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Completed

NCT Number: NCT04028999

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

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

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse

Toulouse, 31000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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

  1. Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)

    Time frame: 24 hours

    The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain)

  2. Evaluate shoulder pain with EVA scale

    Time frame: 5 weeks

    The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).

  3. Evaluate shoulder pain with EVA scale

    Time frame: baseline

    The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).

  4. Spasticity with TARDIEU scale

    Time frame: baseline

    Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured

  5. Spasticity with TARDIEU scale

    Time frame: 7 days

    Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured

  6. Spasticity with TARDIEU scale

    Time frame: 14 days

    Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured

  7. Spasticity with TARDIEU scale

    Time frame: 5 weeks

    Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured

  8. Number of daily use of the upper limb sling

    Time frame: 5 weeks

    Evaluate if patient use the sling : number of use by day

  9. Clinical measure of appendage

    Time frame: baseline

    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter

  10. Clinical measure of appendage

    Time frame: 7 days

    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter

  11. Clinical measure of appendage

    Time frame: 14 days

    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter

  12. Clinical measure of appendage

    Time frame: 5 weeks

    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.

  13. motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale

    Time frame: baseline

    the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)

  14. motor function of upper limb with CAHAI scale

    Time frame: 7 days

    the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)

  15. motor function of upper limb with CAHAI scale

    Time frame: 5 weeks

    the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)

  16. questionnaire for quality of patient's life

    Time frame: baseline

    the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)

  17. questionnaire for quality of patient's life

    Time frame: 5 weeks

    the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: EO31

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2019
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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