Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shoulder Sling, No Sling.
- Who it may be relevant to
- Registry conditions: Hemiplegia, Balance Disorders, Mobility Limitation, Shoulder Subluxation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Cross-Over Study on the Effect of Shoulder Sling Use on Balance and Functional Mobility in Patients With Hemiplegia During the Subacute Phase of Stroke Rehabilitation
Overview
This study examines whether wearing a shoulder sling can improve balance and mobility in people who are recovering from a stroke. Participants will perform simple movement and balance tests twice-once with the sling and once without. The goal is to find out if using the sling helps patients feel more stable and safe during walking and everyday activities.
Detailed description
This is a cross-over study designed to evaluate the impact of shoulder sling use on balance and functional mobility in patients recovering from stroke in the subacute phase. Participants will be asked to complete three validated functional tests: the Timed Up and Go (TUG) test, the Functional Reach Test (FRT), and the Modified Four Square Step Test (mFSST). Each test will be performed twice, once with the shoulder sling and once without, in randomized order. The study aims to determine whether the sling provides measurable benefits in stability and performance during movement tasks. Data will be collected in rehabilitation centers under the supervision of clinical researchers.
Interventions
- Device Shoulder Sling
Use of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing. - Other No Sling
Functional mobility tests performed without the use of any assistive shoulder device.
Primary outcome measures
- Timed Up and Go (TUG) Test [Time frame: Within 1 day (each participant performs it twice - with and without sling)]
- Functional Reach Test (FRT) [Time frame: Within 1 day (each participant performs it twice - with and without sling)]
- Modified Four Square Step Test (mFSST) [Time frame: Within 1 day (each participant performs it twice - with and without sling)]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset)
- Hemiplegia affecting one upper limb
- Brunnstrom stage < 4 for the affected upper limb
- Functional Ambulation Category (FAC) score > 3
- Age between 40 and 80 years
- Ability to follow simple instructions
- Medically stable to participate in balance and mobility testing
- Signed informed consent
Exclusion criteria
- Severe cognitive impairment (e.g. MMSE < 23)
- Visual or vestibular disorders affecting balance
- Significant orthopedic or musculoskeletal conditions of the lower limbs
- Uncontrolled cardiovascular or pulmonary disease
- Use of assistive devices that prevent sling application
- Severe aphasia interfering with understanding or communication
- Skin lesions or injuries at the shoulder region preventing sling use
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Greece · 1 center
- Filoktitis Recovery and Rehabilitation Center — Koropí
Identifiers
NCT: NCT06904768 · SLS2025-GR01