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出境医 / 临床实验 / Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications (EO31)

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

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Device: Evaluate 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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Evelyne Castel-Lacanal, MD 33-5 61 32 21 20 castel-lacanal.e@chu-toulouse.fr
Contact: Evelyne Castel-Lacanal, MD

Locations
Layout table for location information
France
CHU de Toulouse Recruiting
Toulouse, France, 31000
Contact: Magalie Martin       martin.m@chu-toulouse.fr   
Principal Investigator: Evelyne Castel-Lacanal, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Evelyne Castel-Lacanal, MD University Hospital, Toulouse
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 23, 2019
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE July 3, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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)
  • 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).
  • 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).
  • 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
  • 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
  • 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
  • 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
  • Number of daily use of the upper limb sling [ Time Frame: 5 weeks ]
    Evaluate if patient use the sling : number of use by day
  • Clinical measure of appendage [ Time Frame: baseline ]
    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
  • Clinical measure of appendage [ Time Frame: 7 days ]
    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
  • Clinical measure of appendage [ Time Frame: 14 days ]
    Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
  • Clinical measure of appendage [ Time Frame: 5 weeks ]
    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 [ 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Official Title  ICMJE Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebrovascular Accident
Intervention  ICMJE Device: Evaluate 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
Study Arms  ICMJE Experimental: 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: Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019) 		25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Evelyne Castel-Lacanal, MD 33-5 61 32 21 20 castel-lacanal.e@chu-toulouse.fr
Contact: Evelyne Castel-Lacanal, MD
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028999
Other Study ID Numbers  ICMJE RC31/17/0460
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evelyne Castel-Lacanal, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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