Stroke SequelaeNCT07029061
Effect of Air Splints on Sensoriomotor Disturbances of the Affected Upper Extremity and Trunk Control in the Adult Post-stroke Patient
A study testing Air splints in people with Stroke Sequelae, run by Alfonso X El Sabio University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Air splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2020to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke at least 2 months earlier
- Mild/moderate hypertonia (Ashworth ≤3)
- Proprioceptive and exteroceptive deficits
- Trunk stability score between 8-23 (TCT)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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
- Being tested
- Air splints
- Keywords
- Physical Therapy, Air splints, Stroke, Upper Limb, Sensorimotor impairments
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air splintsDevice
Application of CPPS (Urias splints) + physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device | Experimental | Not described Receives: Device: Air splints |
| Physiotherapy alone following neurodevelopmental approach | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post 4-week intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start12 Jun 2020
- Primary completion12 Jun 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfonso X El Sabio University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Beata María Ana
- Responsible party
- Principal investigator, Alicia Hernando Rosado, Alfonso X El Sabio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029061
- Sponsor's protocol ID
- Universidad Alfonso X El Sabio
- Status last verified
- Jan 2024
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07029061
- Acronym / sponsor ID
- Universidad Alfonso X El Sabio
- Conditions
- Stroke Sequelae
- Keywords
- Physical Therapy, Air splints, Stroke, Upper Limb, Sensorimotor impairments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alfonso X El Sabio UniversityUniversity, hospital or other
- Collaborators
- Hospital Beata María Ana
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device | Experimental | Device: Air splints |
| Physiotherapy alone following neurodevelopmental approach | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke at least 2 months earlier
- Mild/moderate hypertonia (Ashworth ≤3)
- Proprioceptive and exteroceptive deficits
- Trunk stability score between 8-23 (TCT)
Key exclusion criteria (6 listed)
- Non-vascular etiology
- Clinical instability
- Skin lesions or deformities
- Botulinum toxin in last 3 months
- Cognitive/communication limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air splintsApplication of CPPS (Urias splints) + physiotherapy | Device | Application of CPPS (Urias splints) + physiotherapy Intervention Type: Device |
Primary outcome
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.
4 secondary outcomes
Change in trunk function measured by the Trunk Control Test (TCT)
Time frame: Baseline and after 4-week intervention
Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline and after 4-week intervention
Change in hand strength (flexion and extension) 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.
Time frame: Baseline and after 4-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air splints in people with Stroke Sequelae, run by Alfonso X El Sabio University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.