Spinal Cord InjuriesNCT00221117
Benefits of Applying Neuroprosthesis to Improve Grasping and Reaching in Spinal Cord Injury Patients
A study testing Neuroprosthesis-FES Therapy and Conventional Ocupational Therapy (COT) in people with Spinal Cord Injuries, run by Toronto Rehabilitation Institute.
Trial summary
Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate… 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?
- Neuroprosthesis-FES Therapy and Conventional Ocupational Therapy (COT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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(incomplete)
- participants will be recruited during the first six months post-SCI.
Who cannot join
- uncontrolled hypertension
- susceptibility to autonomic dysreflexia
- pressure ulcer
- cardiac pacemakers
- skin rush
About this study
Official title: Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients
Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.
Read the detailed description
The main objective of this study is to determine the effectiveness of a new treatment regime that uses a neuroprosthesis for the improvement and recovery of grasping functions in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients with hemiplegic arm in the recovery of reaching and grasping 1, and our preliminary work indicates that this may also be the case with SCI patients 3. Further, aside from the potential of promoting voluntary grasp in SCI patients, this novel therapeutic approach may also impact the way service is currently delivered in SCI rehabilitation settings.
A neuroprosthesis for grasping is a device that can improve or restore the grasping, holding, and releasing functions in persons with SCI 2, 3. The neuroprosthesis applies functional electrical stimulation (FES) to artificially generate a muscle contraction by applying short current pulses to motor nerves innervating muscles. FES can be applied to individuals with incomplete SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner 4. FES was originally envisioned as an intervention that was 'permanent' in nature. In other words, an individual had to wear/use an FES orthotic device at all times if s/he wanted to generate the function that was impaired by SCI 4. Our application of the neuroprosthesis for grasping in this proposal presents a departure from this standard and established approach of FES application. Rather than having people be dependent on the neuroprosthesis to perform their activities of daily living (ADL), we plan to use the neuroprosthesis for grasping as a short-term intervention that will help SCI individuals recover voluntary grasping function. Hence, we believe that those participants who undergo our FES therapy with the neuroprosthesis should be able to perform grasping functions without its use once the treatment program is completed.
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 3, 5, 6. 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 incomplete SCI. Since 1999, the Co-PI of this application, Dr. Milos Popovic and Dejan Popovic's team from the University of Belgrade have reported anecdotal evidence that some C5 to C7 SCI individuals who were unable to voluntarily grasp, were later able to do so after intensive training with a neuroprosthesis for grasping 2, 7, 8, 9. They observed that approximately 20 to 25% of the individuals who trained with the FES systems were able to grasp without the assistance of the neuroprosthesis once the systems were removed. Although this evidence has been presented in several peer-reviewed publications, there have been no comprehensive studies to date that have investigated the long-term effects of FES treatment on recovery of the voluntary grasping function in persons with SCI. Consequently, this study seeks to 1) investigate whether a series of orchestrated FES therapies can be applied to re-train/improve voluntary grasping function in acute SCI individuals, and; 2) to determine whether this therapy will yield better results than conventional occupational therapy. Specifically, we will recruit participants who have C5 to C7 incomplete SCI. These individuals typically can generate weak wrist extension but can neither flex, extend, abduct or adduct the fingers, nor flex, extend, abduct or adduct the thumb. Our therapy will be used to help these individuals recover some or all of these functions.
- Conditions
- Spinal Cord Injuries
- Being tested
- Neuroprosthesis-FES Therapy, Conventional Ocupational Therapy (COT)
- 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.
Neuroprosthesis-FES TherapyDevice
Also called Neuroprosthesis
The Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia 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 grasp , and holds a number of advantages over the other existing neuroprostheses.
Conventional Ocupational Therapy (COT)Other
Also called Conventional Occupational Therapy (COT)
Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: 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 |
|---|---|---|
| Conventional Occupational Therapy (COT) | Active comparator | Conventional Occupational Therapy pertaining to hand function represents the current best practice activities against which the FET was compared. The COT included the following: (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 was neither FES nor FET, but electro muscular stimulation); (f) practice of activities of daily living (ADLs) including self-care where the upper extremities were used as appropriate; and (g) caregiver training. Receives: Other: Conventional Ocupational Therapy (COT) |
| Neuroprosthesis-FES Therapy | Experimental | The FES Therapy began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes. Receives: Device: Neuroprosthesis-FES Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
Functional Independent Measure was employed to measure the degree of disability for daily self care. It capture data on self-care, sphincter management, transfers,locomotion,communication,and social cognition.The scale is divided according to no helper category (level 6 and 7) where no other person is required to help with the activity and a hel;per category(level 1 through 5)where the patient needs minimal to total assistance from another person to accomplish the activity Score range from 18-126. Higher values represent a better outcome.
Measured: 35 min
Secondary outcomes (2)
Rehabilitation Engineering Laboratory Hand Function Test(REL Test)
The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) evaluates gross motor function of unilateral grasp (also referred to as the Rehabilitation Engineering Laboratory Hand Function Test). Hand functions that are assessed with TRI-HFT include the following: lateral or pulp pinch and palmar grasp.Score range from 0-70. Higher values represent a better outcome.
Measured: 45 min
Spinal Cord Independence Measure (SCIM).
Score range from 0-100. Higher score represent a better outcome.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Milos Popovic, Toronto Rehabilitation Institute
- Investigators
- Milos Popovic, Ph.D, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221117
- Sponsor's protocol ID
- TRI REB #02-032
- Status last verified
- Jun 2018
- First submitted
- 14 Sep 2005
- Last updated
- 24 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared , mean results of the study have been published in the peer reviewed paper.
Publications
Popovic MR, Curt A, Keller T, Dietz V. Functional electrical stimulation for grasping and walking: indications and limitations. Spinal Cord. 2001 Aug;39(8):403-12. doi: 10.1038/sj.sc.3101191.
PubMed 11512070Kapadia NM, Bagher S, Popovic MR. Influence of different rehabilitation therapy models on patient outcomes: hand function therapy in individuals with incomplete SCI. J Spinal Cord Med. 2014 Nov;37(6):734-43. doi: 10.1179/2045772314Y.0000000203. Epub 2014 Jun 26.
PubMed 24968955
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprosthesis for Improving Grasping Function in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT00221117
- Acronym / sponsor ID
- TRI REB #02-032
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Christopher Reeve Paralysis Foundation, The Physicians' Services Incorporated Foundation
- Study start
- Aug 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Functional electrical stimulation is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing.The study is designed to evaluate the effectiveness and long term benefits of applying functional electrical simulation during early rehabilitation to improve grasping function in persons who have suffered a spinal cord injury. By using functional electrical stimulation,these patients could potentially improve their grasping function.
Detailed description
The main objective of this study is to determine the effectiveness of a new treatment regime that uses a neuroprosthesis for the improvement and recovery of grasping functions in persons with spinal cord injuries (SCI). This treatment has been shown to be useful for stroke patients with hemiplegic arm in the recovery of reaching and grasping 1, and our preliminary work indicates that this may also be the case with SCI patients 3. Further, aside from the potential of promoting voluntary grasp in SCI patients, this novel therapeutic approach may also impact the way service is currently delivered in SCI rehabilitation settings.
A neuroprosthesis for grasping is a device that can improve or restore the grasping, holding, and releasing functions in persons with SCI 2, 3. The neuroprosthesis applies functional electrical stimulation (FES) to artificially generate a muscle contraction by applying short current pulses to motor nerves innervating muscles. FES can be applied to individuals with incomplete SCI to help them restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner 4. FES was originally envisioned as an intervention that was 'permanent' in nature. In other words, an individual had to wear/use an FES orthotic device at all times if s/he wanted to generate the function that was impaired by SCI 4. Our application of the neuroprosthesis for grasping in this proposal presents a departure from this standard and established approach of FES application. Rather than having people be dependent on the neuroprosthesis to perform their activities of daily living (ADL), we plan to use the neuroprosthesis for grasping as a short-term intervention that will help SCI individuals recover voluntary grasping function. Hence, we believe that those participants who undergo our FES therapy with the neuroprosthesis should be able to perform grasping functions without its use once the treatment program is completed.
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 3, 5, 6. 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 incomplete SCI. Since 1999, the Co-PI of this application, Dr. Milos Popovic and Dejan Popovic's team from the University of Belgrade have reported anecdotal evidence that some C5 to C7 SCI individuals who were unable to voluntarily grasp, were later able to do so after intensive training with a neuroprosthesis for grasping 2, 7, 8, 9. They observed that approximately 20 to 25% of the individuals who trained with the FES systems were able to grasp without the assistance of the neuroprosthesis once the systems were removed. Although this evidence has been presented in several peer-reviewed publications, there have been no comprehensive studies to date that have investigated the long-term effects of FES treatment on recovery of the voluntary grasping function in persons with SCI. Consequently, this study seeks to 1) investigate whether a series of orchestrated FES therapies can be applied to re-train/improve voluntary grasping function in acute SCI individuals, and; 2) to determine whether this therapy will yield better results than conventional occupational therapy. Specifically, we will recruit participants who have C5 to C7 incomplete SCI. These individuals typically can generate weak wrist extension but can neither flex, extend, abduct or adduct the fingers, nor flex, extend, abduct or adduct the thumb. Our therapy will be used to help these individuals recover some or all of these functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Occupational Therapy (COT) | Active comparator | Other: Conventional Ocupational Therapy (COT)Conventional Occupational Therapy pertaining to hand function represents the current best practice activities against which the FET was compared. The COT included the following: (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 was neither FES nor FET, but electro muscular stimulation); (f) practice of activities of daily living (ADLs) including self-care where the upper extremities were used as appropriate; and (g) caregiver training. |
| Neuroprosthesis-FES Therapy | Experimental | Device: Neuroprosthesis-FES TherapyThe FES Therapy began by designing stimulation protocols to generate power (circular grip and lateral pinch) and precision (opposition with 2 and 3 fingers) grasps on demand. The stimulation sequence (protocol) for power and precision grasps was developed for each patient individually using the Compex Motion electric stimulator. Compex Motion is a fully programmable transcutaneous (surface) stimulator that uses self-adhesive surface electrodes. |
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(incomplete)
- participants will be recruited during the first six months post-SCI.
Key exclusion criteria (5 listed)
- uncontrolled hypertension
- susceptibility to autonomic dysreflexia
- pressure ulcer
- cardiac pacemakers
- skin rush
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 |
|---|---|---|
| Neuroprosthesis-FES TherapyAlso: NeuroprosthesisThe Compex Motion neuroprostesis, developed by Drs. R. Popovic and Thierry Keller,and company Compex SA, ia 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 grasp , and holds a number of advantages over the other existing neuroprostheses. | Device | Neuroprosthesis-FES Therapy |
| Conventional Ocupational Therapy (COT)Also: Conventional Occupational Therapy (COT)Conventional occupational therapy pertaining to hand function represents control activities against which the FES therapy was assessed. The conventional occupational therapy included: 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 (COT) |
Primary outcome
Functional Independence Measure (FIM)
Time frame: 35 min
Functional Independent Measure was employed to measure the degree of disability for daily self care. It capture data on self-care, sphincter management, transfers,locomotion,communication,and social cognition.The scale is divided according to no helper category (level 6 and 7) where no other person is required to help with the activity and a hel;per category(level 1 through 5)where the patient needs minimal to total assistance from another person to accomplish the activity Score range from 18-126. Higher values represent a better outcome.
2 secondary outcomes
Rehabilitation Engineering Laboratory Hand Function Test(REL Test)
Time frame: 45 min
Spinal Cord Independence Measure (SCIM).
Time frame: 30 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11512070Popovic MR, Curt A, Keller T, Dietz V. Functional electrical stimulation for grasping and walking: indications and limitations. Spinal Cord. 2001 Aug;39(8):403-12. doi: 10.1038/sj.sc.3101191.
- Derived from this study: PubMed 24968955Kapadia NM, Bagher S, Popovic MR. Influence of different rehabilitation therapy models on patient outcomes: hand function therapy in individuals with incomplete SCI. J Spinal Cord Med. 2014 Nov;37(6):734-43. doi: 10.1179/2045772314Y.0000000203. Epub 2014 Jun 26.
- Rehabilitation Engineering LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared , mean results of the study have been published in the peer reviewed paper.
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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 Popovic, Ph.D principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Neuroprosthesis-FES Therapy and Conventional Ocupational Therapy (COT) in people with Spinal Cord Injuries, run by Toronto Rehabilitation Institute.
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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (FIM) (time frame: 35 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221117, which also lists 2 linked publications.
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 24 Jul 2018.