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RecruitingNCT06904768SLS-StrokeUpdated Apr 1, 2025

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

An interventional study of Shoulder Sling and No Sling in Hemiplegia, Balance Disorders and Mobility Limitation, sponsored by Arnaoutis Stylianos. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Arnaoutis Stylianos · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Stroke
  • Hemiplegia
  • mobility
  • dynamic balance
  • balance
  • shoulder brace
  • arm sling
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 17 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Arnaoutis Stylianos as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (estimated)

Study arms

  • 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

  • Active comparator
    No Sling

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

    Other: No Sling

Interventions

  • DeviceShoulder Sling

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

  • OtherNo Sling

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 1 day (each participant performs it twice - with and without sling)

  2. Functional Reach Test (FRT)

    Distance reached (in centimeters) while standing and reaching forward without losing balance.

    Time frame: Within 1 day (each participant performs it twice - with and without sling)

  3. Modified Four Square Step Test (mFSST)

    Time required to step in all four quadrants in a specified sequence.

    Time frame: Within 1 day (each participant performs it twice - with and without sling)

07

Study locations

1 of 1 sites recruiting
  • Filoktitis Recovery and Rehabilitation Center
    Koropi, Attica 19441, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06904768
Lead sponsor
Arnaoutis Stylianos
Collaborators
University of West Attica
Responsible party
Arnaoutis Stylianos (Principal Investigator, University of West Attica) — Sponsor-investigator
First posted
Apr 1, 2025
Start date
Mar 13, 2025
Primary completion
Apr 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Apr 1, 2025

Study contacts

Stylianos Arnaoutis
Contact
mscphys23001@uniwa.gr
+306981199528
Stylianos Arnaoutis
Contact
mscphys23001@uniwa.gr
6981199528
Nikolaos Chrysagis
study chair · University of West Attica

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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