RECRUITING

Nomad P-KAFO Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05644522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
  3. * Willing to wear and charge an activity monitor for three-months home trials.
  1. * Flexion contracture in the knee and/or hip joint in excess of 15 degrees
  2. * Non-correctable knee varus/valgus in excess of 15 degrees
  3. * Severe spasticity
  4. * Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)

Contacts and Locations

Study Contact

Arun Jayaraman, PhD
CONTACT
312-238-6875
ajayaraman@sralab.org

Study Locations (Sites)

Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

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