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Withdrawn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
About this trial
This is an interventional supportive care trial for Hemiplegia
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
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
NCT ID
NCT02904148
First Posted
September 8, 2016
Last Updated
November 22, 2019
Sponsor
Centre Hospitalier Universitaire de la Réunion
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Withdrawn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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