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Nomad P-KAFO Study

Nomad P-KAFO Study

Recruiting
18-89 years
All
Phase N/A

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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

Eligibility

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.)

Study details
    Cerebrovascular Accident
    Post-polio Syndrome
    Spinal Cord Injuries
    Multiple Sclerosis
    Muscular Dystrophy
    Paralysis

NCT05644522

Shirley Ryan AbilityLab

17 April 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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