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Nomad P-KAFO Study

Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the Nomad powered leg brace in people whose walking is affected by an injury or a condition of the muscles, bones, or nerves. It compares the Nomad with each person's own brace over three months of daily use at home and in the community, looking at movement, balance, falls, and quality of life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Regularly use a leg brace on one or both legs because of a nerve, muscle, or bone condition, or an injury. Eligible braces include KAFOs (knee-ankle-foot braces), SCOs (stance-control braces), or other unpowered KAFOs.
  • Can understand and follow study instructions and are willing to give consent to join.
  • Are willing to wear and charge an activity monitor during the three-month home trial.

Who can't join

  • A hip or knee is stuck in a bent position more than 15 degrees from straight.
  • A knee bends inward or outward more than 15 degrees and cannot be corrected.
  • Have severe spasticity, meaning muscles tighten without your control.
  • Cannot keep your upper body steady, even with aids such as crutches or canes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IL