Clinical trial NCT00909922: Musculoskeletal Measurements in Transfemoral Amputees
Official title: Musculoskeletal Measurements in Transfemoral Amputees
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Limb Loss
Keywords: Amputation
Amputees
Artificial Limbs
Leg Length Inequality
Lower Extremity
Pelvis
Posture
Prostheses
Range of Motion
Trunk Muscles
Lead sponsor: Miami VA Healthcare System
Sponsor class: FED
First posted: 2009-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unilateral Transfemoral and Knee Disarticulation Amputees

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.


Eligibility 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.

Primary outcomes:
measure: Limb Length Discrepancy
timeFrame: Time of Observation
measure: Standing Pelvic Tilt
timeFrame: Time of Observation
measure: Lateral Trunk Flexion
timeFrame: Time of Observation
measure: Hip Extension Range of Motion
timeFrame: Time of observation
Secondary outcomes:
measure: Residual Limb Length
timeFrame: Time of Observation
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Affairs Healthcare System
state: Florida
Study officials:
References: