Spinal Cord InjuryPhase 2NCT00013338
Supported Treadmill Ambulation Training After Spinal Cord Injury
A Phase 2 study testing Ambulation Training in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. 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?
- Ambulation Training
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Dec 2002
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Spinal cord injury
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.
- Conditions
- Spinal Cord Injury
- Being tested
- Ambulation Training
- Keywords
- Spinal cord injury, ambulation, treadmill
- 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.
Ambulation TrainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startJan 2000
- Study completionDec 2002
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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph.D. Asst. Director, Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development ServiceNancy Rocheleau, Program Analyst, Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013338
- Sponsor's protocol ID
- B2142R
- Status last verified
- Jan 2001
- First submitted
- 14 Mar 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Treadmill Ambulation Training After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00013338
- Acronym / sponsor ID
- B2142R
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, ambulation, treadmill
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2000
- Study completion
- Dec 2002 (actual)
- First posted
- 16 Mar 2001 (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.
This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Ambulation Training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2009.
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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.
John Fryer, Ph.D. Asst. Director
Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development Service
Nancy Rocheleau, Program Analyst
Program Analysis and Review Section (PARS), Department of Veterans Affairs, Rehabilitation Research and Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambulation Training in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 2009. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 21 Jan 2009.