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

NCT06904768 | Recruiting

• 1 other identifier: SLS2025-GR01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Shoulder Sling

EXPERIMENTAL

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

Device: Shoulder Sling

No Sling

ACTIVE COMPARATOR

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

Other: No Sling

Interventions

Shoulder Sling DEVICE

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

Shoulder Sling

No Sling OTHER

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

No Sling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arnaoutis Stylianos: lead
• University of West Attica: collaborator

Study Sites (1)

Filoktitis Recovery and Rehabilitation Center

Koropí, Attica, 19441, Greece

RECRUITING

MeSH Terms

Conditions

Hemiplegia; Mobility Limitation; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nikolaos Chrysagis

  University of West Attica

  STUDY CHAIR

Central Study Contacts

Stylianos Arnaoutis

CONTACT

+306981199528; mscphys23001@uniwa.gr

Stylianos Arnaoutis

CONTACT

6981199528; mscphys23001@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 1, 2025
• Study Start: March 13, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)