Nomad P-KAFO Study

Not Applicable

Recruiting

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

• Registration Number: NCT05644522
• Lead Sponsor: Shirley Ryan AbilityLab

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-09
• Study Start: 2024-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in 10 Meter Walk Test speed	Baseline, Post 3-month home trials with each device	A test to measure the change of speed of both self selected and fastest walking speeds

Secondary Outcome Measures

Name	Time	Method
Functional Gait Assessment	Baseline, Post 3-month home trials with each device	A test of postural stability during walking tasks
Hill Assessment Index	Baseline, Post 3-month home trials with each device	Used to assess different gait patterns during ascent or descent of slopes
World Health Organization Quality of Life	Baseline, Post 3-month home trials with each device	A self-report questionnaire that measures an individual's perceived quality of life.
Borg Rate of Perceived Exertion	Baseline, Post 3-month home trials with each device, and as needed throughout course of study	A measure of perceived exertion during an activity
Berg Balance Test	Baseline, Post 3-month home trials with each device	A test of standing balance
Modified Falls Efficacy Scale	Baseline, Post 3-month home trials with each device	A self-report questionnaire designed to measure fear of falling across 14 items.
Range of Motion (both passive and active)	Screening, Baseline, Post 3-month home trials with each device	A measurement of overall joint mobility of both lower extremities
Stair Assessment Index	Baseline, Post 3-month home trials with each device	Used to assess functional abilities during ascent and descent of stairs
Timed Up and Go	Baseline, Post 3-month home trials with each device	A functional mobility test to measure how long it takes to rise from a chair, walk 3 meters, turn around, and return back to a sitting position in the chair.
Activities Specific Balance Confidence Scale	Baseline, Post 3-month home trials with each device	A self-report questionnaire designed to measure fear of falling across 16 items.
EQ5D-5L	Baseline, Post 3-month home trials with each device	A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Numeric Pain Rating Scale	Baseline, Post 3-month home trials with each device, and as needed throughout course of study.	A measure of perceived pain intensity
Manual Muscle Test	Screening, Baseline, Post 3-month home trials with each device	A rating of overall gross muscle strength
Six Minute Push Test	Baseline, Post 3-month home trials with each device	A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.
Six Minute Walk Test	Baseline, Post 3-month home trials with each device	A test to measure how much distance is traveled over the course of 6 minutes.
Orthotics and Prosthetics User Survey	Baseline, Post 3-month home trials with each device	A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States