Amputation
Conditions
Brief summary
High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury. The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.
Interventions
DEVICEOttobock Kenevo/C-Leg
Microprocessor-controlled prosthetic knee
DEVICEOttobock 3R60/3R62
Nonmicroprocessor-controlled knee
Sponsors
United States Department of Defense
Otto Bock Healthcare Products GmbH
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators who will conduct performance-based assessments will be blinded to the intervention.
Intervention model description
Pilot randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older, Unilateral transfemoral amputation, Between 4-16 weeks post amputation, Deemed ready for prosthetic fitting by a physician, No current or prior transfemoral prosthetic use, Able to read, write and communicate in English, Weight 125kg (275lbs) or less
Exclusion criteria
* Diagnosis of health condition (i.e. advanced cardiac disease, severe or end-stage pulmonary disease or severe dementia) that prevents safe prosthesis use or community ambulation with prosthesis, Weight greater than 125kg (275lbs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic Limb Users Survey of Mobility | Monthly for 3 months | Self-reported prosthetic mobility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily step count | Average daily step count by month for 3 months | Walking activity measured with StepWatch Monitor |
| Timed up and go | Monthly for 3 months | Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position. |
| Amputee Mobility Predictor (AMPPro) Assessment Tool | Monthly for 3 months | The name of this tool is the Amputee Mobility Predictor (AMPPro) and it was developed by Robert Gailey, PhD, PT (https://www.sralab.org/rehabilitation-measures/amputee-mobility-predictor-0). The AMPPro assesses performance-based mobility for people who use prosthetic limbs. Example items include standing balance, ability to vary cadence, and ability to step over an obstacle. |
| Six-minute walk test | Monthly for 3 months | Evaluates distance walked over 6 minute time frame with rest as needed |
| Fall frequency | Monthly for 3 months | Number of falls while using the prosthesis |
| Activities-Specific Balance Confidence Scale (ABC) | Baseline and monthly for 3 months | The Activities-Specific Balance Confidence Scale (ABC) measures the construct of balance confidence. The 16-item ABC survey asks respondents to rate their confidence in performing a variety of activities without becoming unstable (e.g., walking in the home, walking on a ramp, walking in crowds). Response options range from no confidence to completely confident when performing the activity. The revised scale proposed by Sakakibara (2011) will be used to calculate a total balance confidence score; scores for participants will range from 0 (low balance confidence) to 4 (high balance confidence). |
| Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0 | Baseline and monthly for 3 months | Self-reported measure of Physical Function, satisfaction with social roles, fatigue, sleep disturbance, pain intensity, pain interference, anxiety and depression |
| Reintegration to Normal Living Index (RNLI) | Baseline and monthly for 3 months | 11 item questionnaire to assess self-reported physical, social and psychologic performance following injury |
| Gait quality | Monthly for 3 months | GaitRite System, pressure sensitive instrumented walkway will collect average walking speed, step width, step time asymmetry during 6 minute walk test |
Countries
United States
Outcome results
None listed