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Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06904768
Acronym
SLS-Stroke
Enrollment
17
Registered
2025-04-01
Start date
2025-03-13
Completion date
2025-04-30
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Disorders, Hemiplegia, Mobility Limitation, Shoulder Subluxation, Stroke

Keywords

Stroke, Hemiplegia, mobility, dynamic balance, balance, shoulder brace, arm sling

Brief summary

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

Use of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing.

Functional mobility tests performed without the use of any assistive shoulder device.

Sponsors

University of West Attica
CollaboratorOTHER
Arnaoutis Stylianos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Timed Up and Go (TUG) TestWithin 1 day (each participant performs it twice - with and without sling)Time required (in seconds) to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Functional Reach Test (FRT)Within 1 day (each participant performs it twice - with and without sling)Distance reached (in centimeters) while standing and reaching forward without losing balance.
Modified Four Square Step Test (mFSST)Within 1 day (each participant performs it twice - with and without sling)Time required to step in all four quadrants in a specified sequence.

Countries

Greece

Contacts

Primary ContactStylianos Arnaoutis
mscphys23001@uniwa.gr+306981199528
Backup ContactStylianos Arnaoutis
mscphys23001@uniwa.gr6981199528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026