Nomad P-KAFO Study

Shirley Ryan AbilityLab36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cerebrovascular Accident Post-polio Syndrome Spinal Cord Injuries Multiple Sclerosis

Interventions

Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

Change in 10 Meter Walk Test speed

A test to measure the change of speed of both self selected and fastest walking speeds

Time frame: Baseline, Post 3-month home trials with each device

Secondary Outcomes

Six Minute Walk Test

A test to measure how much distance is traveled over the course of 6 minutes.

Time frame: Baseline, Post 3-month home trials with each device

Berg Balance Test

A test of standing balance

Time frame: Baseline, Post 3-month home trials with each device

Functional Gait Assessment

A test of postural stability during walking tasks

Time frame: Baseline, Post 3-month home trials with each device

Hill Assessment Index

Used to assess different gait patterns during ascent or descent of slopes

Time frame: Baseline, Post 3-month home trials with each device

Stair Assessment Index

Used to assess functional abilities during ascent and descent of stairs

Time frame: Baseline, Post 3-month home trials with each device

Timed Up and Go

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.

Time frame: Baseline, Post 3-month home trials with each device

Activities Specific Balance Confidence Scale

A self-report questionnaire designed to measure fear of falling across 16 items.

Time frame: Baseline, Post 3-month home trials with each device

Modified Falls Efficacy Scale

A self-report questionnaire designed to measure fear of falling across 14 items.

Time frame: Baseline, Post 3-month home trials with each device

Orthotics and Prosthetics User Survey

A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.

Time frame: Baseline, Post 3-month home trials with each device

World Health Organization Quality of Life

A self-report questionnaire that measures an individual's perceived quality of life.

Time frame: Baseline, Post 3-month home trials with each device

EQ5D-5L

A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Time frame: Baseline, Post 3-month home trials with each device

Numeric Pain Rating Scale

A measure of perceived pain intensity

Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.

Borg Rate of Perceived Exertion

A measure of perceived exertion during an activity

Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study

Manual Muscle Test

A rating of overall gross muscle strength

Time frame: Screening, Baseline, Post 3-month home trials with each device

Range of Motion (both passive and active)

A measurement of overall joint mobility of both lower extremities

Time frame: Screening, Baseline, Post 3-month home trials with each device

Six Minute Push Test

A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.

Time frame: Baseline, Post 3-month home trials with each device

Nomad P-KAFO Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts