Clinical trial NCT01292811: Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
Official title: Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Functional Electrical Stimulation
Hand function
Tetraplegia
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Rick Hansen Foundation
name: Ontario Neurotrauma Foundation
First posted: 2011-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this research program is to conduct a multi-site clinical randomized control trial that will evaluate the efficacy of functional electrical stimulation based upper limb intervention for people with tetraplegia. This will involve recruiting 84 persons with sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton) and will serve to evaluate three new Canadian hand function assessments that have been specifically developed for persons with tetraplegia. Although these assessments have been recently tested and have shown considerable promise, further evaluation on their clinical utility (in particular their responsiveness and validity) is required. As well, they need to be compared with one another to determine whether any of these tests is more appropriate for clinical applications or whether further test reduction or augmentation may be required. Having measures that are sensitive and accurate in assessing hand function is key for systematically evaluating emerging therapeutic interventions.

Detailed description: Sustaining a spinal cord injury can impose significant physical dependency and results in financial and psychological challenges to the individual, family and the community at large. For persons with cervical levels of injury (tetraplegia), there is often the loss of hand and upper limb function, which is one of the most devastating consequences of spinal cord injury. The use of hands and upper limbs is needed for daily activities such as feeding, dressing, bathing and toileting. Good hand function plays an important role in the ability to transfer from a bed to a wheelchair, to sit up or to lie down. Not surprisingly, the majority of people with tetraplegia rate recovery of hand function as their highest priority.

One of the most promising approaches to improving hand function is functional electrical stimulation, which uses bursts of short electrical pulses to generate muscle contractions. Functional electrical stimulation enables a person, who would otherwise have paralyzed hands, to grasp and release objects. Although Canadian researchers are at the forefront of upper limb rehabilitation, and have recently developed state-of-the-art therapeutic treatments that involve functional electrical stimulation, there is a strong need to evaluate the efficacy of this intervention. A similar situation also exists with upper limb function assessments. At least three clinically promising upper limb assessments have been recently developed in Canada for individuals with spinal cord injury, which require further evaluation to determine their effectiveness.

The objective of this research program is to conduct a multi-site clinical randomized control trial that will evaluate the efficacy of functional electrical stimulation based upper limb intervention for people with tetraplegia. This will involve recruiting 84 persons with sub-acute tetraplegia across four sites (Montreal,Toronto, Fredericton and Edmonton) and will serve to evaluate three new Canadian hand function assessments that have been specifically developed for persons with tetraplegia. Although these assessments have been recently tested and have shown considerable promise, further evaluation on their clinical utility (in particular their responsiveness and validity) is required. As well, they need to be compared with one another to determine whether any of these tests is more appropriate for clinical applications or whether further test reduction or augmentation may be required. Having measures that are sensitive and accurate in assessing hand function is key for systematically evaluating emerging therapeutic interventions.

The findings of this multi-site clinical trial have the potential to elevate the current standard of upper limb rehabilitation related to hand function by providing higher levels of evidence on the efficacy of functional electrical stimulation therapy intervention. Also, dissemination of the new knowledge gained will translate into better clinical practice since occupational therapists will be able to select better rehabilitation strategies for improving hand function based on solid evidence. By improving the standards of practice, persons with spinal cord injury will have access to a wider range of treatment interventions to restore and improve function in their hands.

Eligibility criteria: Inclusion Criteria:

* Sustained a traumatic incomplete SCI between C4 and C7 levels
* 18 years of age or older
* Less than 6 months post injury
* Unable to grasp objects
* Participants must have functional biceps and deltoid muscle strength which allows them to place their hand in the working space in front of themselves, i.e., at least a grade 3 on manual muscle testing
* Participants should have a clear understanding of the goal of the study, which is to compare the FES technology to conventional occupational therapy (which may or may not enhance recovery)
* Participants should be able to read and understand and provide informed consent, and in a situation where there is a difficulty in understanding ( e.g. language barrier), have a relative or friend willing and able to accompany you to all treatment and assessment sessions, for your own safety

Exclusion Criteria:

•Contraindications for FES:

* cardiac pacemakers
* skin lesions, allergy, wound or rash at potential electrode sites
* denervation of targeted muscles
* pressure ulcers
* patient suffers from the cardiovascular conditions such as hypertension that is uncontrolled or autonomic dysreflexia requiring medication
* Patients on Botox therapy for their upper limb or have received Botox for the upper extremity in the last six months
* Participation in any other interventional study that may affect upper extremity function
* Participants with co existing Traumatic brain injury

Primary outcomes:
measure: Functional Independence Measure to measure burden of care
timeFrame: Change from baseline at 8 weeks and at 6 month follow up
Secondary outcomes:
measure: Graded Redefined Assessment of Strength Sensibility and Prehension to assess gross motor function and sensation of the hand
timeFrame: Change from basline upon completion of therapy (8 weeks)and at 6 month follow
measure: Jamar® Hydraulic Hand Dynamometer to measure grip and pinch force
timeFrame: Change from Baseline at 8 weeks and 6 months
measure: Action Research Arm Test to measure upper extremity function
timeFrame: Change from Baseline at 8 weeks and 6 months
measure: Toronto Rehab Hand Function Test (TR-HFT)to measure gross motor hand function
timeFrame: Change from Baseline at 8 weeks and 6 months
measure: REJOYCE
timeFrame: Change from Baseline at 8 weeks and 6 months
measure: Spinal Cord Independence Measure
timeFrame: Change from Baseline at 8 weeks and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Dr. Milos R Popovic, PhD
role: PRINCIPAL_INVESTIGATOR
References: