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Clinical Trials/NCT04028999
NCT04028999CompletedNot Applicable

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

University Hospital, Toulouse2 sites in 1 country25 target enrollmentStarted: July 3, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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) >
  • 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.

Outcomes

Primary Outcomes

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

  • Clinical measure of appendage(5 weeks)
  • Number of daily use of the upper limb sling(5 weeks)
  • motor function of upper limb with CAHAI scale(5 weeks)
  • Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)(24 hours)
  • Evaluate shoulder pain with EVA scale(baseline)
  • motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale(baseline)
  • questionnaire for quality of patient's life(5 weeks)
  • Spasticity with TARDIEU scale(5 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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