Passive Mobilisation of Region of Shoulder Joints for Hemiplegic Patient

NCT02904148 | Withdrawn

• 1 other identifier: 2015/CHU/09
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

• 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

  Change of pain evaluation between Day 0 and Day 45

Study Arms (1)

Shoulder mobilisation

EXPERIMENTAL

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

Procedure: Shoulder mobilisation

Interventions

Shoulder mobilisation PROCEDURE

early shoulder mobilisation

Shoulder mobilisation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in Physical Medicine and Rehabilitation at Centre Hospitalier Universitaire Réunion (Site of Le Tampon)
• 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?"

You may not qualify if:

• with aphasia of comprehension
• with medical contraindication for passive shoulder mobilisation (Shoulder fracture, dislocation,...)
• opposing to any mobilization
• with shoulder pathology previously known

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andre Muller, MD

  CHU de La Réunion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: January 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 26, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share