Multi-disciplinary Prevention Program

NCT02563431 | Completed

• 1 other identifier: CHUBX 2011/17
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This common occurrence is a cause for concern in the rehabilitation setting as it leads to impairment of functional outcomes induced by discomfort and delays in rehabilitation, important psycho-emotional repercussions as there is a correlation between upper arm pain and depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can ultimately give rise to type 1 "complex regional pain syndrome" (CRPS I). There is no consensus on treatment, care pathways or useful devices for positioning acute stroke patients in the literature. Our objective is to compare the effectiveness of a new positioning procedure of the hemiplegic arm with conventional positioning (pillow and "shoulder-immobilisation" sling) in acute stroke patients. Patient's actions are focus in 4 points:

• Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction)
• Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
• A training of the patient and members of family on pathology, risk, use of material
• Daily passive mobilisation of the upper member by a therapist.

Conditions

Stroke

Keywords

shoulder pain; prevention program

Outcome Measures

Primary Outcomes (1)

• Change from baseline pain by a Visual Analog Scale

  Pain is assessed by a physiotherapist thanks to VAS score.

  Day 7 and month 2

Secondary Outcomes (6)

• Sensibility by a physiotherapist assessment

  at month 2

• Change from baseline spasticity by ASHWORTH modified scale.

  Day 7 and at month 2

• Change from baseline locomotion by Medical Research Council scale.

  Day 7 and at month 2

• Change from baseline depression by MADRS

  Day 7 and at month 2

• Change from baseline functional independence by Barthel Index measure

  Day 7 and at month 2

Study Arms (2)

SP-ED

ACTIVE COMPARATOR

Classic use

Device: SYSTAM - SP-ED

4P-ED

EXPERIMENTAL

Literature update

Device: Ultrasling ER 15°Donjoy - 4P-ED

Interventions

SYSTAM - SP-ED DEVICE

* Positioning in bed, wheelchair and standing with classics materials (pillow, holds, sling) on day J0 until J7 or Exit. * Daily passive mobilisation of the upper member by a therapist. * Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)

SP-ED

Ultrasling ER 15°Donjoy - 4P-ED DEVICE

* Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction) on day J0 until J7 or Exit. * A training of the patient and members of family on pathology, risk, use of material * Daily passive mobilization of the upper member by a therapist. * Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers) and active patient training for use the other side for support hemiplegic shoulder to prevent diastasis.

4P-ED

Eligibility Criteria

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

You may qualify if:

• NIHSS : level of consciousness ≤ 1
• Patient was admitted in a stroke unit until 48 h post stroke
• Locomotion :Medical Research Council scale ≤ 2 shoulder motility
• Spasticity : Ashworth scale ≤ 1 shoulder's adductor muscle
• Simple commands understanding: subtest 04 - Executive orders of Boston Diagnostic Aphasia Examination (BDAE)

You may not qualify if:

• Consciousness disorder (NIHSS\>1)
• Shoulder disease background (stroke damage side)
• Depression background under 6 months as diagnosed according to DSM-IV
• Upper limb anesthesia
• Severe aphasia

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Stroke; Shoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amandine COOK

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: September 30, 2015
• Study Start: July 9, 2012
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

FR (1)