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| Name | Class |
|---|---|
| Hospital Beata María Ana | OTHER |
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Objective: Sensory impairment in the affected upper limb occurs in approximately 50% of post-stroke patients and negatively impacts functional capacity and quality of life. This pilot study aims to evaluate whether the standardized use of pneumatic (air) splints, as part of a neurodevelopmental treatment approach, will have a positive effect on sensorimotor deficits in the hemiplegic upper limb of post-stroke patients.
Design: Pilot randomized, single-blind clinical trial.
Setting: Brain injury rehabilitation facility.
Participants: Twenty adults in the subacute phase after stroke will be randomized into two groups. The experimental group (n = 10) will receive air splint therapy combined with physiotherapy (45 minutes per session, twice per week for 4 weeks). The control group (n = 10) will receive only physiotherapy with the same duration and frequency. Sensorimotor outcomes will be assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), and finger flexor/extensor strength will be measured using the Amadeo robotic system. Assessments will be conducted before and after the intervention.
Conclusions: The addition of air splints to physiotherapy may enhance exteroceptive and proprioceptive sensitivity in adults recovering from stroke during the subacute phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device | Experimental |
| |
| Physiotherapy alone following neurodevelopmental approach | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Air splints | Device | Application of CPPS (Urias splints) + physiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) | Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), a validated stroke-specific scale. The FMA-UE ranges from 0 to 66, where higher scores indicate better motor and sensory function. | Baseline and post 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in trunk function measured by the Trunk Control Test (TCT) | Change in trunk function measured by the Trunk Control Test (TCT), which assesses four functional movements. The TCT ranges from 0 to 100, where higher scores indicate better trunk control and functional ability. | Baseline and after 4-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alicia | Madrid | Madrid | 28007 | Spain |
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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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| Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest) |
Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest), which ranges from 0 to 28. Higher scores indicate better dynamic balance. |
| Baseline and after 4-week intervention |
| Change in hand strength (flexion and extension) measured using the AMADEO robotic system. | Change in hand strength (flexion and extension) measured using the AMADEO robotic system. Strength will be recorded in Newtons (N). Higher values indicate greater muscle strength. | Baseline and after 4-week intervention |
| Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system. | Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system. ROM will be recorded in degrees (°). Higher values indicate better joint mobility. | Baseline and after 4-week intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |