Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204126
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-09-12
Brief Title:
Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
Determination of Novel Methods of Exercise Testing During Treadmill Gait in Incomplete Spinal Cord Injury
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 123456 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 persons 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 subjects ability to move their legs quickly andor 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
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 123456 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 persons 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 subjects ability to move their legs quickly andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None