Spinal Cord InjuriesPhase 2NCT01208688
FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI
A Phase 2 study testing FES Therapy and Conventional Occupational Therapy in people with Spinal Cord Injuries, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- FES Therapy and Conventional Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 2
- 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
- traumatic spinal cord lesion between C4 and C7
- injury at least 24 months prior to enrolling in the study.
Who cannot join
- uncontrolled hypertension
- susceptibility to autonomic dysreflexia
- pressure ulcer
- cardiac pacemaker
- skin rash
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES Therapy, Conventional Occupational Therapy
- Keywords
- Spinal Cord Injuries
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES TherapyDevice
Also called Neuroprosthesis
Treatment group received functional electrical stimulation and control group received conventional occupational therapy.
FES TherapyDevice
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.
Conventional Occupational TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FES Therapy | Experimental | FES Therapy Receives: Device: FES Therapy |
| Conventional Occupational Therapy | Active comparator | 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. Receives: Other: Conventional Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
REL Hand Function Test
Measured: 45 min
Secondary outcomes (4)
GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension
Measured: 60 min
Functional Independence Measures (FIM)
Measured: 35 min
Spinal Cord Independence Measure (SCIM)
Measured: 35 min
Client perception of treatment
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Foundation
- Responsible party
- Principal investigator, Milos Popovic, Toronto Rehabilitation Institute
- Investigators
- Milos R Popovic, Ph.d, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208688
- Sponsor's protocol ID
- 2009-36
- Other IDs
- SCISN-2009-36
- Status last verified
- Sep 2012
- First submitted
- 23 Sep 2010
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FES Therapy:Restoring Voluntary Grasping Function in Chronic SCI
- ClinicalTrials.gov ID
- NCT01208688
- Acronym / sponsor ID
- 2009-36
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Rick Hansen Foundation
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Sep 2010 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES Therapy | Experimental | Device: FES TherapyFES Therapy |
| Conventional Occupational Therapy | Active comparator | Other: Conventional Occupational TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- traumatic spinal cord lesion between C4 and C7
- injury at least 24 months prior to enrolling in the study.
Key exclusion criteria (5 listed)
- uncontrolled hypertension
- susceptibility to autonomic dysreflexia
- pressure ulcer
- cardiac pacemaker
- skin rash
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 |
|---|---|---|
| FES TherapyAlso: NeuroprosthesisTreatment group received functional electrical stimulation and control group received conventional occupational therapy. | Device | FES Therapy |
| FES TherapySubjects 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. | Device | FES Therapy |
| Conventional Occupational TherapyThe 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. | Other | Conventional Occupational Therapy |
Primary outcome
REL Hand Function Test
Time frame: 45 min
4 secondary outcomes
GRASSPGraded Redefined Assessment of Strength Sensibility and Prehension
Time frame: 60 min
Functional Independence Measures (FIM)
Time frame: 35 min
Spinal Cord Independence Measure (SCIM)
Time frame: 35 min
Client perception of treatment
Time frame: 15 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
- Rehabilitation Engineering LaboratoryLink provided by the sponsor.
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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.
Milos R Popovic, Ph.d 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 Phase 2 study testing FES Therapy and Conventional Occupational Therapy in people with Spinal Cord Injuries, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 25 Sep 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
REL Hand Function Test (time frame: 45 min). 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 25 Sep 2012.