Nomad P-KAFO Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorShirley Ryan AbilityLab

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Berg Balance Test

A test of standing balance

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

Functional Gait Assessment

A test of postural stability during walking tasks

Time frame
Baseline, Post 3-month home trials with each device
4

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

Other outcomes

1

Cross Walk Blinking Signal Test

Measuring the time needed to cross a designated street

Time frame
Baseline, Post 3-month home trials with each device
2

Community Mobility

Measured by wearing an activity monitor to capture motion / step counts

Time frame
During each 3 month home trial with each device.
3

Self Reported Goals

Subjects will be interviewed to understand their self-reported functional goals.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.