Transfemoral Amputation, Transtibial Amputation
Conditions
Keywords
Biomechanics, Kinematics, Walking, Prostheses
Brief summary
The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.
Detailed description
The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.
Interventions
DEVICEConventional prosthetic socket
Participants will use their own conventional rigid socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for \~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
DEVICEAdjustable Quatro socket
Participants will use an adjustable Quatro socket and will be asked to walk on a force-measuring treadmill on level ground at 0.75, 1.0, 1.25, and 1.5 m/s for \~60 sec per speed. They will also be asked to evaluate this socket using a questionnaire.
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* The investigators will enroll up to 40 Veterans * 20 with unilateral transtibial amputation * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old * All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation * Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator
Exclusion criteria
* Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanical Asymmetry | through study completion, an average of 4 years | The assessments of ground reaction forces, and joint motion, torque, power, and work will be aggregated into a measure of asymmetry that compares the percentage difference between the affected and unaffected legs of each participant. The investigators will compare asymmetry between groups and sockets. |
| Prosthetic Evaluation Questionnaire | through study completion, an average of 4 years | The prosthetic evaluation questionnaire assesses comfort and satisfaction. This questionnaire asks participants to rate their comfort and satisfaction based on a 10-point scale and contains 54 questions organized into 9 domain scales, where each scale can be used to independently measure a domain. The investigators will compare overall and domain-specific scores between groups and sockets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socket pistoning | through study completion, an average of 4 years | Movement of the residual limb within the socket. The investigators will compared socket pistoning between groups and sockets. |
Countries
United States
Contacts
CONTACTAlena Grabowski, PhD BA
PRINCIPAL_INVESTIGATORAlena Grabowski, PhD BA
Rocky Mountain Regional VA Medical Center, Aurora, CO
Outcome results
None listed