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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028999
Acronym
EO31
Enrollment
25
Registered
2019-07-23
Start date
2019-07-03
Completion date
2023-09-01
Last updated
2025-09-08

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

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular Accident, sling, Upper limb impairment

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

Interventions

DEVICEEvaluate the effects of the EO31 shoulder sling in adults post-stoke

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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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) \> 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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale5 weeksGAS (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

MeasureTime frameDescription
Evaluate shoulder pain with EVA scale5 weeksThe shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).
Spasticity with TARDIEU scalebaselineEvaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Number of daily use of the upper limb sling5 weeksEvaluate if patient use the sling : number of use by day
Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)24 hoursThe shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain)
motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scalebaselinethe motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
motor function of upper limb with CAHAI scale7 daysthe motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
questionnaire for quality of patient's lifebaselinethe quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)
Clinical measure of appendagebaselineEvaluate of appendage with clinical measure during all the treatment. This measure is in millimeter

Countries

France

Outcome results

None listed

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