Musculoskeletal Measurements in Transfemoral Amputees

May 28, 2009 updated by: Miami VA Healthcare System
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Miami, Florida, United States, 33125
        • Recruiting
        • Miami Veterans Affairs Healthcare System
        • Contact:
        • Principal Investigator:
          • Robert S Gailey, PhD,PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Unilateral Transfemoral and Knee Disarticulation Amputees

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Lower Limb Amputees
Unilateral Above knee amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Limb Length Discrepancy
Time Frame: Time of Observation
Time of Observation
Standing Pelvic Tilt
Time Frame: Time of Observation
Time of Observation
Lateral Trunk Flexion
Time Frame: Time of Observation
Time of Observation
Hip Extension Range of Motion
Time Frame: Time of observation
Time of observation

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual Limb Length
Time Frame: Time of Observation
Time of Observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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