Pouza K, Reis SB, Silva GS, Amaro E Jr, da Guarda SNF. Divergent Effects of Repetitive Peripheral Stimulation in Subacute and Chronic Stroke: Results From the RESTORES Proof-of-Principle Randomized Trial. Neurorehabil Neural Repair. 2026 Jul;40(7):523-536. doi: 10.1177/15459683261426351. Epub 2026 Mar 30. | |
| 35250807 |
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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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An amendment for performance of a minimization procedure in order to enhance the probability of comparable characteristics between the groups was approved. The researcher responsible for minimization is not involved in data collection or analysis.
|
| Subthreshold repetitive sensory stimulation | Device | Subthreshold repetitive sensory stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For subthreshold stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required. |
|
| Immediately after one session of intervention |
| Change in brain perfusion | Brain perfusion measured with magnetic resonance imaging - arterial spin labeling | Immediately after one session of intervention |
| Change in grasp strength | Grasp strength measured with dynamometer | Immediately after one session of intervention |
| Derived |
| Kroth JB, Handfas B, Rodrigues G, Zepeda F, Oliveira MA, Wang DJJ, de Azevedo Neto RM, Silva GS, Amaro E Jr, Sorinola IO, Conforto AB. Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial. Front Neurol. 2022 Feb 16;13:779128. doi: 10.3389/fneur.2022.779128. eCollection 2022. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |