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

NCT ID: NCT07029061

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-12
• Study Completion Date: 2023-03-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Air splints

Intervention Type: DEVICE

Application of CPPS (Urias splints) + physiotherapy

Physiotherapy alone following neurodevelopmental approach

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Air splints

Application of CPPS (Urias splints) + physiotherapy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Beata María Ana

OTHER

Sponsor Role: collaborator

Alfonso X El Sabio University

OTHER

Sponsor Role: lead

Responsible Party

Alicia Hernando Rosado

Physiotherapist (PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alicia

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

Universidad Alfonso X El Sabio

Identifier Type: -

Identifier Source: org_study_id