Stroke Sequelae
Conditions
Keywords
Physical Therapy, Air splints, Stroke, Upper Limb, Sensorimotor impairments
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.
Interventions
DEVICEAir splints
Application of CPPS (Urias splints) + physiotherapy
Sponsors
Hospital Beata María Ana
Alfonso X El Sabio University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper limb sensorimotor function measured by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in trunk function measured by the Trunk Control Test (TCT) | 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. |
| Change in balance performance measured by the Mini-Balance Evaluation Systems Test (Mini-BESTest) | 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. |
| Change in hand strength (flexion and extension) measured using the AMADEO robotic system. | 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. |
| Change in range of motion (ROM) of the shoulder and fingers 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. ROM will be recorded in degrees (°). Higher values indicate better joint mobility. |
Countries
Spain
Outcome results
None listed