Cerebrovascular AccidentEO31NCT04028999
Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
A study testing Evaluate the effects of the EO31 shoulder sling in adults post-stoke in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Evaluate the effects of the EO31 shoulder sling in adults post-stoke
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.
Read the 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
- Conditions
- Cerebrovascular Accident
- Being tested
- Evaluate the effects of the EO31 shoulder sling in adults post-stoke
- Keywords
- Cerebrovascular Accident, sling, Upper limb impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the effects of the EO31 shoulder sling in adults post-stokeDevice
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 group | Role | What they receive |
|---|---|---|
| the EO31 shoulder sling | Experimental | 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. Receives: Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks
Secondary outcomes (17)
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)
Measured: 24 hours
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).
Measured: 5 weeks
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).
Measured: baseline
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Measured: baseline
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Measured: 7 days
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Measured: 14 days
Spasticity with TARDIEU scale
Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured
Measured: 5 weeks
Number of daily use of the upper limb sling
Evaluate if patient use the sling : number of use by day
Measured: 5 weeks
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Measured: baseline
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Measured: 7 days
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter
Measured: 14 days
Clinical measure of appendage
Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.
Measured: 5 weeks
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)
Measured: baseline
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)
Measured: 7 days
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)
Measured: 5 weeks
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)
Measured: baseline
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)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start3 Jul 2019
- Primary completion11 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyne Castel-Lacanal, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028999
- Sponsor's protocol ID
- RC31/17/0460
- Acronym
- EO31
- Status last verified
- Sep 2025
- First submitted
- 11 Jul 2019
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montane E, Pradie M, Bigarre I, Lebely C, Lelievre A, Cormier C, Butterworth J, Lepage B, Marque P, de Boissezon X, Castel-Lacanal E. A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study. Ann Phys Rehabil Med. 2025 Oct;68(7):102014. doi: 10.1016/j.rehab.2025.102014. Epub 2025 Aug 21.
PubMed 40845630
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
- ClinicalTrials.gov ID
- NCT04028999
- Acronym / sponsor ID
- EO31 / RC31/17/0460
- Conditions
- Cerebrovascular Accident
- Keywords
- Cerebrovascular Accident, sling, Upper limb impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the EO31 shoulder sling | Experimental | Device: Evaluate the effects of the EO31 shoulder sling in adults post-stokeTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluate the effects of the EO31 shoulder sling in adults post-stokeInvestigator 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 | Device | the EO31 shoulder sling |
Primary outcome
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).
17 secondary outcomes
Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)
Time frame: 24 hours
Evaluate shoulder pain with EVA scale
Time frame: 5 weeks
Evaluate shoulder pain with EVA scale
Time frame: baseline
Spasticity with TARDIEU scale
Time frame: baseline
Spasticity with TARDIEU scale
Time frame: 7 days
Spasticity with TARDIEU scale
Time frame: 14 days
Spasticity with TARDIEU scale
Time frame: 5 weeks
Number of daily use of the upper limb sling
Time frame: 5 weeks
Clinical measure of appendage
Time frame: baseline
Clinical measure of appendage
Time frame: 7 days
Clinical measure of appendage
Time frame: 14 days
Clinical measure of appendage
Time frame: 5 weeks
motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale
Time frame: baseline
motor function of upper limb with CAHAI scale
Time frame: 7 days
motor function of upper limb with CAHAI scale
Time frame: 5 weeks
questionnaire for quality of patient's life
Time frame: baseline
questionnaire for quality of patient's life
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 40845630Montane E, Pradie M, Bigarre I, Lebely C, Lelievre A, Cormier C, Butterworth J, Lepage B, Marque P, de Boissezon X, Castel-Lacanal E. A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study. Ann Phys Rehabil Med. 2025 Oct;68(7):102014. doi: 10.1016/j.rehab.2025.102014. Epub 2025 Aug 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyne Castel-Lacanal, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the effects of the EO31 shoulder sling in adults post-stoke in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04028999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.