Spinal Cord Injuries Clinical Trial
Official title:
FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI
The main objective of this study is to determine the effectiveness of a new treatment regime that uses electrical stimulation for the improvement of hand function in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients, and our preliminary work indicates that this may also be the case with SCI patients. Our approach to functional electrical stimulation (FES) represents a departure from the established FES approaches, which involve developing assistive devices for permanent, everyday use. Instead, we use FES as a therapeutic intervention that will help individuals with quadriplegia recover voluntary grasping function. Investigators believe that subjects who undergo FES therapy should be able to grasp objects without stimulation once the treatment program is completed.
The primary objective of the present prospective randomized controlled trial is to
investigate if the FES therapy would generate similar level of the improvement in hand
function in chronic C4 to C7 incomplete and complete SCI individuals as compared to
conventional occupational therapy. For the purpose of this study individuals with chronic
SCI are those who sustained injury at least 24 months prior to enrolling in the study. The
FES or conventional occupational therapy will be administered thrice-weekly for 13 weeks
(i.e., 39 sessions in total) to 60 individuals with SCI. Half of the participants will
receive the FES therapy and the other half will receive conventional occupational therapy of
equal intensity. The secondary objectives are to evaluate if the improvements in hand
function will improve participants' activities of daily living skills and their satisfaction
with life.
Background and Significance The sudden onset of a traumatic SCI can result in severe
impairments in the motor and/or sensory functions of the body and limbs. A significant part
of the expenses incurred after SCI are associated with the need of many individuals with SCI
to have a caregiver assist them with various daily tasks such as eating, grooming and
ambulation. This dependence,besides being financially strenuous for the patients and their
families, frequently precipitates psychological problems such as depression, social
withdrawal and inactivity.For persons with quadriplegia, hand function is essential for
achieving a high level of independence in their activities of daily living. In a recent
survey, it was revealed that the majority of people with quadriplegia rate recovery of hand
function as the highest priority.FES is one of the most promising approaches towards
improving grasping function in SCI individuals with permanent hand impairment. A
neuroprosthesis for grasping is a device that can improve or restore the grasping, holding,
and releasing functions in persons with SCI [1]. The neuroprosthesis applies FES to
artificially generate a muscle contraction by applying short current pulses to motor nerves
innervating muscles. FES can be applied to individuals with SCI to help them restore
functions such as walking and grasping by contracting groups of paralyzed muscles in an
orchestrated manner.Despite the usefulness of neuroprostheses in improving functionality,
SCI consumers, their therapists and psychiatrists remain hesitant to use the technology. For
instance, Popovic et al. (not the principal investigator) reported that consumers who
retained some dexterity without an FES-assisted system hesitated to use the surface FES
device to manipulate small objects, even though they gained significant improvements in
function when wearing it. Also, some neuroprostheses such as the Freehand system require
invasive procedures for their implementation, which is often unappealing to SCI consumers.
These issues with FES, along with the mindset that impairments in functionality are
permanent, have led to the design of systems that SCI consumers have little interest in
using over long periods of time. Our application of the neuroprosthesis for grasping in this
proposal presents a departure from this standard and established approach of FES
application. The Compex Motion neuroprosthesis, developed by Drs. Popovic (principal
investigator) and Keller1,is a flexible device designed to improve grasping function in both
SCI and stroke patients. This multi-channel surface stimulation system for grasping provides
both palmar and lateral grasps, and holds a number of advantages over other existing
neuroprostheses.Firstly, whereas most other systems were designed and used exclusively as
permanent orthotic systems for SCI consumers in order to allow them to grasp, the Compex
Motion was designed to help retrain voluntary grasping function. Hence, the device is meant
to be used as part of the rehabilitation process towards improving functionality as opposed
to merely substituting it. Secondly, the Compex Motion is a surface FES system that does not
require implanted systems or possesses features that limit flexibility. These features make
it a more suitable option for rehabilitation applications, which typically require portable,
flexible, non-invasive, and multi-channel FES systems. Thirdly, although the Compex Motion,
Handmaster, and Belgrade Grasping-Reaching System have been used to retrain voluntary
grasping function in individuals with stroke, only the Compex Motion has been used for this
purpose in individuals with SCI. The advantages of the Compex Motion system over other FES
systems is its potential for retraining function in SCI patients and the fact that the
system's application does not require the long-term support/commitment of clinical and
engineering specialists. Recent innovative advances in FES applications, spearheaded by our
team, clearly indicate that the short-term, therapeutic intervention of the neuroprosthesis
for grasping can enhance voluntary function in individuals with SCI. These studies also
suggest that this novel method of applying FES to augment functional improvement has the
potential to improve overall physical and psychological well being of persons with SCI.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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