NCT00909922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

4.4 years

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Keywords

AmputationAmputeesArtificial LimbsLeg Length InequalityLower ExtremityPelvisPostureProsthesesRange of MotionTrunk Muscles

Outcome Measures

Primary Outcomes (4)

  • Limb Length Discrepancy

    Time of Observation

  • Standing Pelvic Tilt

    Time of Observation

  • Lateral Trunk Flexion

    Time of Observation

  • Hip Extension Range of Motion

    Time of observation

Secondary Outcomes (1)

  • Residual Limb Length

    Time of Observation

Study Arms (1)

Lower Limb Amputees

Unilateral Above knee amputees

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unilateral Transfemoral and Knee Disarticulation Amputees

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Veterans Affairs Healthcare System

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Ignacio A Gaunaurd, MSPT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations