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Recruiting NCT05644522

Nomad P-KAFO Study

No phase Interventional Cerebrovascular Accident Post-polio Syndrome Spinal Cord Injuries Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH).
Who it may be relevant to
Registry conditions: Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

  • Device Indego 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.

Primary outcome measures

  • Change in 10 Meter Walk Test speed [Time frame: Baseline, Post 3-month home trials with each device]
Secondary outcome measures (12)
  • Six Minute Walk Test [Time frame: Baseline, Post 3-month home trials with each device]
  • Berg Balance Test [Time frame: Baseline, Post 3-month home trials with each device]
  • Functional Gait Assessment [Time frame: Baseline, Post 3-month home trials with each device]
  • Hill Assessment Index [Time frame: Baseline, Post 3-month home trials with each device]
  • Stair Assessment Index [Time frame: Baseline, Post 3-month home trials with each device]
  • Timed Up and Go [Time frame: Baseline, Post 3-month home trials with each device]
  • Activities Specific Balance Confidence Scale [Time frame: Baseline, Post 3-month home trials with each device]
  • Modified Falls Efficacy Scale [Time frame: Baseline, Post 3-month home trials with each device]
  • Orthotics and Prosthetics User Survey [Time frame: Baseline, Post 3-month home trials with each device]
  • World Health Organization Quality of Life [Time frame: Baseline, Post 3-month home trials with each device]
  • EQ5D-5L [Time frame: Baseline, Post 3-month home trials with each device]
  • Numeric Pain Rating Scale [Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.]

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Shirley Ryan AbilityLab — Chicago

Identifiers

NCT: NCT05644522 · STU00217395

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗