Spinal Cord InjuryNCT00204100
Paraplegic Cycling: Improving Health After Spinal Cord Injury
A study testing Surface Functional Electrical Stimulation in people with Spinal Cord Injury, run by University of Glasgow at 2 sites in United Kingdom.
Trial summary
Surface electrical stimulation has for many years been widely used to retrain paralysed muscle and achieve the functions of standing and stepping. Recently a number of centres have used electrical stimulation of the leg muscles to achieve cycling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Surface Functional Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2003to May 2005
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Complete spinal cord lesion between T3-T12, of at least 1 year duration. Age between 18-65 years No significant medical or psychiatric complications (assessed by clinician). Sufficient range of motion at the joints (assessed by therapist). No excessive spasticity (assessed by therapist). Bone density in necks of femora and upper tibias > 40 - 60 mg/cm3. Willing to attend the clinic and to exercise at home according to the training programme. Having space at home to set up the tricycle ergometer for frequent use.
Who cannot join
- Bone density in necks of femora and upper tibias < 40 mg/cm3. Unable to transfer safely between wheelchair and tricycle.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Glasgow
Glasgow, Lanarkshire, G12 8QQ
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Lanarkshire, G51 4TF
About this study
Official title: The Development of Systems for Paraplegic Cycling: Improving Health After Spinal Cord Injury
Surface electrical stimulation has for many years been widely used to retrain paralysed muscle and achieve the functions of standing and stepping. Recently a number of centres have used electrical stimulation of the leg muscles to achieve cycling. During cycling the quadriceps and hamstring muscles (thigh muscles) (and sometimes also the gluteal (buttocks) muscles) are stimulated to obtain a cycling motion. Stimulation is applied using adhesive electrodes placed on the surface of the skin. This form of exercise is known as FES-cycling (FES = Functional Electrical Stimulation).
We have recently carried out a pilot study which investigated the feasibility of lower-limb cycling using electrical stimulation. Cycling is accomplished using a standard recumbent tricycle, which is adapted for the purpose of FES cycling. Three people with a complete spinal cord lesion at level T7-T10 took part in the pilot study. The subjects are now able to cycle continuously and reliably on a tricycle mounted on a cycle trainer for periods of up to 1 hour. The subjects are also able to cycle outside for distances of up to 3 km.
Read more
The purpose of the new study is threefold: (i) We wish to develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification; (ii) The subjects recruited for the project will carry out a progressive, high-intensity cycle-training programme. In Glasgow, 5 paraplegic subjects shall complete the training programme, which will be based at their homes. This will allow us to fully assess the feasibility of recreational FES-cycling, by measuring the power which can be sustained during long periods of cycling, and to measure the impact of the training regime on their quality of life; (iii) We will determine whether the training regime leads to significant improvements in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in the likelihood of the development of pressure sores and fractures.
We hope that this type of exercise will lead to general improvements in the fitness of people who might use the system in future.
Read the detailed description
Background:
Spinal cord injury (SCI) prevents normal leg exercise which leads to secondary complications, including cardiopulmonary deconditioning, a high incidence of pressure sores, and bone demineralisation. Wheelchair sports do not raise fitness to the level of sedentary non-injured people but it has been shown that cycling via functional electrical stimulation, "FES-cycling", can. Previous studies have been clinic-based; this limits the exercise time and is inappropriate for widespread use. We propose to show that home-based FES-tricycling can be a recreation, and can also lead to significant health benefits.
We will train subjects at home more intensively than in previous studies, to see whether they can cycle useful distances. The effects of this training will be systematically assessed in a Health Study, which will: (i) regularly monitor cardiopulmonary fitness; (ii) make regular tissue measurements related to pressure sore susceptibility, and (iii) measure the effect on bone density. These health measurements will be made at the collaborating clinical centres, i.e. for Glasgow, this will be at the Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital. We will also document the mobile recumbent tricycle system as a design specification, in preparation for commercialisation.
The project will be based around three centres, in London, Glasgow and Nottwil, and brings together an interdisciplinary team of engineers, exercise scientists, therapists and clinicians.
Aims:
Engineering Development. To develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification.
Training for Recreation. To carry out a progressive, high-intensity FES cycle-training programme. 15 paraplegic subjects (5 at each centre) shall complete the training programme, which is based at their homes. To assess the feasibility of recreational FES-cycling, by measuring the power which can be sustained during long periods of cycling, and to measure the impact of the training regime on their quality of life.
Health and Fitness Study. To assess whether the training regime leads to significant improvements in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in the likelihood of the development of pressure sores and fractures.
- Conditions
- Spinal Cord Injury
- Being tested
- Surface Functional Electrical Stimulation
- Keywords
- paraplegia, spinal cord injury, functional electrical stimulation, cycling, exercise, cardiopulmonary fitness
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface Functional Electrical StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cardiopulmonary fitness
Secondary outcomes (7)
changes in:
bone mineral density
muscle bulk
peak muscle force
soft tissue distribution
seating pressure
re-oxygenation after ischaemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Study completionMay 2005
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth J Hunt, BSc, PhD, DSc, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204100
- Sponsor's protocol ID
- FEScyclingGlasgow
- Other IDs
- UK EPSRC: GR/R92462/01
- Status last verified
- May 2005
- First submitted
- 12 Sep 2005
- Last updated
- 12 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Systems for Paraplegic Cycling: Improving Health After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00204100
- Acronym / sponsor ID
- FEScyclingGlasgow
- Conditions
- Spinal Cord Injury
- Keywords
- paraplegia, spinal cord injury, functional electrical stimulation, cycling, exercise, cardiopulmonary fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- May 2005
- First posted
- 20 Sep 2005 (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.
Surface electrical stimulation has for many years been widely used to retrain paralysed muscle and achieve the functions of standing and stepping. Recently a number of centres have used electrical stimulation of the leg muscles to achieve cycling. During cycling the quadriceps and hamstring muscles (thigh muscles) (and sometimes also the gluteal (buttocks) muscles) are stimulated to obtain a cycling motion. Stimulation is applied using adhesive electrodes placed on the surface of the skin. This form of exercise is known as FES-cycling (FES = Functional Electrical Stimulation).
We have recently carried out a pilot study which investigated the feasibility of lower-limb cycling using electrical stimulation. Cycling is accomplished using a standard recumbent tricycle, which is adapted for the purpose of FES cycling. Three people with a complete spinal cord lesion at level T7-T10 took part in the pilot study. The subjects are now able to cycle continuously and reliably on a tricycle mounted on a cycle trainer for periods of up to 1 hour. The subjects are also able to cycle outside for distances of up to 3 km.
The purpose of the new study is threefold: (i) We wish to develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification; (ii) The subjects recruited for the project will carry out a progressive, high-intensity cycle-training programme. In Glasgow, 5 paraplegic subjects shall complete the training programme, which will be based at their homes. This will allow us to fully assess the feasibility of recreational FES-cycling, by measuring the power which can be sustained during long periods of cycling, and to measure the impact of the training regime on their quality of life; (iii) We will determine whether the training regime leads to significant improvements in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in the likelihood of the development of pressure sores and fractures.
We hope that this type of exercise will lead to general improvements in the fitness of people who might use the system in future.
Detailed description
Background:
Spinal cord injury (SCI) prevents normal leg exercise which leads to secondary complications, including cardiopulmonary deconditioning, a high incidence of pressure sores, and bone demineralisation. Wheelchair sports do not raise fitness to the level of sedentary non-injured people but it has been shown that cycling via functional electrical stimulation, "FES-cycling", can. Previous studies have been clinic-based; this limits the exercise time and is inappropriate for widespread use. We propose to show that home-based FES-tricycling can be a recreation, and can also lead to significant health benefits.
We will train subjects at home more intensively than in previous studies, to see whether they can cycle useful distances. The effects of this training will be systematically assessed in a Health Study, which will: (i) regularly monitor cardiopulmonary fitness; (ii) make regular tissue measurements related to pressure sore susceptibility, and (iii) measure the effect on bone density. These health measurements will be made at the collaborating clinical centres, i.e. for Glasgow, this will be at the Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital. We will also document the mobile recumbent tricycle system as a design specification, in preparation for commercialisation.
The project will be based around three centres, in London, Glasgow and Nottwil, and brings together an interdisciplinary team of engineers, exercise scientists, therapists and clinicians.
Aims:
Engineering Development. To develop the equipment and methods for recreational cycling to the stage of a pre-commercial design specification.
Training for Recreation. To carry out a progressive, high-intensity FES cycle-training programme. 15 paraplegic subjects (5 at each centre) shall complete the training programme, which is based at their homes. To assess the feasibility of recreational FES-cycling, by measuring the power which can be sustained during long periods of cycling, and to measure the impact of the training regime on their quality of life.
Health and Fitness Study. To assess whether the training regime leads to significant improvements in cardiopulmonary fitness, and therefore lower risk of heart disease, and to reductions in the likelihood of the development of pressure sores and fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Complete spinal cord lesion between T3-T12, of at least 1 year duration. Age between 18-65 years No significant medical or psychiatric complications (assessed by clinician). Sufficient range of motion at the joints (assessed by therapist). No excessive spasticity (assessed by therapist). Bone density in necks of femora and upper tibias > 40 - 60 mg/cm3. Willing to attend the clinic and to exercise at home according to the training programme. Having space at home to set up the tricycle ergometer for frequent use.
Key exclusion criteria (1 listed)
- Bone density in necks of femora and upper tibias < 40 mg/cm3. Unable to transfer safely between wheelchair and tricycle.
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 |
|---|---|---|
| Surface Functional Electrical Stimulation | Device | – |
Primary outcome
changes in cardiopulmonary fitness
7 secondary outcomes
changes in:
bone mineral density
muscle bulk
peak muscle force
soft tissue distribution
seating pressure
re-oxygenation after ischaemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
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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.
Kenneth J Hunt, BSc, PhD, DSc principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface Functional Electrical Stimulation in people with Spinal Cord Injury, run by University of Glasgow at 2 sites in United Kingdom.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
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?
changes in cardiopulmonary fitness. 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 12 Oct 2006.