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Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury (MCRCT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292811
First Posted: February 10, 2011
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Rick Hansen Foundation
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute
February 7, 2011
February 10, 2011
September 28, 2016
January 2011
January 2017   (Final data collection date for primary outcome measure)
Functional Independence Measure to measure burden of care [ Time Frame: Change from baseline at 8 weeks and at 6 month follow up ]
The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. It is viewed as the most useful tool for the assessment of progress during inpatient rehabilitation, and measures independent performance in self-care, sphincter control, transfers, locomotion, communication, and social cognition. By adding the points for each item, the possible total score ranges from 18 (lowest) to 126 (highest) level of independence
Same as current
Complete list of historical versions of study NCT01292811 on ClinicalTrials.gov Archive Site
  • Graded Redefined Assessment of Strength Sensibility and Prehension to assess gross motor function and sensation of the hand [ Time Frame: Change from basline upon completion of therapy (8 weeks)and at 6 month follow ]
    This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population. The key features of the GRASSP are: 1) measures each of the sensory, motor and grasping capabilities
  • Jamar® Hydraulic Hand Dynamometer to measure grip and pinch force [ Time Frame: Change from Baseline at 8 weeks and 6 months ]
    Jamar® Hydraulic Hand Dynamometer will be used to measure isometric grip force. The range of the sensor is from 0 to 90 kg.
  • Action Research Arm Test to measure upper extremity function [ Time Frame: Change from Baseline at 8 weeks and 6 months ]
  • Toronto Rehab Hand Function Test (TR-HFT)to measure gross motor hand function [ Time Frame: Change from Baseline at 8 weeks and 6 months ]
  • REJOYCE to measure change in upper extremity range of motion and various grip strengths [ Time Frame: Change from Baseline at 8 weeks and 6 months ]
  • Spinal Cord Independence Measure to measure impairment [ Time Frame: Change from Baseline at 8 weeks and 6 months ]
Same as current
Not Provided
Not Provided
 
Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Spinal Cord Injury
  • Device: Functional Electrical Stimulation (Compex Motion Stimulator)
    Functional electrical Stimulation:Parameters of stimulation: 1) balanced, biphasic, current regulated electrical pulses; 2) pulse amplitude from 8 to 50 mA (typical values 17-26 mA); 3) pulse width from250 to 300 μs; and 4) pulse frequency from 20 to 70 Hz (typical value 25 to 40 Hz).
    Other Name: Functional Electrical Stimulation
  • Other: Conventional Occupational therapy

    The Control group will receive conventional occupational therapy pertaining to hand function [15].

    The conventional therapy represents control activities against which the FES therapy will be assessed. The 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 but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.

  • Experimental: Functional electrical Stimulation
    The functional electrical stimulation for the treatment group will begin by designing a stimulation protocol that can generate the palmar and/or the lateral grasp on demand. In other words, the stimulation sequence (protocol) will be developed for each patient individually using either Compex Motion or HEWHS stimulator; this will allow the patient, who otherwise cannot grasp, to do so with the system. Both stimulators will be used to deliver the same FES therapy. Stimulation parameters are: 1) balanced, biphasic, current regulated electrical pulses; 2) pulse amplitude from 8 to 50 mA (typical values 17-26 mA); 3) pulse width from 250 to 300 μs; and 4) pulse frequency from 20 to 70 Hz (typical value 25 to 40 Hz).
    Intervention: Device: Functional Electrical Stimulation (Compex Motion Stimulator)
  • Control Group

    The Control group will receive conventional occupational therapy pertaining to hand function [15].

    The conventional therapy represents control activities against which the FES therapy will be assessed. The 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 but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training.

    Intervention: Other: Conventional Occupational therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
January 2018
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01292811
10-048
No
Not Provided
Not Provided
Milos Popovic, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
  • Rick Hansen Foundation
  • Ontario Neurotrauma Foundation
Principal Investigator: Dr. Milos R Popovic, PhD Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP