Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale
Study Overview
Brief Summary
Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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) >
- •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.
Arms & Interventions
the EO31 shoulder sling
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.
Intervention: Evaluate the effects of the EO31 shoulder sling in adults post-stoke (Device)
Outcomes
Primary Outcomes
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale
Time Frame: 5 weeks
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).
Secondary Outcomes
- motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale(baseline)
- Number of daily use of the upper limb sling(5 weeks)
- motor function of upper limb with CAHAI scale(5 weeks)
- Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)(24 hours)
- Evaluate shoulder pain with EVA scale(baseline)
- questionnaire for quality of patient's life(5 weeks)
- Spasticity with TARDIEU scale(5 weeks)
- Clinical measure of appendage(5 weeks)
- Evaluate shoulder pain with EVA scale(5 weeks)
- Spasticity with TARDIEU scale(baseline)
- Spasticity with TARDIEU scale(7 days)
- Spasticity with TARDIEU scale(14 days)
- Clinical measure of appendage(baseline)
- Clinical measure of appendage(7 days)
- Clinical measure of appendage(14 days)
- motor function of upper limb with CAHAI scale(7 days)
- questionnaire for quality of patient's life(baseline)