Clinical trial NCT06904768: Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Balance Disorders
Mobility Limitation
Shoulder Subluxation
Stroke
Keywords: Stroke
Hemiplegia
mobility
dynamic balance
balance
shoulder brace
arm sling
Lead sponsor: University of West Attica
Sponsor class: OTHER
Collaborators: name: University of West Attica
First posted: 2025-04-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Timed Up and Go (TUG) Test
timeFrame: Within 1 day (each participant performs it twice - with and without sling)
measure: Functional Reach Test (FRT)
timeFrame: Within 1 day (each participant performs it twice - with and without sling)
measure: Modified Four Square Step Test (mFSST)
timeFrame: Within 1 day (each participant performs it twice - with and without sling)
Secondary outcomes:
Other outcomes:
Locations:
city: Koropi
country: Greece
facility: Filoktitis Recovery and Rehabilitation Center
state: Attica
Study officials:
affiliation: University of West Attica
name: Nikolaos Chrysagis
role: STUDY_CHAIR
References: