Traumatic Amputation of Lower ExtremityPhase 1NCT01419288
Treadmill Training With Lower Extremity Amputees
A Phase 1 study testing Treadmill Training in people with Traumatic Amputation of Lower Extremity, run by Stony Brook University at 1 site in United States.
Trial summary
Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Traumatic Amputation of Lower Extremity
- What is being tested?
- Treadmill Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2012
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Leg amputation that is either below the knee, through the knee, or above the knee
- Ability to walk with prosthetic
- Comfortably fitted with a prosthesis for at least 6 months
- Not currently receiving physical therapy for gait training
- Able to tolerate a moderate intensity exercise program
Who cannot join
- People with severe cardiac or pulmonary disease that limits ability to exercise.
- People with too much discomfort and/or pain that restricts their ability to walk.
- People with active wounds on their residual limb or contralateral foot.
- People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.
- Conditions
- Traumatic Amputation of Lower Extremity
- Being tested
- Treadmill Training
- Keywords
- Amputees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill TrainingOther
The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.
| Study group | Role | What they receive |
|---|---|---|
| No Body weight support | Active comparator | Not described Receives: Other: Treadmill Training |
| Body weight support | Experimental | Not described Receives: Other: Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 6-minute walk test
Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol
Measured: Baseline, after training, 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Amputation of Lower ExtremityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Lamberg, Stony Brook University
- Investigators
- Eric Lamberg, EdD, PT, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419288
- Sponsor's protocol ID
- 2009-0573-1
- Status last verified
- Jan 2013
- First submitted
- 11 Aug 2011
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Training With Lower Extremity Amputees
- ClinicalTrials.gov ID
- NCT01419288
- Acronym / sponsor ID
- 2009-0573-1
- Conditions
- Traumatic Amputation of Lower Extremity
- Keywords
- Amputees
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Aug 2011 (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.
Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Body weight support | Active comparator | Other: Treadmill Training |
| Body weight support | Experimental | Other: Treadmill Training |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Leg amputation that is either below the knee, through the knee, or above the knee
- Ability to walk with prosthetic
- Comfortably fitted with a prosthesis for at least 6 months
- Not currently receiving physical therapy for gait training
- Able to tolerate a moderate intensity exercise program
Key exclusion criteria (4 listed)
- People with severe cardiac or pulmonary disease that limits ability to exercise.
- People with too much discomfort and/or pain that restricts their ability to walk.
- People with active wounds on their residual limb or contralateral foot.
- People who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.
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 TrainingThe program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training. | Other | Body weight support, No Body weight support |
Primary outcome
Change from Baseline in 6-minute walk test
Time frame: Baseline, after training, 1 month follow-up
Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol
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 10 Jan 2013.
Related trials for Traumatic Amputation of Lower Extremity
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Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
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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.
Eric Lamberg, EdD, PT principal investigator
Stony Brook University
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 Treadmill Training in people with Traumatic Amputation of Lower Extremity, run by Stony Brook University 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?
The sponsor lists 5 inclusion and 4 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 10 Jan 2013. 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 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 from Baseline in 6-minute walk test (time frame: Baseline, after training, 1 month follow-up). 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 10 Jan 2013.