Spinal Cord InjuryNCT00204126
Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury
A study testing Treadmill with partial body weight support and Surface Functional Electrical Stimulation in people with Spinal Cord Injury, run by University of Glasgow at 2 sites in United Kingdom.
Trial summary
Treadmill therapy has the potential to improve the physical fitness and voluntary function of incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a rehabilitation strategy, evidence must be gathered to support its effectiveness. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Treadmill with partial body weight support and Surface Functional Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2005to Feb 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 16 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Satisfactory general medical examination
- Incomplete paraplegia or tetraplegia secondary to spinal cord lesion
- Previously discharged from hospital, following primary rehabilitation
- Capable of independent ambulation, with or without orthotic support
Who cannot join
- Female subjects should not be pregnant.
- No significant history of autonomic dysreflexia.
- No history of significant osteoporosis, or associated previous history of spontaneous lower-limb fracture. Bone density will be measured in the epiphyses of the tibia and femur of both legs using peripheral Quantitative Computed Tomography (pQCT).
- No history of coronary heart disease.
- No clinical features of significant cardio-respiratory impairment.
- Absence of hypertension.
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: Determination of Novel Methods of Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury
Treadmill therapy has the potential to improve the physical fitness and voluntary function of incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a rehabilitation strategy, evidence must be gathered to support its effectiveness. Present methods used to determine the efficacy of treadmill training do not provide accurate means of monitoring changes in physical fitness during the exercise, or to accurately measure the changes in voluntary muscle function which may occur during a training intervention.
We are therefore currently recruiting subjects for a study investigating the feasibility of new methods for monitoring improvements in physical fitness during walking on a treadmill. We also aim to develop methods for monitoring changes in voluntary muscle strength. The bone density of both legs will also be measured to determine if any improvement has occurred following training.
Read the detailed description
Treadmill therapy has the potential to improve the cardiopulmonary fitness, voluntary function, and lower limb bone density of incomplete spinal cord injury (SCI) patients. However, if it is to be offered clinically as a rehabilitation strategy then evidence must be gathered to support its effectiveness.
The efficacy of FES-assisted walking with incomplete SCI individuals, both overground and on a treadmill, has previously been assessed by monitoring walking speed, stride length, endurance, cadence, the physiological and oxygen cost, % body weight support (treadmill), and by performing observational gait analysis and manual muscle testing (1,2,3,4,5,6). However, these methods do not provide a means of measuring changes in fitness or for accurately monitoring improvements in voluntary muscle function.
At present appropriate methods for testing a person's cardiopulmonary fitness on a treadmill are lacking. Previously, incremental exercise tests have been carried out by maintaining a constant inclination and increasing the speed linearly.
However, if the speed is increased linearly it is likely that it will increase at too fast a pace. Therefore the test will become a measure of the subject's ability to move their legs quickly and/or efficiently enough, rather than metabolic factors. If a steep gradient is chosen as the constant inclination then a high initial metabolic cost will result, which will limit the test time. Another common method used is to maintain a constant speed while increasing the sine of the angle of inclination. The problem with this method of testing is that if too low a speed is selected then a very steep gradient results before the level of tolerance is reached, and if too high a speed is selected there is a high initial metabolic cost. These problems were addressed in a recent paper by Porszasz et al., 2003 (7). They demonstrated that by increasing walking speed linearly and treadmill gradient curvilinearly, a linear increase in work rate occurs with the subjects fatiguing at a moderate speed. If this protocol could be adapted for use with incomplete SCI patients it would provide an accurate means of testing changes in cardiopulmonary function which may result after treadmill training.
It has recently been recorded that dynamometry (rather than manual muscle scores) should be used to assess changes in voluntary function in incomplete SCI patients (8). Therefore we will employ this approach in this study. Following a spinal injury there is a rapid decline in bone mineral density which increases the risk of fracture following minor trauma. Therefore we will also measure the bone density at the epiphyses and shaft of the tibia and femur to determine if this form of training leads to changes in bone mineral density in this patient population.
By demonstrating that treadmill training can improve the cardiopulmonary fitness of individuals with incomplete SCI, their voluntary strength, and bone mineral density, it will help to provide the evidence that this form of rehabilitation is worthwhile.
By increasing cardiopulmonary fitness it will reduce their risk of developing cardiovascular disease, a major problem in this population due to their sedentary lifestyle. If it can be demonstrated to improve their voluntary function it would suggest that their quality of life and ability to carry out activities of daily living may also improve. Improving their bone density would consequently reduce their risk of fracture. Therefore the results of this study will contribute to the quest of trying to improve the overall health and functional ability of this patient population.
- Conditions
- Spinal Cord Injury
- Being tested
- Treadmill with partial body weight support, Surface Functional Electrical Stimulation
- Keywords
- exercise testing, treadmill, incomplete spinal cord injury, novel methods
- 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.
Treadmill with partial body weight supportDevice
Surface Functional Electrical StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
peak oxygen uptake
lactate threshold
oxygen uptake kinetics
Secondary outcomes (3)
torque during maximum voluntary contractions in leg muscles
central activation ratio of leg muscles
bone mineral density in tibia and femur
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 startFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT00204126
- Sponsor's protocol ID
- GUTreadmillSCI
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Publications
Granat M, Keating JF, Smith AC, Delargy M, Andrews BJ. The use of functional electrical stimulation to assist gait in patients with incomplete spinal cord injury. Disabil Rehabil. 1992 Apr-Jun;14(2):93-7. doi: 10.3109/09638289209167078.
PubMed 1600188Porszasz J, Casaburi R, Somfay A, Woodhouse LJ, Whipp BJ. A treadmill ramp protocol using simultaneous changes in speed and grade. Med Sci Sports Exerc. 2003 Sep;35(9):1596-603. doi: 10.1249/01.MSS.0000084593.56786.DA.
PubMed 12972882
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Novel Methods of Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00204126
- Acronym / sponsor ID
- GUTreadmillSCI
- Conditions
- Spinal Cord Injury
- Keywords
- exercise testing, treadmill, incomplete spinal cord injury, novel methods
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Feb 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.
Treadmill therapy has the potential to improve the physical fitness and voluntary function of incomplete-lesion spinal cord injured (SCI) patients. However, if it is to be offered as a rehabilitation strategy, evidence must be gathered to support its effectiveness. Present methods used to determine the efficacy of treadmill training do not provide accurate means of monitoring changes in physical fitness during the exercise, or to accurately measure the changes in voluntary muscle function which may occur during a training intervention.
We are therefore currently recruiting subjects for a study investigating the feasibility of new methods for monitoring improvements in physical fitness during walking on a treadmill. We also aim to develop methods for monitoring changes in voluntary muscle strength. The bone density of both legs will also be measured to determine if any improvement has occurred following training.
Detailed description
Treadmill therapy has the potential to improve the cardiopulmonary fitness, voluntary function, and lower limb bone density of incomplete spinal cord injury (SCI) patients. However, if it is to be offered clinically as a rehabilitation strategy then evidence must be gathered to support its effectiveness.
The efficacy of FES-assisted walking with incomplete SCI individuals, both overground and on a treadmill, has previously been assessed by monitoring walking speed, stride length, endurance, cadence, the physiological and oxygen cost, % body weight support (treadmill), and by performing observational gait analysis and manual muscle testing (1,2,3,4,5,6). However, these methods do not provide a means of measuring changes in fitness or for accurately monitoring improvements in voluntary muscle function.
At present appropriate methods for testing a person's cardiopulmonary fitness on a treadmill are lacking. Previously, incremental exercise tests have been carried out by maintaining a constant inclination and increasing the speed linearly.
However, if the speed is increased linearly it is likely that it will increase at too fast a pace. Therefore the test will become a measure of the subject's ability to move their legs quickly and/or efficiently enough, rather than metabolic factors. If a steep gradient is chosen as the constant inclination then a high initial metabolic cost will result, which will limit the test time. Another common method used is to maintain a constant speed while increasing the sine of the angle of inclination. The problem with this method of testing is that if too low a speed is selected then a very steep gradient results before the level of tolerance is reached, and if too high a speed is selected there is a high initial metabolic cost. These problems were addressed in a recent paper by Porszasz et al., 2003 (7). They demonstrated that by increasing walking speed linearly and treadmill gradient curvilinearly, a linear increase in work rate occurs with the subjects fatiguing at a moderate speed. If this protocol could be adapted for use with incomplete SCI patients it would provide an accurate means of testing changes in cardiopulmonary function which may result after treadmill training.
It has recently been recorded that dynamometry (rather than manual muscle scores) should be used to assess changes in voluntary function in incomplete SCI patients (8). Therefore we will employ this approach in this study. Following a spinal injury there is a rapid decline in bone mineral density which increases the risk of fracture following minor trauma. Therefore we will also measure the bone density at the epiphyses and shaft of the tibia and femur to determine if this form of training leads to changes in bone mineral density in this patient population.
By demonstrating that treadmill training can improve the cardiopulmonary fitness of individuals with incomplete SCI, their voluntary strength, and bone mineral density, it will help to provide the evidence that this form of rehabilitation is worthwhile.
By increasing cardiopulmonary fitness it will reduce their risk of developing cardiovascular disease, a major problem in this population due to their sedentary lifestyle. If it can be demonstrated to improve their voluntary function it would suggest that their quality of life and ability to carry out activities of daily living may also improve. Improving their bone density would consequently reduce their risk of fracture. Therefore the results of this study will contribute to the quest of trying to improve the overall health and functional ability of this patient population.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Satisfactory general medical examination
- Incomplete paraplegia or tetraplegia secondary to spinal cord lesion
- Previously discharged from hospital, following primary rehabilitation
- Capable of independent ambulation, with or without orthotic support
Key exclusion criteria (6 listed)
- Female subjects should not be pregnant.
- No significant history of autonomic dysreflexia.
- No history of significant osteoporosis, or associated previous history of spontaneous lower-limb fracture. Bone density will be measured in the epiphyses of the tibia and femur of both legs using peripheral Quantitative Computed Tomography (pQCT).
- No history of coronary heart disease.
- No clinical features of significant cardio-respiratory impairment.
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 |
|---|---|---|
| Treadmill with partial body weight support | Device | – |
| Surface Functional Electrical Stimulation | Device | – |
Primary outcome
peak oxygen uptake
lactate threshold
oxygen uptake kinetics
3 secondary outcomes
torque during maximum voluntary contractions in leg muscles
central activation ratio of leg muscles
bone mineral density in tibia and femur
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
- Background: PubMed 1600188Granat M, Keating JF, Smith AC, Delargy M, Andrews BJ. The use of functional electrical stimulation to assist gait in patients with incomplete spinal cord injury. Disabil Rehabil. 1992 Apr-Jun;14(2):93-7. doi: 10.3109/09638289209167078.
- Background: PubMed 12972882Porszasz J, Casaburi R, Somfay A, Woodhouse LJ, Whipp BJ. A treadmill ramp protocol using simultaneous changes in speed and grade. Med Sci Sports Exerc. 2003 Sep;35(9):1596-603. doi: 10.1249/01.MSS.0000084593.56786.DA.
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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 Treadmill with partial body weight support and 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 4 inclusion and 6 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 11 Sep 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?
peak oxygen uptake. The study lists 3 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 NCT00204126, 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 11 Sep 2006.