Stroke Clinical Trial
Official title:
A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.
The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers. There is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.
CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'. Further, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply. There is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso. The geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|