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Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications (EO31)

Primary Purpose

Cerebrovascular Accident

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluate the effects of the EO31 shoulder sling in adults post-stoke
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Cerebrovascular Accident, sling, Upper limb impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

the EO31 shoulder sling

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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).
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).
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Spasticity with TARDIEU scale
Evaluate 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 sling
Evaluate if patient use the sling : number of use by day
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.
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)
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)
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)
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)
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)

Full Information

First Posted
July 11, 2019
Last Updated
November 6, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04028999
Brief Title
Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Acronym
EO31
Official Title
Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Cerebrovascular Accident, sling, Upper limb impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the EO31 shoulder sling
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Evaluate the effects of the EO31 shoulder sling in adults post-stoke
Intervention Description
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 Outcome Measure Information:
Title
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale
Description
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).
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)
Description
The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain)
Time Frame
24 hours
Title
Evaluate shoulder pain with EVA scale
Description
The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).
Time Frame
5 weeks
Title
Evaluate shoulder pain with EVA scale
Description
The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).
Time Frame
baseline
Title
Spasticity with TARDIEU scale
Description
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Time Frame
baseline
Title
Spasticity with TARDIEU scale
Description
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Time Frame
7 days
Title
Spasticity with TARDIEU scale
Description
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Time Frame
14 days
Title
Spasticity with TARDIEU scale
Description
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Time Frame
5 weeks
Title
Number of daily use of the upper limb sling
Description
Evaluate if patient use the sling : number of use by day
Time Frame
5 weeks
Title
Clinical measure of appendage
Description
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Time Frame
baseline
Title
Clinical measure of appendage
Description
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Time Frame
7 days
Title
Clinical measure of appendage
Description
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Time Frame
14 days
Title
Clinical measure of appendage
Description
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.
Time Frame
5 weeks
Title
motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale
Description
the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
Time Frame
baseline
Title
motor function of upper limb with CAHAI scale
Description
the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
Time Frame
7 days
Title
motor function of upper limb with CAHAI scale
Description
the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)
Time Frame
5 weeks
Title
questionnaire for quality of patient's life
Description
the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)
Time Frame
baseline
Title
questionnaire for quality of patient's life
Description
the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evelyne Castel-Lacanal, MD
Phone
33-5 61 32 21 20
Email
castel-lacanal.e@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Evelyne Castel-Lacanal, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne Castel-Lacanal, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magalie Martin
Email
martin.m@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Evelyne Castel-Lacanal, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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