Microprocessor Knees in Early Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?

Conditions
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Amputation

Intervention / Treatment
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* Device: Ottobock Kenevo/C-Leg
* Device: Ottobock 3R60/3R62


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microprocessor Knee<br>Ottobock Kenevo/Ottobock C-Leg | Device: Ottobock Kenevo/C-Leg<br>* Microprocessor-controlled prosthetic knee<br>|
| Active Comparator: Nonmicroprocessor knee<br>Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants. | Device: Ottobock 3R60/3R62<br>* Nonmicroprocessor-controlled knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Limb Users Survey of Mobility | Self-reported prosthetic mobility | Monthly for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall frequency | Number of falls while using the prosthesis | Monthly for 3 months | 
| Daily step count | Walking activity measured with StepWatch Monitor | Average daily step count by month for 3 months | 
| Timed up and go | Timed performance test that measures rising from a chair, walking 3m, and returning to a seated position. | Monthly for 3 months | 
| Amputee Mobility Predictor (AMPPro) Assessment Tool | 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. | Monthly for 3 months | 
| Six-minute walk test | Evaluates distance walked over 6 minute time frame with rest as needed | Monthly for 3 months | 
| Gait quality | GaitRite System, pressure sensitive instrumented walkway will collect average walking speed, step width, step time asymmetry during 6 minute walk test | Monthly for 3 months | 
| Activities-Specific Balance Confidence Scale (ABC) | 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). | Baseline and monthly for 3 months | 
| Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0 | Self-reported measure of Physical Function, satisfaction with social roles, fatigue, sleep disturbance, pain intensity, pain interference, anxiety and depression | Baseline and monthly for 3 months | 
| Reintegration to Normal Living Index (RNLI) | 11 item questionnaire to assess self-reported physical, social and psychologic performance following injury | Baseline and monthly for 3 months |