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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiplegia; Mobility Limitation; Balance Disorders; Shoulder Subluxation
• Intervention / Treatment: Device: Shoulder Sling; Other: No Sling

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.

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stylianos Arnaoutis; Phone Number: +306981199528; Email: mscphys23001@uniwa.gr
• Study Contact Backup: Name: Stylianos Arnaoutis; Phone Number: 6981199528; Email: mscphys23001@uniwa.gr

Study Locations

• Greece
  • Attica
    • Koropi, Attica, Greece, 19441
      • Recruiting
      • Filoktitis Recovery and Rehabilitation Center
      • Contact: Eythimia Vagena; Phone Number: 6948467145; Email: e.vagena@filorehab.gr
      • Contact: Stylianos Arnaoytis; Phone Number: 6981199528; Email: mscphys23001@uniwa.gr
      • Contact: Efthimia Vagena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shoulder Sling; Participants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb.	Device: Shoulder Sling; Use of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing.
Active Comparator: No Sling; The same functional tests are performed without the use of a shoulder sling.	Other: No Sling; Functional mobility tests performed without the use of any assistive shoulder device.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arnaoutis Stylianos
• Collaborators: University of West Attica
• Investigators: Study Chair: Nikolaos Chrysagis, University of West Attica

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; mobility; balance; dynamic balance; Hemiplegia; arm sling; shoulder brace
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Stroke; Mobility Limitation; Hemiplegia
• Other Study ID Numbers: SLS2025-GR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No