Spinal Cord InjuryPhase 2/3NCT01244594
The Effects of Two Functional Electrical Stimulation Cycling Paradigms
A Phase 2/3 study testing Cycling with functional electrical stimulation in people with Spinal Cord Injury, run by Thomas Jefferson University at 3 sites in United States.
Trial summary
Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. 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?
- Cycling with functional electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to Oct 2013
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cervical or thoracic SCI of greater than 6 months duration
- American Spinal Injury Association Impairment Scale (AIS) levels A (motor and sensory complete) or B (motor complete)
- Intact lower motor neurons to the quadriceps, hamstrings, and gluteal muscles
Who cannot join
- History of renal or bladder stones or renal impairment
- Presence of conditions that require chronic steroids
- Symptomatic or known cardiac disease
- Pulmonary disease limiting exercise tolerance
- Ventilator dependency
- Implanted devices that may be adversely affected by the FES system
Show all 18Show fewer
- Lower extremity fragility fractures in the previous 3 months
- Severe spasticity in legs
- Presence of a Grade 2 or higher pressure ulcer
- Severely limited range of joint motion
- Heterotopic ossification of joints in the lower extremities
- Uncontrolled autonomic dysreflexia
- Dislocation of one or both hips
- Pregnancy or plans to become pregnant during the study
- Post menopausal, if female
- Current seizure disorder
- Participation in activities involving electrical stimulation or activity based therapy within the past 3 months
- Participation in a neuroregenerative intervention within the past 12 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Magee Rehabilitation Hospital
Philadelphia, Pennsylvania, 19102
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Background:
People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many have been cycling for many years. This new technique may allow them to obtain more benefits than what they currently are receiving from FES cycling. In addition, it is important to maintain overall bone, muscle and cardiovascular health so that people with SCI are health and ready when spinal cord regeneration becomes clinically available.
- Conditions
- Spinal Cord Injury
- Being tested
- Cycling with functional electrical stimulation
- Keywords
- Spinal Cord Injury, Cycling, Functional Electrical Stimulation
- 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.
Cycling with functional electrical stimulationOther
Subjects will cycle with functional electrical stimulation for one hour, 3 times per week at Magee Rehab's outpatient center. Subjects will cycle for a total of 26 weeks (6 months).
| Study group | Role | What they receive |
|---|---|---|
| High cadence, low resistance | Experimental | Subjects in this arm will cycle with functional electrical stimulation at a higher cadence (speed) and a lower resistance. Receives: Other: Cycling with functional electrical stimulation |
| Low cadence, high resistance | Experimental | Subjects in this arm will cycle with functional electrical stimulation at a lower cadence (speed) and a higher resistance. Receives: Other: Cycling with functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density and bone microarchitecture
Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
Measured: Baseline
Bone density and bone microarchitecture
Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
Measured: 6 months
Muscle volume
Muscle volume is assessed using MRI
Measured: Baseline
Muscle volume
Muscle volume is assessed using MRI
Measured: 6 months
Secondary outcomes (9)
Muscle strength
Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
Measured: Baseline
Muscle strength
Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
Measured: 3 months
Muscle strength
Muscle strength is assessed by stimulating the muscle using a max twitch technique and measuring the isometric force output on a dynamometer.
Measured: 6 months
Bone markers
Bone markers are assessed through blood and urine analysis.
Measured: baseline
Bone markers
Bone markers are assessed through blood and urine analysis.
Measured: 3 months
Bone markers
Bone markers are assessed through blood and urine analysis.
Measured: 6 months
Fat free soft tissue
Fat free mass is assessed using a bioimpedance monitor.
Measured: baseline
Fat free soft tissue
Fat free mass is assessed using a bioimpedance monitor.
Measured: 3 months
Fat free soft tissue
Fat free mass is assessed using a bioimpedance monitor.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Magee Rehabilitation Hospital, Temple University, University of Delaware
- Responsible party
- Sponsor
- Investigators
- Therese E Johnston, PT, PhD, MBA, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244594
- Sponsor's protocol ID
- 164600
- Status last verified
- Jan 2014
- First submitted
- 15 Nov 2010
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston TE, Marino RJ, Oleson CV, Schmidt-Read M, Leiby BE, Sendecki J, Singh H, Modlesky CM. Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1413-1422. doi: 10.1016/j.apmr.2015.11.014. Epub 2015 Dec 17.
PubMed 26705884
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Functional Electrical Stimulation Cycling Paradigms
- ClinicalTrials.gov ID
- NCT01244594
- Acronym / sponsor ID
- 164600
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Cycling, Functional Electrical Stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation, Magee Rehabilitation Hospital, Temple University, University of Delaware
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Nov 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.
Background:
People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many have been cycling for many years. This new technique may allow them to obtain more benefits than what they currently are receiving from FES cycling. In addition, it is important to maintain overall bone, muscle and cardiovascular health so that people with SCI are health and ready when spinal cord regeneration becomes clinically available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High cadence, low resistance | Experimental | Other: Cycling with functional electrical stimulationSubjects in this arm will cycle with functional electrical stimulation at a higher cadence (speed) and a lower resistance. |
| Low cadence, high resistance | Experimental | Other: Cycling with functional electrical stimulationSubjects in this arm will cycle with functional electrical stimulation at a lower cadence (speed) and a higher resistance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cervical or thoracic SCI of greater than 6 months duration
- American Spinal Injury Association Impairment Scale (AIS) levels A (motor and sensory complete) or B (motor complete)
- Intact lower motor neurons to the quadriceps, hamstrings, and gluteal muscles
Key exclusion criteria (18 listed)
- History of renal or bladder stones or renal impairment
- Presence of conditions that require chronic steroids
- Symptomatic or known cardiac disease
- Pulmonary disease limiting exercise tolerance
- Ventilator dependency
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 |
|---|---|---|
| Cycling with functional electrical stimulationSubjects will cycle with functional electrical stimulation for one hour, 3 times per week at Magee Rehab's outpatient center. Subjects will cycle for a total of 26 weeks (6 months). | Other | High cadence, low resistance, Low cadence, high resistance |
Primary outcome
Bone density and bone microarchitecture
Time frame: Baseline
Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
Bone density and bone microarchitecture
Time frame: 6 months
Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
Muscle volume
Time frame: Baseline
Muscle volume is assessed using MRI
Muscle volume
Time frame: 6 months
Muscle volume is assessed using MRI
9 secondary outcomes
Muscle strength
Time frame: Baseline
Muscle strength
Time frame: 3 months
Muscle strength
Time frame: 6 months
Bone markers
Time frame: baseline
Bone markers
Time frame: 3 months
Bone markers
Time frame: 6 months
Fat free soft tissue
Time frame: baseline
Fat free soft tissue
Time frame: 3 months
Fat free soft tissue
Time frame: 6 months
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 8 Jan 2014.
- Derived from this study: PubMed 26705884Johnston TE, Marino RJ, Oleson CV, Schmidt-Read M, Leiby BE, Sendecki J, Singh H, Modlesky CM. Musculoskeletal Effects of 2 Functional Electrical Stimulation Cycling Paradigms Conducted at Different Cadences for People With Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1413-1422. doi: 10.1016/j.apmr.2015.11.014. Epub 2015 Dec 17.
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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.
Therese E Johnston, PT, PhD, MBA principal investigator
Thomas Jefferson University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cycling with functional electrical stimulation in people with Spinal Cord Injury, run by Thomas Jefferson University at 3 sites 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 3 inclusion and 18 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Bone density and bone microarchitecture (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT01244594, which also lists 1 linked publication.
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 8 Jan 2014.