Nomad P-KAFO Study

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644522
• Other study ID #: STU00217395
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Shirley Ryan AbilityLab
• Contact: Arun Jayaraman, PhD
• Phone: 312-238-6875
• Email: ajayaraman[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

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.)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cross Walk Blinking Signal Test	Measuring the time needed to cross a designated street	Baseline, Post 3-month home trials with each device
Other	Community Mobility	Measured by wearing an activity monitor to capture motion / step counts	During each 3 month home trial with each device.
Other	Self Reported Goals	Subjects will be interviewed to understand their self-reported functional goals.	Baseline, Post 3-month home trials with each device
Primary	Change in 10 Meter Walk Test speed	A test to measure the change of speed of both self selected and fastest walking speeds	Baseline, Post 3-month home trials with each device
Secondary	Six Minute Walk Test	A test to measure how much distance is traveled over the course of 6 minutes.	Baseline, Post 3-month home trials with each device
Secondary	Berg Balance Test	A test of standing balance	Baseline, Post 3-month home trials with each device
Secondary	Functional Gait Assessment	A test of postural stability during walking tasks	Baseline, Post 3-month home trials with each device
Secondary	Hill Assessment Index	Used to assess different gait patterns during ascent or descent of slopes	Baseline, Post 3-month home trials with each device
Secondary	Stair Assessment Index	Used to assess functional abilities during ascent and descent of stairs	Baseline, Post 3-month home trials with each device
Secondary	Timed Up and Go	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.	Baseline, Post 3-month home trials with each device
Secondary	Activities Specific Balance Confidence Scale	A self-report questionnaire designed to measure fear of falling across 16 items.	Baseline, Post 3-month home trials with each device
Secondary	Modified Falls Efficacy Scale	A self-report questionnaire designed to measure fear of falling across 14 items.	Baseline, Post 3-month home trials with each device
Secondary	Orthotics and Prosthetics User Survey	A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.	Baseline, Post 3-month home trials with each device
Secondary	World Health Organization Quality of Life	A self-report questionnaire that measures an individual's perceived quality of life.	Baseline, Post 3-month home trials with each device
Secondary	EQ5D-5L	A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Baseline, Post 3-month home trials with each device
Secondary	Numeric Pain Rating Scale	A measure of perceived pain intensity	Baseline, Post 3-month home trials with each device, and as needed throughout course of study.
Secondary	Borg Rate of Perceived Exertion	A measure of perceived exertion during an activity	Baseline, Post 3-month home trials with each device, and as needed throughout course of study
Secondary	Manual Muscle Test	A rating of overall gross muscle strength	Screening, Baseline, Post 3-month home trials with each device
Secondary	Range of Motion (both passive and active)	A measurement of overall joint mobility of both lower extremities	Screening, Baseline, Post 3-month home trials with each device
Secondary	Six Minute Push Test	A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.	Baseline, Post 3-month home trials with each device