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

NCT07029061 | Completed DMC

• 1 other identifier: Universidad Alfonso X El Sabio
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Physical Therapy; Air splints; Stroke; Upper Limb; Sensorimotor impairments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in trunk function measured by the Trunk Control Test (TCT)

  Baseline and after 4-week intervention

• Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)

  Baseline and after 4-week intervention

• Change in hand strength (flexion and extension) measured using the AMADEO robotic system.

  Baseline and after 4-week intervention

• Change in range of motion (ROM) of the shoulder and fingers measured using the AMADEO robotic system.

  Baseline and after 4-week intervention

Study Arms (2)

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

EXPERIMENTAL

Device: Air splints

Physiotherapy alone following neurodevelopmental approach

NO INTERVENTION

Interventions

Air splints DEVICE

Application of CPPS (Urias splints) + physiotherapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alfonso X El Sabio University: lead
• Hospital Beata María Ana: collaborator

Study Sites (1)

Alicia

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist (PhD)

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 12, 2020
• Primary Completion: June 12, 2022
• Study Completion: March 10, 2023
• Last Updated: June 19, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)