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FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
FES Therapy
FES Therapy
Conventional Occupational Therapy
Sponsored by
Toronto Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • traumatic spinal cord lesion between C4 and C7
  • injury at least 24 months prior to enrolling in the study.

Exclusion criteria:

  • uncontrolled hypertension
  • susceptibility to autonomic dysreflexia
  • pressure ulcer
  • cardiac pacemaker
  • skin rash

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FES Therapy

Conventional Occupational Therapy

Arm Description

FES Therapy

The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.

Outcomes

Primary Outcome Measures

REL Hand Function Test

Secondary Outcome Measures

GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension
Functional Independence Measures (FIM)
Spinal Cord Independence Measure (SCIM)
Client perception of treatment

Full Information

First Posted
September 23, 2010
Last Updated
September 24, 2012
Sponsor
Toronto Rehabilitation Institute
Collaborators
Rick Hansen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01208688
Brief Title
FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI
Official Title
FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Rick Hansen Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES Therapy
Arm Type
Experimental
Arm Description
FES Therapy
Arm Title
Conventional Occupational Therapy
Arm Type
Active Comparator
Arm Description
The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.
Intervention Type
Device
Intervention Name(s)
FES Therapy
Other Intervention Name(s)
Neuroprosthesis
Intervention Description
Treatment group received functional electrical stimulation and control group received conventional occupational therapy.
Intervention Type
Device
Intervention Name(s)
FES Therapy
Intervention Description
Subjects will be divided into one of two groups: a) subjects that will be trained with neuroprosthesis for grasping and b) the control group. The control group will be administered standard occupational therapies appropriate for recovery of grasping function in SCI subjects. In group a), neuroprosthesis for grasping will be used to train subjects to reach, grasp and manipulate various objects in the activities of daily living.
Intervention Type
Other
Intervention Name(s)
Conventional Occupational Therapy
Intervention Description
The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.
Primary Outcome Measure Information:
Title
REL Hand Function Test
Time Frame
45 min
Secondary Outcome Measure Information:
Title
GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension
Time Frame
60 min
Title
Functional Independence Measures (FIM)
Time Frame
35 min
Title
Spinal Cord Independence Measure (SCIM)
Time Frame
35 min
Title
Client perception of treatment
Time Frame
15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: traumatic spinal cord lesion between C4 and C7 injury at least 24 months prior to enrolling in the study. Exclusion criteria: uncontrolled hypertension susceptibility to autonomic dysreflexia pressure ulcer cardiac pacemaker skin rash
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milos R Popovic, Ph.d
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.toronto-fes.ca
Description
Rehabilitation Engineering Laboratory

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FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI

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