The Effectiveness of Two Different Types of Shoulder Slings in Stroke

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemiplegia, Rehabilitation

Intervention / Treatment
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* Device: shoulder sling
* Device: forearm sling


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shoulder slings<br>Patients were used shoulder sling in addition to conservative treatment. | Device: shoulder sling<br>* Patients were used shoulder slings<br>|
| Active Comparator: forearm sling<br>Patients were used forearm sling in addition to conservative treatment. | Device: forearm sling<br>* Patients were used forearm slings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Pain 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. | Change from Baseline VAS score at 8 weeks | 
| Fugl-Meyer Assessment of Motor Recovery after Stroke | Sensorimotor 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. | Change from Baseline Fugl Meyer test score at 8 weeks | 
| Barthel Index | Daily 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. | Change from Baseline Barthel Index score at 8 weeks | 
| Berg Balance Scale (BBS) | Balance 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. | Change from Baseline Berg Balance Scale score at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, subluxation, shoulder, slings