Customizing the Body-Machine Interface for Spinal Cord Injuries
This study is evaluating whether it is possible to develop personalized interfaces for people with tetraplegia.
See full descriptionAbout the trial for Spinal Cord Injuries
Treatment Groups
This trial involves 2 different treatments. Customizing The Body-Machine Interface is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Customizing the Body-Machine Interface will improve 1 primary outcome and 3 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Baseline and 8 months.
Who is running the study
Principal InvestigatorPatient Q & A Section
Can spinal cord injuries be cured?
Although the prognosis for patients with SCI is better than for the general population, there does not appear to be a cure for SCI. The best we can propose is that patients should be managed in a way that meets their individual needs and that this should include an awareness of their own expectations and an assessment of their abilities and their wish to cope with their disability. In the future, however, new knowledge will allow a clearer picture to emerge.
What are the signs of spinal cord injuries?
The signs of spinal cord injuries include pain, paralysis, bladder dysfunction, bowel and bladder dysfunction, incontinence, and loss of bladder or bowel control. Also an intact sensation of the skin is a good indicator for the preservation of urinary or anal sphincters.
What is spinal cord injuries?
Nearly 90,000 new cases occur in the US each year. Although they can affect many functions of the body, nearly half of cases involve a single, complete loss of muscle and nerve function, which is termed a complete transection. In the USA, the injury occurs most frequently in those 25-40 years old (27%), and is equally frequent in males and females (14% male; 13% female). The National Institutes of Health Spinal Cord Injury Clinical Research Center (NINCDS C-R-16) at the National Institutes of Health sponsors the S-CORT study.
What causes spinal cord injuries?
In a country that has only moderate traumatic injury incidence, the majority of injuries are nontraumatic. However, the incidence of SCI is increasing, especially at a younger age.
What are common treatments for spinal cord injuries?
In the first two decades after an injury, treatment for patients with spinal cord contusions includes immediate conservative measures with careful attention to patients' comfort and treatment of complications, and supportive care, including physical therapy and occupational therapy. Patients with epidural hematoma may benefit from surgical decompression if symptoms are mild but rapid neurological deterioration develops, whereas patients with mild symptoms that do not improve when treated with nonsurgical measures may benefit from surgical decompression at some interval after injury.
How many people get spinal cord injuries a year in the United States?
Almost 19,500 Americans are hospitalized per year with spinal cord injuries. The rate of spinal cord injuries tripled between 1955 and 1973. Preventable causes have contributed to the rapid increases of the prevalence of spinal cord injuries, and the national rate may be as high as 1.35 spinal cord injury admissions/100,000 population.
What is the average age someone gets spinal cord injuries?
The average age of a SCI sufferer is 44, or approximately 28 years younger than the average American. While still young, [not all doctors in the United States are aware that SCIs are more frequent in [young] black men than in [young] white men] (https://www.fhi.org/sites/default/files/health%20resources/fact-sheets/fact-sheets-courses-teacher/med%20-friendly_lessons.pdf). As a result, spinal cord injury is less likely to be a concern in [young, white] men.
What is the primary cause of spinal cord injuries?
Recent findings, trauma was the sole primary cause of thoraco-lumbar and lumbar SCIs by itself or in combination with another injury. It has become a trend to place less emphasis on the history and physical examination of the spinal cord in the workup of SCI. As we gain more knowledge about the causes of SCI, we can more accurately prevent SCI and other spinal cord injuries.
Is customizing the body-machine interface typically used in combination with any other treatments?
The majority of participants, 66%, had some form of customizing treatment in combination with other treatments. Customizing treatments may be of value when combined with other treatments to optimize the effects of these treatments and to enhance recovery. Inclusion and exclusion criteria from clinical studies of rehabilitation in combination with other treatments may need to adjusted to be appropriate for patients who require customized therapy to address the individual needs of their condition. Copyright © 2015 John Wiley&Sons, Ltd.
Has customizing the body-machine interface proven to be more effective than a placebo?
Results from a recent paper shows that, by modifying the way that the BM-I interacts with the human, a new method for enhancing functional recovery of the human body and for enhancing recovery in the whole human system can be developed.
How does customizing the body-machine interface work?
With a single system design for both upper- and lower- extremities, the most effective BMA design that can support all users is a modular one. With current hardware, this would be a multi-chambered FSM that includes an upper extremities module, a lower extremities module and a waist module. The waist module will allow users to control their BMA remotely without putting forward full weight on their upper limbs or knees.