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

Alfonso X El Sabio University

Status: Completed

Conditions: Stroke Sequelae

Treatments: Device: Air splints

Study type: Interventional

Funder types: Other

Identifiers

NCT07029061

Universidad Alfonso X El Sabio

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stroke at least 2 months earlier
• Mild/moderate hypertonia (Ashworth ≤3)
• Proprioceptive and exteroceptive deficits
• Trunk stability score between 8-23 (TCT)

Exclusion criteria

• Non-vascular etiology
• Clinical instability
• Skin lesions or deformities
• Botulinum toxin in last 3 months
• Cognitive/communication limitations
• Maximum TCT score (23) at baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device

Experimental group

Treatment:

Device: Air splints

Physiotherapy alone following neurodevelopmental approach

No Intervention group