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The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Comparison of the Effectiveness of Two Different Types of Slings in Shoulder Subluxation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04830189
Enrollment
32
Registered
2021-04-05
Start date
2018-01-10
Completion date
2019-01-01
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Rehabilitation

Keywords

Stroke, subluxation, shoulder, slings

Brief summary

The aim of this study is to investigate the effectiveness of shoulder slings on pain, motor function, daily life and balance in acute hemiplegic patients and to investigate whether different types of slings are superior to each other.

Detailed description

Thirty-two patients with hemiplegic shoulder subluxation due to acute stroke were divided into two groups: shoulder supported slings and forearm supported slings. Hemiplegia rehabilitation passive and active-assistive range of motion, stretching, and neurophysiologic exercises were performed for all patients per day for 8 weeks.Pain assessment was performed with Visual Analog Scale, sensorimotor evaluation was performed with Fugl Meyer Assessment of Motor Function,daily life activities were assessed with Barthel Index, and balance was evaluated with Berg Balance Scale.

Interventions

Patients were used shoulder slings

DEVICEforearm sling

Patients were used forearm slings

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Patients were assigned to two groups, shoulder supported slings (group 1, n = 20) and forearm supported slings (group 2, n = 20), by an investigator who was blinded to the study via randomization created by a computer software. Evaluation of the detailed physical examination results, evaluation of demographic features such as age, gender, and etiology as well as evaluation of treatment results were performed by the physiatrist who was blind to randomization.

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Acute patients who were independent and ambulatory prior to stroke and had their first stroke attack (\<3 months) * Mini-mental Status Test (MMST) score ≥ 24, * Developing hemiplegia after stroke, standing independently for at least 2 minutes, * Lower limb being in stage 4-5 according to the Brunnstrom Approach (for ambulation and standard balance) * Upper limb being in stage 1-2 according to the Brunnstrom Approach * Spasticity 0-1+ according to Modified Ashworth scale

Exclusion criteria

* Has a neurological history other than the diagnosis of hemiplegia (Parkinson's etc.) * Having used shoulder slings and orthosis. * Having a disease that can affect balance (cranial, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale (VAS)Change from Baseline VAS score at 8 weeksPain assessment was performed with Visual Analog Scale after 8-weeks after treatment. Using a ruler, the score is determined by measuring the distance (mm) on the 100-mm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Fugl-Meyer Assessment of Motor Recovery after StrokeChange from Baseline Fugl Meyer test score at 8 weeksSensorimotor evaluation was performed with Fugl-Meyer Assessment of Motor Recovery after Stroke. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Barthel IndexChange from Baseline Barthel Index score at 8 weeksDaily life activities were assessed with Barthel Index. The minimum score is 0, which indicates complete dependency and, the maximum score is 100 indicates complete independence.
Berg Balance Scale (BBS)Change from Baseline Berg Balance Scale score at 8 weeksBalance was evaluated with Berg Balance Scale. The minimum score is 0 and, the maximum score is 56. 0-20 on the BBS represents balance impairment; 21-40 on the BBS represents acceptable balance; 41-56 on the BBS represents good balance.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026