Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

NCT ID: NCT02904148

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemiplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Shoulder mobilisation

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

Group Type EXPERIMENTAL

Shoulder mobilisation

Intervention Type PROCEDURE

early shoulder mobilisation

Interventions

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Shoulder mobilisation

early shoulder mobilisation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andre Muller, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Other Identifiers

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2015/CHU/09

Identifier Type: -

Identifier Source: org_study_id

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