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

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.

Study Overview

• Status: Completed
• Conditions: Stroke Sequelae
• Intervention / Treatment: Device: Air splints

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Alicia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device	Device: Air splints; Application of CPPS (Urias splints) + physiotherapy
No Intervention: Physiotherapy alone following neurodevelopmental approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Alfonso X El Sabio University
• Collaborators: Hospital Beata María Ana

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): June 12, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Physical Therapy; Upper Limb; Air splints; Sensorimotor impairments
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Universidad Alfonso X El Sabio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No