Musculoskeletal Measurements in Transfemoral Amputees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909922
Recruitment Status : Unknown
Verified May 2009 by Miami VA Healthcare System.
Recruitment status was:  Recruiting
First Posted : May 29, 2009
Last Update Posted : May 29, 2009
Information provided by:
Miami VA Healthcare System

Brief 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. 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.

Condition or disease
Lower Limb Loss

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Musculoskeletal Measurements in Transfemoral Amputees
Study Start Date : January 2006
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Lower Limb Amputees
Unilateral Above knee amputees

Primary Outcome Measures :
  1. Limb Length Discrepancy [ Time Frame: Time of Observation ]
  2. Standing Pelvic Tilt [ Time Frame: Time of Observation ]
  3. Lateral Trunk Flexion [ Time Frame: Time of Observation ]
  4. Hip Extension Range of Motion [ Time Frame: Time of observation ]

Secondary Outcome Measures :
  1. Residual Limb Length [ Time Frame: Time of Observation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Unilateral Transfemoral and Knee Disarticulation Amputees

Inclusion Criteria:

Healthy Individuals with:

  1. Unilateral transfemoral or knee disarticulation amputations between the ages 18 to 80.
  2. History of at least one episode of low back pain in the past.
  3. Ambulate independently of an assisted device or those who require the use of a cane or crutches for walking on level grounds.
  4. Comfortably fitted with prosthesis for a period of at least 6 months.
  5. More than 12 months post-amputation.

Exclusion Criteria:

Individuals with:

  1. Amputation on the contralateral limb.
  2. Open wound on non-amputated side.
  3. Neurological disorders such as Parkinson's disease or stroke that affect their ability to ambulate.
  4. Who require a walker or wheelchair for locomotion on level ground.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909922

Contact: Ignacio A Gaunaurd, MSPT 305-575-7000 ext 4477

United States, Florida
Miami Veterans Affairs Healthcare System Recruiting
Miami, Florida, United States, 33125
Contact: Mitscher Gajardo, BS    305-575-7000 ext 4465   
Principal Investigator: Robert S Gailey, PhD,PT         
Sponsors and Collaborators
Miami VA Healthcare System

Responsible Party: Robert S. Gailey, PhD, PT, Miami VA Healtcare System Identifier: NCT00909922     History of Changes
Other Study ID Numbers: 3019.02
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Miami VA Healthcare System:
Artificial Limbs
Leg Length Inequality
Lower Extremity
Range of Motion
Trunk Muscles