Clinical trial NCT03204513: Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction
Official title: Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transfemoral Amputees
Keywords: Prosthesis
Powered Prosthesis
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Upon screening and enrollment participants return for up to 8 prosthetic fitting sessions and up to 12 physical therapy training sessions using their own microprocessor (MP) knee prosthesis and the powered knee-ankle (PKA) prosthesis. Once training is complete participants will return for up to 6 post-training assessment sessions per device. The device participants begin with will be randomly selected but there will be equal opportunity to train with both devices. In between training, there will be an 8 week "wash out period" to allow normalization to use of the device, reducing carryover effects. After wash-out period protocol will be repeated with second device.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.

Detailed description: The overall goal of this research is to bring powered devices, with suitable advanced control systems, to the clinic and home. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics.

The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using a powered knee-ankle prosthesis, identify task-specific training strategies for every-day device use, and quantify functional performance and quality of life changes at home and in the community. The hypothesis is that the powered knee-ankle prosthesis will demonstrate a significant improvement in function over existing technology. Furthermore, the hypothesis is that incorporating neural control information will provide enhanced, intuitive control of this device. Thus the approach is to directly compare the powered device with current state-of-art passive microprocessor controlled (MP) prostheses using a randomized cross-over study to control for subject-specific variation.

1.1 Aim 1: Perform in-laboratory training and testing to compare gait biomechanics and clinical performance over several ambulation modes using either a passive prosthesis or a powered prosthesis. The expectation is the PKA prosthesis to enable gait kinetics and kinematics that more closely resemble those of individuals with intact limbs, therefore lowering the biomechanical and metabolic effects of ambulation.

1.2 Aim 2: Perform home trials to evaluate community mobility and social interaction when using a powered knee-ankle prosthesis or a passive device. The expectation is that participants will choose to complete more diverse functional, occupational, and recreational activities when using the PKA prosthesis.

1.3 Aim 3: Quantify performance with the PKA device when using a novel intent recognition algorithm that allows for seamless transitioning between activities compared to a standard control method. The expectation is that pattern recognition- based control will further improve mobility and decrease the physiological costs of ambulation compared to using the standard control method.

Eligibility criteria: Inclusion Criteria:

* Unilateral transfemoral level limb loss or limb difference
* K2/K3/K4 level ambulators
* Required to use a microprocessor knee on their prosthesis

Exclusion Criteria:

* Over 250 lbs body weight
* Inactive, physically unfit
* Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments
* Pregnant women
* Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Primary outcomes:
measure: Change between devices of the Modified Graded Treadmill Test
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Change in Biomechanical Assessment [Gait Parameters and Surface Electromyography (EMG) Activation] Between Devices
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
Secondary outcomes:
measure: Change in Manual Muscle Test (MMT)
timeFrame: Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Change in Passive Range of Motion (PROM)
timeFrame: Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Change in Active Range of Motion (AROM)
timeFrame: Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: 6 Minute Walk Test (6MWT) with COSMED K4B2 Metabolic unit
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Hill Assessment Index (HAI)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Stair Assessment Index (SAI)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Cross Walk Blinking Signal Test
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: GAITRite® Data Capture
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: 5 Times Sit to Stand Test (5XSST)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: 4-Square Step Test
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Talks While Walking Test (TWWT- Dual task test)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Outdoor Uneven Surfaces Test
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Amputee Mobility Predictor
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Mini Mental State Exam (MMSE)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
Other outcomes:
measure: Modified Falls Efficacy Scale (mFES)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Prosthesis Evaluation Questionnaire (PEQ)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Orthotics & Prosthetics User Survey (OPUS)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: Week 1 (Pre-Assessment); Week 2 (Training Assessment); Week 3 (Training Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Socket Comfort Scale (SCS)
timeFrame: Week 1 (Pre-Assessment); Week 2 (Training Assessment); Week 3 (Training Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Prosthetic Limb Users Survey of Mobility™ (PLUS-M™)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
timeFrame: Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: QUEBEC Back Pain Disability Scale
timeFrame: Week 1 (Pre-Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
measure: Borg Rate of Perceived Exertion (Borg RPE)
timeFrame: Week 1 (Pre-Assessment); Week 2 (Training Assessment); Week 3 (Training Assessment); Week 6-7 (Post-Training Assessments); Weeks 21-22 (Post-Training Assessment)
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: