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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-13

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemiplegia Balance Disorders Mobility Limitation Shoulder Subluxation Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Shoulder Sling

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

Group Type EXPERIMENTAL

Shoulder Sling

Intervention Type DEVICE

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

No Sling

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

Group Type ACTIVE_COMPARATOR

No Sling

Intervention Type OTHER

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

Interventions

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Shoulder Sling

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

Intervention Type DEVICE

No Sling

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No