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Nomad P-KAFO Study

Primary Purpose

Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Group A receives the intervention Nomad KAFO first; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.

Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.

Outcomes

Primary Outcome Measures

Change in 10 Meter Walk Test speed
A test to measure the change of speed of both self selected and fastest walking speeds

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2022
Last Updated
August 4, 2023
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT05644522
Brief Title
Nomad P-KAFO Study
Official Title
Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophy, Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A receives the intervention Nomad KAFO first; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.
Intervention Type
Device
Intervention Name(s)
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
Intervention Description
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 Measure Information:
Title
Change in 10 Meter Walk Test speed
Description
A test to measure the change of speed of both self selected and fastest walking speeds
Time Frame
Baseline, Post 3-month home trials with each device
Secondary Outcome Measure Information:
Title
Six Minute Walk Test
Description
A test to measure how much distance is traveled over the course of 6 minutes.
Time Frame
Baseline, Post 3-month home trials with each device
Title
Berg Balance Test
Description
A test of standing balance
Time Frame
Baseline, Post 3-month home trials with each device
Title
Functional Gait Assessment
Description
A test of postural stability during walking tasks
Time Frame
Baseline, Post 3-month home trials with each device
Title
Hill Assessment Index
Description
Used to assess different gait patterns during ascent or descent of slopes
Time Frame
Baseline, Post 3-month home trials with each device
Title
Stair Assessment Index
Description
Used to assess functional abilities during ascent and descent of stairs
Time Frame
Baseline, Post 3-month home trials with each device
Title
Timed Up and Go
Description
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.
Time Frame
Baseline, Post 3-month home trials with each device
Title
Activities Specific Balance Confidence Scale
Description
A self-report questionnaire designed to measure fear of falling across 16 items.
Time Frame
Baseline, Post 3-month home trials with each device
Title
Modified Falls Efficacy Scale
Description
A self-report questionnaire designed to measure fear of falling across 14 items.
Time Frame
Baseline, Post 3-month home trials with each device
Title
Orthotics and Prosthetics User Survey
Description
A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.
Time Frame
Baseline, Post 3-month home trials with each device
Title
World Health Organization Quality of Life
Description
A self-report questionnaire that measures an individual's perceived quality of life.
Time Frame
Baseline, Post 3-month home trials with each device
Title
EQ5D-5L
Description
A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Baseline, Post 3-month home trials with each device
Title
Numeric Pain Rating Scale
Description
A measure of perceived pain intensity
Time Frame
Baseline, Post 3-month home trials with each device, and as needed throughout course of study.
Title
Borg Rate of Perceived Exertion
Description
A measure of perceived exertion during an activity
Time Frame
Baseline, Post 3-month home trials with each device, and as needed throughout course of study
Title
Manual Muscle Test
Description
A rating of overall gross muscle strength
Time Frame
Screening, Baseline, Post 3-month home trials with each device
Title
Range of Motion (both passive and active)
Description
A measurement of overall joint mobility of both lower extremities
Time Frame
Screening, Baseline, Post 3-month home trials with each device
Title
Six Minute Push Test
Description
A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.
Time Frame
Baseline, Post 3-month home trials with each device
Other Pre-specified Outcome Measures:
Title
Cross Walk Blinking Signal Test
Description
Measuring the time needed to cross a designated street
Time Frame
Baseline, Post 3-month home trials with each device
Title
Community Mobility
Description
Measured by wearing an activity monitor to capture motion / step counts
Time Frame
During each 3 month home trial with each device.
Title
Self Reported Goals
Description
Subjects will be interviewed to understand their self-reported functional goals.
Time Frame
Baseline, Post 3-month home trials with each device

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arun Jayaraman, PhD
Phone
312-238-6875
Email
ajayaraman@sralab.org
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, PhD
Email
ajayaraman@sralab.org

12. IPD Sharing Statement

Learn more about this trial

Nomad P-KAFO Study

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