Elevated Metabolic CostVRVO2NCT01225432
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
A study testing Gait Training in people with Elevated Metabolic Cost, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Metabolic Cost
- What is being tested?
- Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2011
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unilateral traumatic trans-tibial or transfemoral amputation
- Independent ambulation without an assistive device for a minimum of three months
- Ability to ambulate continuously for a minimum of 15 minutes
- Trans-femoral participants must use an ischial containment socket
- VAS Pain scores on the involved side of less than 4/10
- Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.
Who cannot join
- Blindness
- TBI-Glascow Coma Scale score of 12 or lower at the time of injury
- Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Intrepid
Fort Sam Houston, Texas, 78234
About this study
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.
- Conditions
- Elevated Metabolic Cost
- Being tested
- Gait Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrainingOther
12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.
| Study group | Role | What they receive |
|---|---|---|
| Gait Training | Experimental | Not described Receives: Other: Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Oxygen Consumption
Measured: 3 weeks
Gait Oxygen Consumption
Measured: Immediately prior to start of 3 week training.
Gait Oxygen Consumption
Measured: Immediately post training
Gait Oxygen Consumption
Measured: 3 weeks later from first post training testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startAug 2007
- Primary completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Metabolic CostStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, Director, Military Performance Lab-Center for the Intrepid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225432
- Sponsor's protocol ID
- C.2008.050dt
- Acronym
- VRVO2
- Status last verified
- Oct 2010
- First submitted
- 19 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT01225432
- Acronym / sponsor ID
- VRVO2 / C.2008.050dt
- Conditions
- Elevated Metabolic Cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Aug 2007
- Primary completion
- Sep 2011 (estimated)
- First posted
- 21 Oct 2010 (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.
To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait Training | Experimental | Other: Gait Training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Unilateral traumatic trans-tibial or transfemoral amputation
- Independent ambulation without an assistive device for a minimum of three months
- Ability to ambulate continuously for a minimum of 15 minutes
- Trans-femoral participants must use an ischial containment socket
- VAS Pain scores on the involved side of less than 4/10
Key exclusion criteria (3 listed)
- Blindness
- TBI-Glascow Coma Scale score of 12 or lower at the time of injury
- Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
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 |
|---|---|---|
| Gait Training12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics. | Other | Gait Training |
Primary outcome
Gait Oxygen Consumption
Time frame: 3 weeks
Gait Oxygen Consumption
Time frame: Immediately prior to start of 3 week training.
Gait Oxygen Consumption
Time frame: Immediately post training
Gait Oxygen Consumption
Time frame: 3 weeks later from first post training testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
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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.
Jason M Wilken, PT, PhD principal investigator
Director, Military Performance Lab-Center for the Intrepid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training in people with Elevated Metabolic Cost, run by Brooke Army Medical Center 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 6 inclusion and 3 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 21 Oct 2010. 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.
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?
Gait Oxygen Consumption (time frame: 3 weeks). The study lists 4 primary outcomes in all. 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 21 Oct 2010.