Lower Limb LossNCT00909922
Musculoskeletal Measurements in Transfemoral Amputees
An observational study of Lower Limb Loss, run by Miami VA Healthcare System at 1 site in United States.
Trial summary
The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb length indirectly to determine the proportion of participants with LLD and to quantify the mean amount of discrepancy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Loss
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2010
- Phase
- Observational
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unilateral Transfemoral and Knee Disarticulation Amputees
Who may be able to join
- Healthy Individuals with:
- Unilateral transfemoral or knee disarticulation amputations between the ages 18 to 80.
- History of at least one episode of low back pain in the past.
- Ambulate independently of an assisted device or those who require the use of a cane or crutches for walking on level grounds.
- Comfortably fitted with prosthesis for a period of at least 6 months.
- More than 12 months post-amputation.
Who cannot join
- Individuals with:
- Amputation on the contralateral limb.
- Open wound on non-amputated side.
- Neurological disorders such as Parkinson's disease or stroke that affect their ability to ambulate.
- Who require a walker or wheelchair for locomotion on level ground.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miami Veterans Affairs Healthcare System
Miami, Florida, 33125
Mitscher Gajardo, BS, 305-575-7000 ext. 4465, mitscher.gajardo@va.gov
Robert S Gailey, PhD,PT
About this study
The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb length indirectly to determine the proportion of participants with LLD and to quantify the mean amount of discrepancy. The investigators hypothesized that a majority of transfemoral amputees would present with a short prosthetic limb. 2) To measure pelvic tilt to determine if transfemoral amputees undergo musculoskeletal adaptations similar to those reported in the literature. The investigators hypothesized that transfemoral amputees would present with a greater degree of anterior pelvic tilt and pelvic innominate asymmetry than what has been previously reported. 3) To assess restriction in lateral trunk flexion and hip extension to determine if asymmetry was present and if it was related to the increase in anterior pelvic tilt. The investigators hypothesized that restrictions would be found in the lateral trunk flexors and hip flexors on the amputated side contributing to posture asymmetry at the pelvis. 4) To determine if musculoskeletal adaptations at the pelvis were affected by prosthetic limb length, lateral trunk flexion and hip extension restrictions, and residual limb length. The investigators hypothesized that the previously reported posture asymmetries would contribute to musculoskeletal adaptations at the pelvis and trunk. Results of the present study will provide a reference for clinicians when using clinical evaluation measures to determine the presence of posture asymmetries in transfemoral amputees. If posture asymmetries are detected, clinicians need to determine musculoskeletal structures at fault and offer treatment solutions to prevent secondary impairments.
- Conditions
- Lower Limb Loss
- Keywords
- Amputation, Amputees, Artificial Limbs, Leg Length Inequality, Lower Extremity, Pelvis, Posture, Prostheses, Range of Motion, Trunk Muscles
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Amputees | Unilateral Above knee amputees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Length Discrepancy
Measured: Time of Observation
Standing Pelvic Tilt
Measured: Time of Observation
Lateral Trunk Flexion
Measured: Time of Observation
Hip Extension Range of Motion
Measured: Time of observation
Secondary outcomes (1)
Residual Limb Length
Measured: Time of Observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJan 2006
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miami VA Healthcare System
- Sponsor type
- US federal agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909922
- Sponsor's protocol ID
- 3019.02
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Measurements in Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT00909922
- Acronym / sponsor ID
- 3019.02
- Conditions
- Lower Limb Loss
- Keywords
- Amputation, Amputees, Artificial Limbs, Leg Length Inequality, Lower Extremity, Pelvis, Posture, Prostheses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Miami VA Healthcare SystemUS federal agency
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 29 May 2009 (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.
The aim of this study was to identify posture asymmetries in transfemoral amputees utilizing clinical evaluation measures. The purposes of this investigation were: 1) to measure the limb length indirectly to determine the proportion of participants with LLD and to quantify the mean amount of discrepancy. The investigators hypothesized that a majority of transfemoral amputees would present with a short prosthetic limb. 2) To measure pelvic tilt to determine if transfemoral amputees undergo musculoskeletal adaptations similar to those reported in the literature. The investigators hypothesized that transfemoral amputees would present with a greater degree of anterior pelvic tilt and pelvic innominate asymmetry than what has been previously reported. 3) To assess restriction in lateral trunk flexion and hip extension to determine if asymmetry was present and if it was related to the increase in anterior pelvic tilt. The investigators hypothesized that restrictions would be found in the lateral trunk flexors and hip flexors on the amputated side contributing to posture asymmetry at the pelvis. 4) To determine if musculoskeletal adaptations at the pelvis were affected by prosthetic limb length, lateral trunk flexion and hip extension restrictions, and residual limb length. The investigators hypothesized that the previously reported posture asymmetries would contribute to musculoskeletal adaptations at the pelvis and trunk. Results of the present study will provide a reference for clinicians when using clinical evaluation measures to determine the presence of posture asymmetries in transfemoral amputees. If posture asymmetries are detected, clinicians need to determine musculoskeletal structures at fault and offer treatment solutions to prevent secondary impairments.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Amputees | – | –Unilateral Above knee amputees |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unilateral Transfemoral and Knee Disarticulation Amputees
Key inclusion criteria (6 listed)
- Unilateral transfemoral or knee disarticulation amputations between the ages 18 to 80.
- History of at least one episode of low back pain in the past.
- Ambulate independently of an assisted device or those who require the use of a cane or crutches for walking on level grounds.
- Comfortably fitted with prosthesis for a period of at least 6 months.
- More than 12 months post-amputation.
Key exclusion criteria (5 listed)
- Amputation on the contralateral limb.
- Open wound on non-amputated side.
- Neurological disorders such as Parkinson's disease or stroke that affect their ability to ambulate.
- Who require a walker or wheelchair for locomotion on level ground.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Limb Length Discrepancy
Time frame: Time of Observation
Standing Pelvic Tilt
Time frame: Time of Observation
Lateral Trunk Flexion
Time frame: Time of Observation
Hip Extension Range of Motion
Time frame: Time of observation
1 secondary outcome
Residual Limb Length
Time frame: Time of Observation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Loss, run by Miami VA Healthcare System 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 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: status not confirmed, as of the sponsor's last update on 29 May 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.
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?
Contact Ignacio A Gaunaurd, MSPT (305-575-7000 ext. 4477, ignacio.gaunaurd@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Length Discrepancy (time frame: Time of Observation). 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 29 May 2009.