Treatment of Shoulder Subluxation in Chronic Stroke Patients

19:58 EDT 3rd May 2015 | BioPortfolio

Summary

The study looks at treatments for reversing chronic shoulder subluxation after a stroke. It compares electrical stimulation with surface electrodes (stimulation through the skin) with intra-muscular stimulation (from inside the muscle)using an implanted micro-stimulator (BION). Subjects are put either in a surface stimulation or a BION® group. In the BION® group, two BION®s are implanted in the shoulder, the medial deltoid and supraspinatus muscles. Treatment consists of a baseline of 6 weeks, and 6 weeks of therapy, consisting of 2 sessions per day for 10 to 30 minutes each time. This is followed by 6 weeks without therapy. If testing shows that after 6 weeks of therapy there is no reversal of subluxation, more intense therapy is carried out for another 6 weeks. Treatment is similar in the surface electrode group, but surface electrodes deliver the stimulation instead of BION®s. A total of 30 subjects is expected to complete the study.

Description

The BION™ is a novel implantable neuromuscular stimulator whose intended use in this study is to reanimate the shoulder muscles of stroke survivors with shoulder subluxation. Strokes are considered to be the most important cause of adult disability in North America, with 500,000 new cases per year in the U.S. (National Stroke Association) and 45,000 in Canada (Langton-Hewer, 1990; Shuaib & Hachinski, 1991). Three-quarters of these patients survive and half of the survivors have substantial muscle weakness after 6 months (Gresham et al., 1979) with little chance of spontaneous recovery (Anderson, 1990; Bonita & Beaglehole, 1988). The most commonly affected region in the early phases of recovery is the shoulder; 80% of hemiplegic stroke patients suffer from shoulder subluxation and associated chronic pain (Smith et al., 1980). The shoulder muscles that are normally active tonically are flaccidly paralyzed; the weight of the pendant arm gradually stretches and damages the atrophic muscles and ligaments, allowing the head of the humerus to descend out of the glenoid fossa. This results in chronic shoulder pain that is difficult to treat and tends to obstruct physical therapy directed toward regaining some use of the paretic arm. Our hypothesis is that electrical stimulation delivered by the BIONs should be fundamentally equivalent to muscle activation achieved voluntarily or by transcutaneous electrical nerve stimulation (TENS), but that the BIONs will prove to be a more clinically acceptable and effective approach. The BION system consists of the BION implants themselves, a controller that is operated by the study participant, and fitting hardware and software used by the clinician to implant, test, and program BION function.

In this study, the BION will be used to reanimate the shoulder muscles of stroke survivors experiencing shoulder subluxation. The objective of this study is to evaluate the safety and efficacy of intramuscular stimulation of BIONs to correct established, symptomatic shoulder subluxation in chronic stroke survivors. The results of intramuscular stimulation by BIONs will be compared with the results of treatment with conventional therapy: surface stimulation.

Degree of shoulder subluxation will be the primary outcome measure for the study. We have included other (secondary) outcome measures (i.e., muscle strength, range of motion, functional activity, spasticity/tone, subject satisfaction and pain) which may reveal secondary benefits of treatment with BIONs. The investigation is expected to last up to 21 weeks for each study participant. The study will be completed over a 5-year period.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Shoulder Dislocation

Intervention

BION stimulation

Location

Rancho Los Angeles National Rehabilitation Center
Downey
California
United States
90242

Status

Active, not recruiting

Source

University of Southern California

Results (where available)

View Results

Links

Clinical Trials [561 Associated Clinical Trials listed on BioPortfolio]

Bion Occipital Nerve Stimulation (ONS) Compassionate Use Study

The purpose of this compassionate use study is to provide clinical and technical support of the Bion® microstimulator system to the subjects who have decided to keep the system for relief...

Immobilization in External Rotation After First Time Anterior Shoulder Dislocation

The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the bes...

Immobilization in External Rotation of Acute Shoulder Dislocations

The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditi...

Prevention of Post-Stroke Hand/Wrist Flexion Deformity

The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to mov...

Bion for Occipital Nerve Stimulation

This is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches...

PubMed Articles [3075 Associated PubMed Articles listed on BioPortfolio]

Bilateral anterior shoulder dislocation.

Unilateral anterior shoulder dislocation is one of the most common problems encountered in orthopedic practice. However, simultaneous bilateral anterior dislocation of the shoulders is quite rare.

First-time anterior shoulder dislocations: should they be arthroscopically stabilised?

The glenohumeral joint is inherently unstable because the large humeral head articulates with the small shadow glenoid fossa. Traumatic anterior dislocation of the shoulder is a relatively common athl...

Posterior shoulder dislocation with ipsilateral proximal humerus type 2 physeal fracture: case report.

In pediatric patients, proximal humeral physeal fractures are uncommon injuries compared with distal physeal fractures. Usually, the growth plate is the most vulnerable site of fracture in the proxima...

Bilateral, locked, recurrent anterior shoulder dislocation: case report.

Bilateral anterior dislocation of the shoulder is a rare condition. Most of the cases are seen as posterior dislocations which generally occur during diffuse tonic-clonic contractions of epileptic sei...

MR Arthrography of the Shoulder: Technical Update and Clinical Applications.

Direct MR arthrography of the shoulder is a safe, relatively easy procedure that can increase diagnostic confidence in the evaluation of rotator cuff and labroligamentous disorders compared with conve...

Medical and Biotech [MESH] Definitions

Displacement of the HUMERUS from the SCAPULA.

Congenital dislocation of the hip generally includes subluxation of the femoral head, acetabular dysplasia, and complete dislocation of the femoral head from the true acetabulum. This condition occurs in approximately 1 in 1000 live births and is more common in females than in males.

Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin.

Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.

Stimulation at an intensity below that where a differentiated response can be elicited.

More From BioPortfolio on "Treatment of Shoulder Subluxation in Chronic Stroke Patients"

Search BioPortfolio:
Loading
Advertisement

Relevant Topics

Neurology - Central Nervous System (CNS)
Latest News Clinical Trials Research Drugs Reports Corporate
Neurology is the branch of medicine concerned with nerves; both the central nervous system and the peripheral nervous system. This includes strokes and disorders affecting the brain aswell as spinal cord damage and peripheral neuropathies.The complexity ...

Rheumatology
Latest News Clinical Trials Research Drugs Reports Corporate
Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Dictionary). It is an active area of medical research, because of the d...

Advertisement