Trial record 2 of 24 for:    prosthetic limbs | Open Studies

Musculoskeletal Measurements in Transfemoral Amputees

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Miami VA Healthcare System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Miami VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00909922
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Lower Limb Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Musculoskeletal Measurements in Transfemoral Amputees

Resource links provided by NLM:


Further study details as provided by Miami VA Healthcare System:

Primary Outcome Measures:
  • Limb Length Discrepancy [ Time Frame: Time of Observation ] [ Designated as safety issue: No ]
  • Standing Pelvic Tilt [ Time Frame: Time of Observation ] [ Designated as safety issue: No ]
  • Lateral Trunk Flexion [ Time Frame: Time of Observation ] [ Designated as safety issue: No ]
  • Hip Extension Range of Motion [ Time Frame: Time of observation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Residual Limb Length [ Time Frame: Time of Observation ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lower Limb Amputees
Unilateral Above knee amputees

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Unilateral Transfemoral and Knee Disarticulation Amputees

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909922

Contacts
Contact: Ignacio A Gaunaurd, MSPT 305-575-7000 ext 4477 ignacio.gaunaurd@va.gov

Locations
United States, Florida
Miami Veterans Affairs Healthcare System Recruiting
Miami, Florida, United States, 33125
Contact: Mitscher Gajardo, BS    305-575-7000 ext 4465    mitscher.gajardo@va.gov   
Principal Investigator: Robert S Gailey, PhD,PT         
Sponsors and Collaborators
Miami VA Healthcare System
  More Information

No publications provided

Responsible Party: Robert S. Gailey, PhD, PT, Miami VA Healtcare System
ClinicalTrials.gov Identifier: NCT00909922     History of Changes
Other Study ID Numbers: 3019.02
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014