Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

Not Applicable

Withdrawn

• Conditions: Hemiplegia
• Interventions: Procedure: Shoulder mobilisation

• Registration Number: NCT02904148
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26
• Study Start: 2020-01
• Primary Completion: 2022-04
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shoulder mobilisation	Shoulder mobilisation	The shoulder mobilisation is performed daily by a physiotherapist for 45 days.

Primary Outcome Measures

Name	Time	Method
Pain evaluation with visual analogic scale	Change of pain evaluation between Day 0 and Day 45	Proportion of patients reducing by at least 20 mm their score on the visual analogic scale (VAS) from baseline Day 45