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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United Kingdom

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.

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.

  1. peak oxygen uptake

  2. lactate threshold

  3. oxygen uptake kinetics

Secondary outcomes (3)
  1. torque during maximum voluntary contractions in leg muscles

  2. central activation ratio of leg muscles

  3. 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.

  1. First posted20 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Study completionFeb 2005

Resources

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
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 1600188
  • Porszasz 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

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.

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