HemiplegiaSLS-StrokeNCT06904768
Effect of Shoulder Sling Use on Balance and Mobility in Subacute Stroke Patients
A study testing Shoulder Sling and No Sling in people with Hemiplegia and Balance Disorders, run by Arnaoutis Stylianos at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Balance Disorders, Mobility Limitation
- What is being tested?
- Shoulder Sling and No Sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteGreece
- Study dates
- 13 Mar 2025to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Filoktitis Recovery and Rehabilitation Center
Koropí, Attica, 19441
Eythimia Vagena, 6948467145, e.vagena@filorehab.gr
Stylianos Arnaoytis, 6981199528, mscphys23001@uniwa.gr
About this study
Official 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
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.
- Conditions
- Hemiplegia, Balance Disorders, Mobility Limitation, Shoulder Subluxation, Stroke
- Being tested
- Shoulder Sling, No Sling
- Keywords
- Stroke, Hemiplegia, mobility, dynamic balance, balance, shoulder brace, arm sling
- Medical subject headings
- Hemiplegia, Mobility Limitation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder SlingDevice
Use of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing.
No SlingOther
Functional mobility tests performed without the use of any assistive shoulder device.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Sling | Experimental | Participants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb. Receives: Device: Shoulder Sling |
| No Sling | Active comparator | The same functional tests are performed without the use of a shoulder sling. Receives: Other: No Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Within 1 day (each participant performs it twice - with and without sling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Mar 2025
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arnaoutis Stylianos
- Sponsor type
- University, hospital or other
- Collaborators
- University of West Attica
- Responsible party
- Sponsor-investigator, Arnaoutis Stylianos, University of West Attica
- Investigators
- Nikolaos Chrysagis, Study chair, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904768
- Sponsor's protocol ID
- SLS2025-GR01
- Acronym
- SLS-Stroke
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06904768
- Acronym / sponsor ID
- SLS-Stroke / SLS2025-GR01
- Conditions
- Hemiplegia, Balance Disorders, Mobility Limitation, Shoulder Subluxation, Stroke
- Keywords
- Stroke, Hemiplegia, mobility, dynamic balance, balance, shoulder brace, arm sling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Arnaoutis StylianosUniversity, hospital or other
- Collaborators
- University of West Attica
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Sling | Experimental | Device: Shoulder SlingParticipants perform balance and mobility tests (TUG, FRT, mFSST) while wearing a shoulder sling on the affected upper limb. |
| No Sling | Active comparator | Other: No SlingThe same functional tests are performed without the use of a shoulder sling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder SlingUse of a shoulder sling (Reh4mat AM-SOB) on the affected upper limb during mobility and balance testing. | Device | Shoulder Sling |
| No SlingFunctional mobility tests performed without the use of any assistive shoulder device. | Other | No Sling |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaos Chrysagis study chair
University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Sling and No Sling in people with Hemiplegia and Balance Disorders, run by Arnaoutis Stylianos at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stylianos Arnaoutis (+306981199528, mscphys23001@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Test (time frame: Within 1 day (each participant performs it twice - with and without sling)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.