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Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient (ERIAMS)

Primary Purpose

Hemiplegia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shoulder mobilisation
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiplegia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
  • Having made a cerebrovascular accident between 30 and 3 days before inclusion
  • with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm
  • able to understand the question: "Do you have arm pain?"

Exclusion Criteria:

  • with visual analogue scale score lower than 20 mm at the inclusion
  • with aphasia of comprehension
  • with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
  • opposing to any mobilization
  • with shoulder pathology previously known
  • history of cerebrovascular accident prior 30 days before inclusion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Shoulder mobilisation

    Arm Description

    The shoulder mobilisation is performed daily by a physiotherapist for 45 days.

    Outcomes

    Primary Outcome Measures

    Pain evaluation with visual analogic scale
    Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45

    Secondary Outcome Measures

    Full Information

    First Posted
    September 8, 2016
    Last Updated
    November 22, 2019
    Sponsor
    Centre Hospitalier Universitaire de la Réunion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02904148
    Brief Title
    Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient
    Acronym
    ERIAMS
    Official Title
    Measurement of the Analgesic Efficacy of Shoulder Mobilization in Hemiplegic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de la Réunion

    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
    Hemiplegia is a high prevalence pathology with 1 per 1000 habitants in France. One of these complications is shoulder pain which affects about 35 to 70% of cases. The medical care of this complication is critical because it affects the patient's quality of life and also hinders participation in rehabilitation sessions slowing the recovery of independence in activities of daily living. Literature confirmed the involvement of the scapula in the hemiplegic shoulder pain with his attitude pronounced lateral rotation. But no data to confirm that passive mobilization reduce shoulder pain. Because no data available to permit us to determine the sample size we set-up this preliminary study to check if efficiency found in these preliminary data are consistent with an estimable real efficacy in a randomized trial feasible.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Shoulder mobilisation
    Arm Type
    Experimental
    Arm Description
    The shoulder mobilisation is performed daily by a physiotherapist for 45 days.
    Intervention Type
    Procedure
    Intervention Name(s)
    Shoulder mobilisation
    Intervention Description
    early shoulder mobilisation
    Primary Outcome Measure Information:
    Title
    Pain evaluation with visual analogic scale
    Description
    Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45
    Time Frame
    Change of pain evaluation between Day 0 and Day 45

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon) Having made a cerebrovascular accident between 30 and 3 days before inclusion with pain in the upper limb whose score with visual analogue scale is greater than or equal to 20 mm able to understand the question: "Do you have arm pain?" Exclusion Criteria: with visual analogue scale score lower than 20 mm at the inclusion with aphasia of comprehension with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...) opposing to any mobilization with shoulder pathology previously known history of cerebrovascular accident prior 30 days before inclusion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andre Muller, MD
    Organizational Affiliation
    CHU de La Réunion
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

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