Clinical Trials Logo

Clinical Trial Summary

Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.


Clinical Trial Description

The main objective of this study is to determine the effectiveness of a new treatment regime that uses a neuroprosthesis for the improvement and recovery of grasping functions in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients with hemiplegic arm in the recovery of reaching and grasping 1, and our preliminary work indicates that this may also be the case with SCI patients 3. Further, aside from the potential of promoting voluntary grasp in SCI patients, this novel therapeutic approach may also impact the way service is currently delivered in SCI rehabilitation settings.

A neuroprosthesis for grasping is a device that can improve or restore the grasping, holding, and releasing functions in persons with SCI 2, 3. The neuroprosthesis applies functional electrical stimulation (FES) to artificially generate a muscle contraction by applying short current pulses to motor nerves innervating muscles. FES can be applied to individuals with incomplete SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner 4. FES was originally envisioned as an intervention that was 'permanent' in nature. In other words, an individual had to wear/use an FES orthotic device at all times if s/he wanted to generate the function that was impaired by SCI 4. Our application of the neuroprosthesis for grasping in this proposal presents a departure from this standard and established approach of FES application. Rather than having people be dependent on the neuroprosthesis to perform their activities of daily living (ADL), we plan to use the neuroprosthesis for grasping as a short-term intervention that will help SCI individuals recover voluntary grasping function. Hence, we believe that those participants who undergo our FES therapy with the neuroprosthesis should be able to perform grasping functions without its use once the treatment program is completed.

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 3, 5, 6. 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 incomplete SCI. Since 1999, the Co-PI of this application, Dr. Milos Popovic and Dejan Popovic's team from the University of Belgrade have reported anecdotal evidence that some C5 to C7 SCI individuals who were unable to voluntarily grasp, were later able to do so after intensive training with a neuroprosthesis for grasping 2, 7, 8, 9. They observed that approximately 20 to 25% of the individuals who trained with the FES systems were able to grasp without the assistance of the neuroprosthesis once the systems were removed. Although this evidence has been presented in several peer-reviewed publications, there have been no comprehensive studies to date that have investigated the long-term effects of FES treatment on recovery of the voluntary grasping function in persons with SCI. Consequently, this study seeks to 1) investigate whether a series of orchestrated FES therapies can be applied to re-train/improve voluntary grasping function in acute SCI individuals, and; 2) to determine whether this therapy will yield better results than conventional occupational therapy. Specifically, we will recruit participants who have C5 to C7 incomplete SCI. These individuals typically can generate weak wrist extension but can neither flex, extend, abduct or adduct the fingers, nor flex, extend, abduct or adduct the thumb. Our therapy will be used to help these individuals recover some or all of these functions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00221117
Study type Interventional
Source Toronto Rehabilitation Institute
Contact
Status Completed
Phase N/A
Start date August 2005
Completion date September 2010

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A