Spinal Cord InjuryNCT02554058
Combined Tactile and Proprioception Training After Spinal Cord Injury
A study testing Cycling and Mechanical stimulation in people with Spinal Cord Injury, run by University of Manitoba at 1 site in Canada.
Trial summary
A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve… 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 and Mechanical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Dec 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant should have experienced a traumatic spinal cord injury
- American Spinal Injury Association (ASIA) class C or D
- Between 18 and 65 years
- At least 12 months post- injury to ensure stability of the patient's neurological condition
- Should be able to walk 10 meters or more with or without assistance (use of braces or walking aids or parallel bars or moderate assistance of one person)
- Should have range of motion in the lower limb joint sufficient to allow the cycling exercise
- Discharged from all rehabilitation.
Who cannot join
- Impaired mental capacity
- Any medical contradiction to cycling training
- Degenerative spinal disorder
- Significant diagnosed osteoporosis
- Excessive spasticity in the legs as measured by a score of more than 3 on the Modified Ashworth Scale or any spasticity that limits the possibility of cycling exercise or walking
- Obstructive and/or restrictive pulmonary disease
- Severe spinal and Lower Limb deformities
- Decubitus ulcer in the area in contact with the bike and bike's bed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Effects of Training With a Novel Rehabilitation Bike on the Functional Recovery and Corticospinal Plasticity in Individuals With Incomplete Spinal Cord Injuries
A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve muscle atrophy in astronauts in zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict that the combination of mechanical stimulation with cycling may be similar enough to walking over ground to lead to gains in balance and mobility. The present study will evaluate the therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal pathways in patients with incomplete spinal cord injuries.
Read the detailed description
INTRODUCTION:
Individuals with spinal cord injuries (SCI) experience balance impairments and limitations in walking. Newer research demonstrates that even after several years individuals with incomplete SCIs can make significant gains in function when they are engaged in targeted physical activity. Previous studies using functional electrical stimulation and locomotion training report reduced spasticity and reflex control, increased electromyography activity during stepping, and increased thigh muscles mass. However, these methods and instruments are bulky, expensive, need technical maintenance, and must be used in a clinical setting. A novel rehabilitation bicycle that uses simultaneous stimulation of plantar mechanoreceptors and hip joint proprioceptors was developed in the department of Biomedical Engineering of University of Manitoba. An advantage of this device is that patients can use it at home and with minimal assistance. Five patients completed initial pilot testing and exhibited an overall improvement on the Berg Balance Scale. Presently, the effect of rehabilitation bike training on the plasticity of the spinal and corticospinal neuronal circuitry and consequently its effects on the functional walking capacity are unclear.
OBJECTIVES:
The purpose of the present study is to evaluate the effect of the rehabilitation bike on corticospinal and spinal plasticity, and functional walking and balance in incomplete SCI individuals.
METHODS:
Ten individuals with chronic incomplete SCI will participate in this study. The protocol will include 30 minute training sessions, three times/week, for 8 weeks. The study design will be a before-after clinical trial with two baseline assessments prior to training. Post-training evaluation after two weeks will be done and there will be a post-training follow-up assessment after two weeks.
Evaluations of functional recovery and independence include: Six -Minute and Ten-Meter Walk Tests, Walking index for spinal cord injury(WISCI II). The Berg Balance Scale(BBS) will be conducted to assess balance. Results will be compared before and after training. H-reflex and motor evoked potential (using transcranial magnetic stimulation ,TMS) will also be measured before and after cycling training to assess the plasticity at the level of the spine and in the corticospinal pathways respectively.
ANTICIPATED RESULTS:
Compared to locomotion training with treadmills and robotic devices, using the rehabilitation bike is affordable and patients are able to use it independently at home, without the help of a physical therapist or a caregiver. Results of this study will clarify the possible positive effect of training with the rehabilitation bike on the corticospinal reorganization as well as training effects on the functional recovery of balance and walking. If the findings from the present study are consistent with the initial pilot data, then it will provide incomplete SCI patients and their therapists with a new option for rehabilitation that is feasible and cost-effective. Considering the relatively high incidence of SCI in Manitoba, the findings from this study will directly improve quality of life for Manitobans and Canadians living with spinal cord injuries.
- Conditions
- Spinal Cord Injury
- Being tested
- Cycling and Mechanical stimulation
- Keywords
- Spinal cord injury, rehabilitation, cycling
- 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 and Mechanical stimulationDevice
Cycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cycling and Mechanical stimulation | Experimental | Cycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks. Receives: Device: Cycling and Mechanical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs)
MEPs in tibialis anterior muscle using single pulse transcranial magnetic stimulation will be measure.The average of 4 trials in different stimulation intensity will be calculated.
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in Peak-to-peak amplitude of the H-reflex
Average of 10 peak to peak amplitudes of the H-reflex in soleus muscle with stimulation frequencies of 0.1, 0.2, 0.5 and 10 Hz.
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Secondary outcomes (4)
Change in Berg Balance Scale score(BBS)
BBS is a 14-item scale to assess balance.Total Score is 56 points.
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in 10 meter walk test time
Duration of walking for 10 meters.
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in 2 minute walk test score
The distance walked within 6 minutes.
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in Walking index for spinal cord injury (WISCI II) score
WISCI II is an index; it scores the ability of an individual to walk after SCI after a 10 meters of walking. The index score range is 0-20 from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons
Measured: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 2016
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.
- More trials run by University of ManitobaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cheryl Glazebrook, University of Manitoba
- Investigators
- Chery Glazebrook, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554058
- Sponsor's protocol ID
- Bannatyne2010:157
- Status last verified
- May 2017
- First submitted
- 5 Sep 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Effects of Training With a Novel Rehabilitation Bike on the Functional Recovery and Corticospinal Plasticity in Individuals With Incomplete Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT02554058
- Acronym / sponsor ID
- Bannatyne2010:157
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, rehabilitation, cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Sep 2015 (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.
A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve muscle atrophy in astronauts in zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict that the combination of mechanical stimulation with cycling may be similar enough to walking over ground to lead to gains in balance and mobility. The present study will evaluate the therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal pathways in patients with incomplete spinal cord injuries.
Detailed description
INTRODUCTION:
Individuals with spinal cord injuries (SCI) experience balance impairments and limitations in walking. Newer research demonstrates that even after several years individuals with incomplete SCIs can make significant gains in function when they are engaged in targeted physical activity. Previous studies using functional electrical stimulation and locomotion training report reduced spasticity and reflex control, increased electromyography activity during stepping, and increased thigh muscles mass. However, these methods and instruments are bulky, expensive, need technical maintenance, and must be used in a clinical setting. A novel rehabilitation bicycle that uses simultaneous stimulation of plantar mechanoreceptors and hip joint proprioceptors was developed in the department of Biomedical Engineering of University of Manitoba. An advantage of this device is that patients can use it at home and with minimal assistance. Five patients completed initial pilot testing and exhibited an overall improvement on the Berg Balance Scale. Presently, the effect of rehabilitation bike training on the plasticity of the spinal and corticospinal neuronal circuitry and consequently its effects on the functional walking capacity are unclear.
OBJECTIVES:
The purpose of the present study is to evaluate the effect of the rehabilitation bike on corticospinal and spinal plasticity, and functional walking and balance in incomplete SCI individuals.
METHODS:
Ten individuals with chronic incomplete SCI will participate in this study. The protocol will include 30 minute training sessions, three times/week, for 8 weeks. The study design will be a before-after clinical trial with two baseline assessments prior to training. Post-training evaluation after two weeks will be done and there will be a post-training follow-up assessment after two weeks.
Evaluations of functional recovery and independence include: Six -Minute and Ten-Meter Walk Tests, Walking index for spinal cord injury(WISCI II). The Berg Balance Scale(BBS) will be conducted to assess balance. Results will be compared before and after training. H-reflex and motor evoked potential (using transcranial magnetic stimulation ,TMS) will also be measured before and after cycling training to assess the plasticity at the level of the spine and in the corticospinal pathways respectively.
ANTICIPATED RESULTS:
Compared to locomotion training with treadmills and robotic devices, using the rehabilitation bike is affordable and patients are able to use it independently at home, without the help of a physical therapist or a caregiver. Results of this study will clarify the possible positive effect of training with the rehabilitation bike on the corticospinal reorganization as well as training effects on the functional recovery of balance and walking. If the findings from the present study are consistent with the initial pilot data, then it will provide incomplete SCI patients and their therapists with a new option for rehabilitation that is feasible and cost-effective. Considering the relatively high incidence of SCI in Manitoba, the findings from this study will directly improve quality of life for Manitobans and Canadians living with spinal cord injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycling and Mechanical stimulation | Experimental | Device: Cycling and Mechanical stimulationCycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant should have experienced a traumatic spinal cord injury
- American Spinal Injury Association (ASIA) class C or D
- Between 18 and 65 years
- At least 12 months post- injury to ensure stability of the patient's neurological condition
- Should be able to walk 10 meters or more with or without assistance (use of braces or walking aids or parallel bars or moderate assistance of one person)
Key exclusion criteria (8 listed)
- Impaired mental capacity
- Any medical contradiction to cycling training
- Degenerative spinal disorder
- Significant diagnosed osteoporosis
- Excessive spasticity in the legs as measured by a score of more than 3 on the Modified Ashworth Scale or any spasticity that limits the possibility of cycling exercise or walking
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 and Mechanical stimulationCycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks. | Device | Cycling and Mechanical stimulation |
Primary outcome
Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs)
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
MEPs in tibialis anterior muscle using single pulse transcranial magnetic stimulation will be measure.The average of 4 trials in different stimulation intensity will be calculated.
Change in Peak-to-peak amplitude of the H-reflex
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Average of 10 peak to peak amplitudes of the H-reflex in soleus muscle with stimulation frequencies of 0.1, 0.2, 0.5 and 10 Hz.
4 secondary outcomes
Change in Berg Balance Scale score(BBS)
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in 10 meter walk test time
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in 2 minute walk test score
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
Change in Walking index for spinal cord injury (WISCI II) score
Time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session
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 9 May 2017.
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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.
Chery Glazebrook principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling and Mechanical stimulation in people with Spinal Cord Injury, run by University of Manitoba 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 8 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 9 May 2017. 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 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?
Change in Peak-to-peak amplitude of the motor evoked potentials (MEPs) (time frame: 2 weeks prior to first baseline measurement, prior to first training session, after 4 weeks and 8 weeks of training, 2 weeks after the last training session). The study lists 2 primary outcomes in all. 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 9 May 2017.