Spinal Cord InjuryPhase 1NCT00108043
Orthostatic Tolerance During FES (Functional Electrical Stimulation)-Walking in Paraplegia
A Phase 1 study testing FES-evoked functional upright gait in people with Spinal Cord Injury, run by University of Sydney at 1 site in Australia.
Trial summary
Objective: The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- FES-evoked functional upright gait
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2004to Dec 2006
- Phase
- Phase 1
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- A spinal cord lesion, of traumatic etiology, between the 6th and 11th thoracic spinal segments
- Sensory and motor complete lesion (ASIA [American Spinal Injury Association]-A)
- At least 2 years post injury
- Between 18-55 years of age
- Responsive to electrical stimulation
Who cannot join
- Severe osteoporosis, fractures, dislocations (as determined by X-ray and DEXA)
- Upper limb or shoulder pathologies
- Severe spasticity (≥4 on Ashworth scale)
- Contractures
- Currently undertaking FES or gait training
Trial locations and contacts
1 site in 1 country.
Australia1 site
Rehabilitation Research Centre, University of Sydney
Sydney, New South Wales, 2141
About this study
Official title: Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study
Objective:
The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors governing orthostatic tolerance during skin-surface FES stepping will be investigated, since this functional task forms the basis of upright mobility and engenders strong physiological challenges upon key regulatory processes in the SCI (spinal cord injury) patient.
Read more
Specific Hypotheses:
- Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
Read the detailed description
Aims:
The primary aim of the safety and viability study is to assess changes in blood pressure during up to 60-min of FES-evoked stepping versus up to 60-min of stepping.
A secondary aim is to investigate changes in blood pressure during FES-assisted stepping with and without a voluntary upper-limb component of gait.
Specific Hypotheses:
- Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
Primary Outcome: The primary outcome measure for this study is the change of systolic blood pressure during three FES-evoked stepping conditions, as described below. Each condition is defined as up to 60-min of continuous gait.
Secondary Outcomes: Secondary outcomes include a change of diastolic blood pressure and the duration of orthostatic tolerance. Orthostatic tolerance will be assessed as the time that the subject can perform stepping before the onset of orthostatic hypotension. The duration of orthostatic tolerance will be determined by the time at which one of the following occur: (i) 60 continuous minutes of stepping; or (ii) orthostatic hypotension, defined as a reduction in systolic blood pressure of > 20 mmHg or diastolic blood pressure of >10 mmHg; or (iii) signs and symptoms of pre-syncope; or (iii) upon subject request. Throughout each trial, heart rate and blood pressure will be monitored continuously. In addition to the primary and secondary outcome variables, several additional measurements that may contribute to orthostatic tolerance, or indeed, intolerance, will be assessed at 10-min intervals during stepping.
- Conditions
- Spinal Cord Injury
- Being tested
- FES-evoked functional upright gait
- Keywords
- Functional Electrical Stimulation, Gait, Blood pressure, Orthostatic Hypotension, Cardiovascular responses, Near-infra red spectroscopy
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-evoked functional upright gaitProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of systolic blood pressure during three FES-evoked stepping conditions
Secondary outcomes (5)
Cardiovascular and Metabolic Responses
Autonomic Responses
Muscle Metabolic Responses
Humoral Responses
Syncope Symptom Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2005 (estimated)
- Study startMar 2004
- Study completionDec 2006
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Investigators
- Glen M Davis, PhD, FACSM, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108043
- Sponsor's protocol ID
- NHMRC 302013
- Status last verified
- Dec 2015
- First submitted
- 12 Apr 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthostatic Tolerance During FES-evoked Stepping in Paraplegia: A Safety and Viability Study
- ClinicalTrials.gov ID
- NCT00108043
- Acronym / sponsor ID
- NHMRC 302013
- Conditions
- Spinal Cord Injury
- Keywords
- Functional Electrical Stimulation, Gait, Blood pressure, Orthostatic Hypotension, Cardiovascular responses, Near-infra red spectroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Apr 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.
Objective:
The objective of this research is to undertake a safety and viability study of FES-evoked stepping in individuals with paraplegia. The rationale for this objective is based upon the need to clarify whether physiological limitations, especially orthostatic intolerance, limit functional mobility outcomes. The cardiovascular, autonomic, and muscle metabolic factors governing orthostatic tolerance during skin-surface FES stepping will be investigated, since this functional task forms the basis of upright mobility and engenders strong physiological challenges upon key regulatory processes in the SCI (spinal cord injury) patient.
Specific Hypotheses:
- Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
Detailed description
Aims:
The primary aim of the safety and viability study is to assess changes in blood pressure during up to 60-min of FES-evoked stepping versus up to 60-min of stepping.
A secondary aim is to investigate changes in blood pressure during FES-assisted stepping with and without a voluntary upper-limb component of gait.
Specific Hypotheses:
- Reduction of blood pressure will be greater during FES-evoked stepping than during passive stepping; ii. Reduction of blood pressure will be greater during FES-evoked stepping with no upper body component versus FES-stepping with an upper body component; iii. Blood pressure will be reduced even further during FES-evoked stepping following a 6-week progressive-intensity gait training intervention.
Primary Outcome: The primary outcome measure for this study is the change of systolic blood pressure during three FES-evoked stepping conditions, as described below. Each condition is defined as up to 60-min of continuous gait.
Secondary Outcomes: Secondary outcomes include a change of diastolic blood pressure and the duration of orthostatic tolerance. Orthostatic tolerance will be assessed as the time that the subject can perform stepping before the onset of orthostatic hypotension. The duration of orthostatic tolerance will be determined by the time at which one of the following occur: (i) 60 continuous minutes of stepping; or (ii) orthostatic hypotension, defined as a reduction in systolic blood pressure of > 20 mmHg or diastolic blood pressure of >10 mmHg; or (iii) signs and symptoms of pre-syncope; or (iii) upon subject request. Throughout each trial, heart rate and blood pressure will be monitored continuously. In addition to the primary and secondary outcome variables, several additional measurements that may contribute to orthostatic tolerance, or indeed, intolerance, will be assessed at 10-min intervals during stepping.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- A spinal cord lesion, of traumatic etiology, between the 6th and 11th thoracic spinal segments
- Sensory and motor complete lesion (ASIA [American Spinal Injury Association]-A)
- At least 2 years post injury
- Between 18-55 years of age
Key exclusion criteria (5 listed)
- Severe osteoporosis, fractures, dislocations (as determined by X-ray and DEXA)
- Upper limb or shoulder pathologies
- Severe spasticity (≥4 on Ashworth scale)
- Contractures
- Currently undertaking FES or gait training
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 |
|---|---|---|
| FES-evoked functional upright gait | Procedure or surgery | – |
Primary outcome
Change of systolic blood pressure during three FES-evoked stepping conditions
5 secondary outcomes
Cardiovascular and Metabolic Responses
Autonomic Responses
Muscle Metabolic Responses
Humoral Responses
Syncope Symptom Score
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 3 Dec 2015.
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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.
Glen M Davis, PhD, FACSM principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FES-evoked functional upright gait in people with Spinal Cord Injury, run by University of Sydney at 1 site in Australia.
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 6 inclusion and 5 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 3 Dec 2015. 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 Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of systolic blood pressure during three FES-evoked stepping conditions. 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 3 Dec 2015.