Spinal Cord InjuryMCRCTNCT01292811
Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
A study testing Functional Electrical Stimulation (Compex Motion Stimulator) and Conventional Occupational therapy in people with Spinal Cord Injury, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Functional Electrical Stimulation (Compex Motion Stimulator) and Conventional Occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to 3 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- •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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Functional Electrical Stimulation (Compex Motion Stimulator), Conventional Occupational therapy
- Keywords
- Spinal Cord Injury, Functional Electrical Stimulation, Hand function, Tetraplegia
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (Compex Motion Stimulator)Device
Also called Functional Electrical Stimulation
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).
Conventional Occupational therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional electrical Stimulation | Experimental | 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). Receives: Device: Functional Electrical Stimulation (Compex Motion Stimulator) |
| Control Group | Other | 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. Receives: Other: Conventional Occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure to measure burden of care
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
Measured: Change from baseline at 8 weeks and at 6 month follow up
Secondary outcomes (6)
Graded Redefined Assessment of Strength Sensibility and Prehension to assess gross motor function and sensation of the hand
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
Measured: Change from basline upon completion of therapy (8 weeks)and at 6 month follow
Jamar® Hydraulic Hand Dynamometer to measure grip and pinch force
Jamar® Hydraulic Hand Dynamometer will be used to measure isometric grip force. The range of the sensor is from 0 to 90 kg.
Measured: Change from Baseline at 8 weeks and 6 months
Action Research Arm Test to measure upper extremity function
measure upper extremity function
Measured: Change from Baseline at 8 weeks and 6 months
Toronto Rehab Hand Function Test (TR-HFT)to measure gross motor hand function
measure gross motor hand function
Measured: Change from Baseline at 8 weeks and 6 months
REJOYCE
to measure change in upper extremity range of motion and various grip strengths
Measured: Change from Baseline at 8 weeks and 6 months
Spinal Cord Independence Measure
to measure impairment
Measured: Change from Baseline at 8 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJan 2011
- Primary completion3 Dec 2014
- Study completion3 Dec 2014
Why it stopped: Financial assistance from agency withdrawn due to financial issues at their end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Foundation, Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Milos Popovic, Toronto Rehabilitation Institute
- Investigators
- Dr. Milos R Popovic, PhD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292811
- Sponsor's protocol ID
- 10-048
- Acronym
- MCRCT
- Status last verified
- Sep 2021
- First submitted
- 7 Feb 2011
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Upper Limb Function in Individuals With Sub-Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01292811
- Acronym / sponsor ID
- MCRCT / 10-048
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Functional Electrical Stimulation, Hand function, Tetraplegia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial assistance from agency withdrawn due to financial issues at their end.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Rick Hansen Foundation, Ontario Neurotrauma Foundation
- Study start
- Jan 2011
- Primary completion
- 3 Dec 2014 (actual)
- Study completion
- 3 Dec 2014 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional electrical Stimulation | Experimental | Device: Functional Electrical Stimulation (Compex Motion Stimulator)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). |
| Control Group | Other | Other: Conventional Occupational therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical Stimulation (Compex Motion Stimulator)Also: Functional Electrical StimulationFunctional 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). | Device | Functional electrical Stimulation |
| Conventional Occupational therapyThe 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 | Control Group |
Primary outcome
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
6 secondary outcomes
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
Jamar® Hydraulic Hand Dynamometer to measure grip and pinch force
Time frame: Change from Baseline at 8 weeks and 6 months
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
Time frame: Change from Baseline at 8 weeks and 6 months
Spinal Cord Independence Measure
Time frame: Change from Baseline at 8 weeks and 6 months
Results and safety
The study was stopped early (reason given: Financial assistance from agency withdrawn due to financial issues at their end.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Milos R Popovic, PhD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (Compex Motion Stimulator) and Conventional Occupational therapy in people with Spinal Cord Injury, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Financial assistance from agency withdrawn due to financial issues at their end.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.