Clinical trial NCT02828982: Determining the Potential Benefit of Powered Prostheses
Official title: Determining the Potential Benefit of Powered Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Traumatic Amputation
Amputation, Traumatic
Keywords: powered ankle prosthesis
activity monitoring
muscle fatigue
below knee amputation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.

Detailed description: Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.

Eligibility criteria: Inclusion Criteria:

* Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes

Exclusion Criteria:

* History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time

Primary outcomes:
measure: Metabolic Cost of Walking
timeFrame: Testing took place after wearing the prostheses for two weeks
measure: Total Steps Outside the Home Over a Two Week Period
timeFrame: 2 weeks
measure: Quality of Life (QoL) on a Short-Form 36
timeFrame: Questionnaire completed 2 weeks after wearing each prosthesis
Secondary outcomes:
measure: Prosthetic Evaluation Questionnaire (PEQ)
timeFrame: Questionnaire completed 2 weeks after wearing each prosthesis
measure: Muscle Activity in the Lower Limb
timeFrame: Testing took place after the participant wore the prosthesis for 2 weeks
measure: Time to Fatigue
timeFrame: Testing took place after wearing the prostheses for two weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Deanna H Gates, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2.