Recruiting

Observational Study

Sponsor:

Miami VA Healthcare System

Code:

NCT00909922

Conditions

Lower Limb Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Lower Limb Loss

Study ID

NCT00909922

Start date

Jan, 2006

Status verified date

May, 2009

Completion date

Dec, 2010

Anticipated

Primary completion date

Jun, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Lower Limb Amputees

Unilateral Above knee amputees

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ignacio A Gaunaurd, MSPT

305-575-7000ignacio.gaunaurd@va.gov

Locations

Miami Veterans Affairs Healthcare System

Recruiting

Miami, Florida, United States, 33125

Contacts

Principal Investigator:

Robert S Gailey, PhD,PT

More Information

Sponsor

Miami VA Healthcare System

Last update posted

May 29, 2009

Last verified

May, 2009

Keywords

  • Amputation
  • Amputees
  • Artificial Limbs
  • Leg Length Inequality
  • Lower Extremity
  • Pelvis
  • Posture
  • Prostheses
  • Range of Motion
  • Trunk Muscles

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Miami VA Healthcare System on 2009-05-29.