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NCT Number: NCT06904768

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder Sling

Device

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

No Sling

Other

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

Primary outcomes

  1. Timed Up and Go (TUG) Test

    Time frame: Within 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.

  2. Functional Reach Test (FRT)

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

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

  3. Modified Four Square Step Test (mFSST)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stylianos Arnaoutis

CONTACT

[email protected]

+306981199528

Stylianos Arnaoutis

CONTACT

[email protected]

6981199528

Sponsors and collaborators

Lead sponsor

Arnaoutis Stylianos

Other

Collaborators

  • University of West Attica

Registry information

Official study 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

Acronym: SLS-Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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