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NCT Number: NCT07029061

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

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.

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Key information

Conditions

Stroke Sequelae Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alicia

Madrid, 28007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air splints

Device

Application of CPPS (Urias splints) + physiotherapy

Primary outcomes

  1. Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)

    Time frame: Baseline and post 4-week intervention

    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.

Secondary outcomes

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

    Time frame: Baseline and after 4-week intervention

    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.

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

    Time frame: Baseline and after 4-week intervention

    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.

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

    Time frame: Baseline and after 4-week intervention

    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.

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

    Time frame: Baseline and after 4-week intervention

    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.

Sponsors and collaborators

Lead sponsor

Alfonso X El Sabio University

Other

Collaborators

  • Hospital Beata María Ana

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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