Cerebrovascular Accident, Multiple Sclerosis, Muscular Dystrophy, Paralysis, Post-polio Syndrome, Spinal Cord Injuries
Conditions
Brief summary
The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: * Wear a sensor that records everyday activities and mobility. * Perform measures of mobility and different activities of participation using their own brace. * Perform measures of mobility and different activities of participation using the Nomad powered KAFO
Interventions
DEVICEIndego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma * Cognitive ability to understand and follow the study protocol; willingness to provide informed consent * Willing to wear and charge an activity monitor for three-months home trials.
Exclusion criteria
* Flexion contracture in the knee and/or hip joint in excess of 15 degrees * Non-correctable knee varus/valgus in excess of 15 degrees * Severe spasticity * Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 10 Meter Walk Test speed | Baseline, Post 3-month home trials with each device | A test to measure the change of speed of both self selected and fastest walking speeds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test | Baseline, Post 3-month home trials with each device | A test to measure how much distance is traveled over the course of 6 minutes. |
| Berg Balance Test | Baseline, Post 3-month home trials with each device | A test of standing balance |
| Functional Gait Assessment | Baseline, Post 3-month home trials with each device | A test of postural stability during walking tasks |
| Hill Assessment Index | Baseline, Post 3-month home trials with each device | Used to assess different gait patterns during ascent or descent of slopes |
| Stair Assessment Index | Baseline, Post 3-month home trials with each device | Used to assess functional abilities during ascent and descent of stairs |
| Timed Up and Go | Baseline, Post 3-month home trials with each device | A functional mobility test to measure how long it takes to rise from a chair, walk 3 meters, turn around, and return back to a sitting position in the chair. |
| Activities Specific Balance Confidence Scale | Baseline, Post 3-month home trials with each device | A self-report questionnaire designed to measure fear of falling across 16 items. |
| Modified Falls Efficacy Scale | Baseline, Post 3-month home trials with each device | A self-report questionnaire designed to measure fear of falling across 14 items. |
| Orthotics and Prosthetics User Survey | Baseline, Post 3-month home trials with each device | A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. |
| World Health Organization Quality of Life | Baseline, Post 3-month home trials with each device | A self-report questionnaire that measures an individual's perceived quality of life. |
| EQ5D-5L | Baseline, Post 3-month home trials with each device | A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Numeric Pain Rating Scale | Baseline, Post 3-month home trials with each device, and as needed throughout course of study. | A measure of perceived pain intensity |
| Borg Rate of Perceived Exertion | Baseline, Post 3-month home trials with each device, and as needed throughout course of study | A measure of perceived exertion during an activity |
| Manual Muscle Test | Screening, Baseline, Post 3-month home trials with each device | A rating of overall gross muscle strength |
| Range of Motion (both passive and active) | Screening, Baseline, Post 3-month home trials with each device | A measurement of overall joint mobility of both lower extremities |
| Six Minute Push Test | Baseline, Post 3-month home trials with each device | A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes. |
Countries
United States
Contacts
CONTACTArun Jayaraman, PhD
Outcome results
None listed