Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06904768

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

Led by Arnaoutis Stylianos · Updated on 2025-04-01

17

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Arnaoutis Stylianos

Lead Sponsor

U

University of West Attica

Collaborating Sponsor

AI-Summary

What this Trial Is About

The research investigates whether wearing a shoulder sling improves balance and mobility in people recovering from stroke during the subacute phase. It focuses on patients with hemiplegia affecting one upper limb and aims to understand if using the sling helps patients feel more stable and safe while walking and performing everyday activities. This cross-over study evaluates the effect of the sling on balance and functional mobility using validated movement tests. Participants will complete three functional tests: the Timed Up and Go (TUG), Functional Reach Test (FRT), and Modified Four Square Step Test (mFSST). Each test is performed twice, once while wearing a shoulder sling on the affected upper limb and once without the sling, with the order randomized. The study is conducted in rehabilitation centers under clinical researcher supervision to assess measurable benefits of the sling. During the study, participants perform these balance and mobility tests under controlled conditions. Researchers measure performance on the tests with and without the sling on the same day. The primary outcomes focus on comparing results from both conditions to evaluate stability and functional mobility. Participants must be medically stable, able to follow instructions, and attend testing sessions, which last about one day per participant.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of stroke in the subacute phase (up to 6 months post-onset)
  • Hemiplegia affecting one upper limb
  • Brunnstrom stage less than 4 for the affected upper limb
  • Functional Ambulation Category (FAC) score greater than 3
  • Age between 40 and 80 years
  • Ability to follow simple instructions
  • Medically stable to participate in balance and mobility testing
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment (e.g. MMSE less than 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants perform balance and mobility tests with and without the shoulder sling to evaluate its effect on functional mobility and stability.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Filoktitis Recovery and Rehabilitation Center

Koropí, Attica, Greece, 19441

Actively Recruiting

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Research Team

S

Stylianos Arnaoutis

S

Stylianos Arnaoutis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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