Spinal Cord InjuryPhase 1/2NCT01479777
Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury
A Phase 1/2 study testing FES Stepping (RT600 from Restorative Therapies, INC.) in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- FES Stepping (RT600 from Restorative Therapies, INC.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Apr 2012
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, Female, age 18-65, all ethnic groups
- Spinal Cord Injury, traumatic and non-traumatic
- C1-T12 neurological level
- ASIA class A-D
- Chronic injury > 6 months from the injury
- Visible motor response to FES stimulation (visible muscle contraction evoked with electrical stimulation)
- Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- Subjects are able to comply with procedures and follow-up
Who cannot join
- Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- History of inability to tolerate electrical stimulation
- Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability
- Uncontrolled hypertension (resting systolic BP > 160mmHg or diastolic BP >100mmHg consistently)
- Presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps
- Unstable long bone fractures of the lower extremities
Show all 12Show fewer
- Presence of stage III or greater skin ulcerations that would preclude application of stimulating pads
- Malignancy
- History of epileptic seizures
- Women who are pregnant
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Fractures less than 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21205
About this study
Official title: FES Driven Stepping in Individuals With Spinal Cord Injury
The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.
Read the detailed description
Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).
- Conditions
- Spinal Cord Injury
- Being tested
- FES Stepping (RT600 from Restorative Therapies, INC.)
- Keywords
- Spinal Cord Injury, Functional electrical stimulation, Rehabilitation
- 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 Stepping (RT600 from Restorative Therapies, INC.)Device
Also called RT600 from Restorative Therapies, INC.
You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| FES Stepping | Experimental | For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping. Receives: Device: FES Stepping (RT600 from Restorative Therapies, INC.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome.
AIS Classificatrion:
A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5.
B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.
C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.
D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.
E = Normal: motor and sensory function are normal.
Measured: Baseline, 8 weeks
Secondary outcomes (6)
Change in Heart Rate
Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.
Measured: Baseline, 8 weeks
Change in Systolic Blood Pressure
Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.
Measured: Baseline, 8 weeks
Change in Diastolic Plood Pressure
Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.
Measured: Baseline, 8 weeks
Change in Rate of Perceived Exertion
Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters.
The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion.
Measured: Baseline, 8 weeks
Change in Vital Capacity
Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.
Measured: Baseline, 8 weeks
Change in Peak Cough Flow
Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Cristina L Sadowsky, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479777
- Sponsor's protocol ID
- NA_00016421
- Status last verified
- Sep 2014
- First submitted
- 15 Nov 2011
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FES Driven Stepping in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01479777
- Acronym / sponsor ID
- NA_00016421
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Functional electrical stimulation, Rehabilitation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Posted 15 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.
Detailed description
Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES Stepping | Experimental | Device: FES Stepping (RT600 from Restorative Therapies, INC.)For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male, Female, age 18-65, all ethnic groups
- Spinal Cord Injury, traumatic and non-traumatic
- C1-T12 neurological level
- ASIA class A-D
- Chronic injury > 6 months from the injury
Key exclusion criteria (12 listed)
- Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
- History of inability to tolerate electrical stimulation
- Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability
- Uncontrolled hypertension (resting systolic BP > 160mmHg or diastolic BP >100mmHg consistently)
- Presence of a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices other than baclofen pumps
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 Stepping (RT600 from Restorative Therapies, INC.)Also: RT600 from Restorative Therapies, INC.You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour. | Device | FES Stepping |
Primary outcome
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
Time frame: Baseline, 8 weeks
Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal.
6 secondary outcomes
Change in Heart Rate
Time frame: Baseline, 8 weeks
Change in Systolic Blood Pressure
Time frame: Baseline, 8 weeks
Change in Diastolic Plood Pressure
Time frame: Baseline, 8 weeks
Change in Rate of Perceived Exertion
Time frame: Baseline, 8 weeks
Change in Vital Capacity
Time frame: Baseline, 8 weeks
Change in Peak Cough Flow
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cristina L Sadowsky, MD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FES Stepping (RT600 from Restorative Therapies, INC.) in people with Spinal Cord Injury, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
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 8 inclusion and 12 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 15 Sep 2014. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 15 Sep 2014). 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?
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS) (time frame: Baseline, 8 weeks). 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 15 Sep 2014.