Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

Study Overview
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Brief Summary
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Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

Detailed Description
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Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Pain associated with UL impairment due to multifactorial causes is a frequent symptom in patients with stroke. Occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (SD) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. At present, positioning principles of the hemiplegic shoulder exist in clinical practice. These are aimed at prevention of pain associated with UL Impairment; however there is no clear consensus among professionals of particular SD that should be implemented for adults with stroke

Official Title
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Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having suffered in the last 6 months maximum a first stroke responsible for hemiplegia. Finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf. Boston Diagnostic Aphasia Examination (BDAE) > 3. Consent of the patient Patient affiliated or benefiting from a social security scheme Exclusion Criteria: Stroke recurrence, or stroke more than 6 months-old Patient already wearing a coaptation scarf Presence of lymphoedema, venous thrombosis of the upper limb Neoprene allergy Severe cognitive impairment: Mini-Mental State (MMS) <15 Patient being part of another care protocol Adult under the protection of justice, tutors or curators Pregnant or lactating woman.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the EO31 shoulder sling<br>To develop and evaluate the effects of the EO31 shoulder sling for the prevention of pain, subluxation, spasticity, as well as effect on increasing functional use of the UL in activities of daily living. | Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke<br>* Investigator want to evaluate the efficient of the EO31 shoulder sling in adults post-stroke. The EO31 shoulder sling is made-to-measure shoulder pads for upper limb after cerebrovascular accident<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale | GAS (Goal Attainment Scale) scores will be described with regards to the 3 client-centred objectives. The score for each objective is comprised between -2 (when objective is not achieve) to 2 (achieve objective). | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale) | The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain) | 24 hours | 
| Evaluate shoulder pain with EVA scale | The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain). | 5 weeks | 
| Evaluate shoulder pain with EVA scale | The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain). | baseline | 
| Spasticity with TARDIEU scale | Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured | baseline | 
| Spasticity with TARDIEU scale | Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured | 7 days | 
| Spasticity with TARDIEU scale | Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured | 14 days | 
| Spasticity with TARDIEU scale | Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured | 5 weeks | 
| Number of daily use of the upper limb sling | Evaluate if patient use the sling : number of use by day | 5 weeks | 
| Clinical measure of appendage | Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter | baseline | 
| Clinical measure of appendage | Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter | 7 days | 
| Clinical measure of appendage | Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter | 14 days | 
| Clinical measure of appendage | Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter. | 5 weeks | 
| motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale | the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong) | baseline | 
| motor function of upper limb with CAHAI scale | the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong) | 7 days | 
| motor function of upper limb with CAHAI scale | the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong) | 5 weeks | 
| questionnaire for quality of patient's life | the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life) | baseline | 
| questionnaire for quality of patient's life | the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life) | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Accident, sling, Upper limb impairment