N/A N=11 Randomized Single-blind Treatment

Prosthetic Components and Stability in Amputee Gait

Diabetes Mellitus · Leg Injuries · Traumatic Amputation

Bottom Line

View on ClinicalTrials.gov: NCT00167778 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Local Dynamic Stability (Hip During Straight Walking) — .74; .74 dimensionless — p=>0.99

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transverse plane rotation adaptor pylon (Device); Rigid pylon (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Local Dynamic Stability (Hip During Straight Walking)	.74; .74	>0.99
PRIMARY Local Dynamic Stability (Knee During Straight Walking)	1.00; 1.16	=0.09
PRIMARY Local Dynamic Stability (Ankle During Straight Walking)	.81; .96	=0.09
PRIMARY Local Dynamic Stability (Hip During Turning With the Prosthesis on the Inside of the Turn)	.85; .83	=0.7
PRIMARY Local Dynamic Stability (Knee During Turning With the Prosthesis on the Inside of the Turn)	1.20; 1.20	>0.99
PRIMARY Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Inside of the Turn)	.96; .87	—
PRIMARY Local Dynamic Stability (Hip During Turning With the Prosthesis on the Outside of the Turn)	.75; .74	=0.8
PRIMARY Local Dynamic Stability (Knee During Turning With the Prosthesis on the Outside of the Turn)	1.16; 1.12	=0.7
PRIMARY Local Dynamic Stability (Ankle During Turning With the Prosthesis on the Outside of the Turn)	.84; .96	=.4
SECONDARY Peak External Rotation Moment of the Outside Hip While Turning	-70; -88	>0.15
SECONDARY Peak External Rotation Moment of the Outside Knee While Turning	-7; -15	>0.15
SECONDARY Peak External Rotation Moment of the Outside Ankle While Turning	-28; -42	>0.15
SECONDARY Peak External Rotation Moment of the Inside Hip While Turning	-54; -57	>0.15
SECONDARY Peak External Rotation Moment of the Inside Knee While Turning	-26; -24	>0.15
SECONDARY Peak External Rotation Moment of the Inside Ankle While Turning	-36; -25	>0.15
SECONDARY Activity Level	6269; 6728	=0.13
SECONDARY Six-minute Walk Distance	463; 464	=0.92
SECONDARY Residual Limb Pain at Present?	2.0; 1.6	=0.37
SECONDARY Average Residual Limb Pain?	2.9; 2.3	=0.27
SECONDARY Worst Residual Limb Pain?	4.7; 3.6	=0.20
SECONDARY Least Residual Limb Pain?	1.9; 1.6	=0.59
SECONDARY Pain Interference With Activities?	3.4; 1.6	=0.057
SECONDARY How Bothersome Was Your Pain?	3.1; 2.9	=0.78

Summary

The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability. The objective of this study is to understand the biomechanics of turning gait in sample populations of intact and trans-tibial amputees and the capacity of prosthetic components to facilitate transverse plane movement. The clinical impact of this investigation is the development of interventions that increase functional mobility, stability and safety while turning. The researchers propose to investigate three sets of hypotheses. The first set addresses the fundamental biomechanical mechanisms associated with walking along a circular trajectory, how intact subjects differ from amputees, and the effect of a rotation adaptor pylon. The second set of hypotheses addresses dynamic stability and the potential influence of prosthetic interventions. The third set of hypotheses addresses how the rotational properties of the prosthetic pylon can influence comfort and mobility during daily activities.

Eligibility Criteria

Inclusion Criteria

Amputee Subjects:
be a unilateral trans-tibial amputee between the ages of 18 and 70,
weigh 220 pounds or less,
have been fit with a prosthesis and using a prosthesis for at least two years,
wear the prosthesis for at least 8 hours per day,
walk without crutches or a walker,
able to walk outside the home and in the community,
have not fallin within the last six months,
Non-amputee subjects participating in this investigation will meet similar inclusion criteria except for those related to prosthesis use.

Exclusion Criteria

Amputee Subjects:
amputation due to tumor, have an active tumor, or are undergoing treatment of a tumor,
have pain in legs or any condition that interferes with walking.
Non-amputee subjects participating in this investigation will meet similar exclusion criteria except for those related to cause of amputation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00167778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.