NCT07029061

Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient

Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient: A Pilot Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alfonso X El Sabio University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke Sequelae

Interventions

Type	Name	Description
DEVICE	Air splints	Application of CPPS (Urias splints) + physiotherapy

Timeline

• Start date: 2020-06-12
• Primary completion: 2022-06-12
• Completion: 2023-03-10
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Spain