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

This study is currently recruiting participants.
Verified December 2013 by Toronto Rehabilitation Institute
Sponsor:
Collaborators:
Rick Hansen Foundation
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Milos Popovic, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01292811
First received: February 7, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Spinal Cord Injury
Device: Functional Electrical Stimulation (Compex Motion Stimulator)
Other: Conventional Occupational therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Functional Independence Measure to measure burden of care [ Time Frame: Change from baseline at 8 weeks and at 6 month follow up ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Toronto Rehab Hand Function Test (TR-HFT)to measure gross motor hand function [ Time Frame: Change from Baseline at 8 weeks and 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Spinal Cord Independence Measure to measure impairment [ Time Frame: Change from Baseline at 8 weeks and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: January 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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.

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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292811

Contacts
Contact: Naaz M Kapadia, MSc (Rehab) 416-597-3422 ext 6310 kapadia.naaz@torontorehab.on.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute Recruiting
Toronto, Ontario, Canada, M4G 3V9
Contact: Naaz M Kapadia, MSc (rehab)    416-597-3422 ext 6310    kapadia.naaz@torontorehab.on.ca   
Contact: Vera Zivanovic, M.D.    416-597-3422 ext 6119    zivanovic.vera@torontorehab.on.ca   
Principal Investigator: Prof. Mary Verrier, MSc         
Sponsors and Collaborators
Toronto Rehabilitation Institute
Rick Hansen Foundation
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Dr. Milos R Popovic, PhD Toronto Rehabilitation Institute
  More Information

No publications provided

Responsible Party: Milos Popovic, Toronto Rehab Chair in Spinal Cord Injury Research, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01292811     History of Changes
Other Study ID Numbers: 10-048
Study First Received: February 7, 2011
Last Updated: December 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:
Spinal Cord Injury
Functional Electrical Stimulation
Hand function
Tetraplegia

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 22, 2014