Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients (SLS-Stroke)

Arnaoutis Stylianos

Status: Enrolling

Conditions: Stroke; Balance Disorders; Mobility Limitation; Hemiplegia; Shoulder Subluxation

Treatments: Other: No Sling; Device: Shoulder Sling

Study type: Interventional

Funder types: Other

Identifiers

NCT06904768

SLS2025-GR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Shoulder Sling

Experimental group

Description:

Participants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb.

Treatment:

Device: Shoulder Sling

No Sling

Active Comparator group

Description:

The same functional tests are performed without the use of a shoulder sling.

Treatment:

Other: No Sling