Clinical trial NCT05644522: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Accident
Post-polio Syndrome
Spinal Cord Injuries
Multiple Sclerosis
Muscular Dystrophy
Paralysis
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.)

Primary outcomes:
measure: Change in 10 Meter Walk Test speed
timeFrame: Baseline, Post 3-month home trials with each device
Secondary outcomes:
measure: Six Minute Walk Test
timeFrame: Baseline, Post 3-month home trials with each device
measure: Berg Balance Test
timeFrame: Baseline, Post 3-month home trials with each device
measure: Functional Gait Assessment
timeFrame: Baseline, Post 3-month home trials with each device
measure: Hill Assessment Index
timeFrame: Baseline, Post 3-month home trials with each device
measure: Stair Assessment Index
timeFrame: Baseline, Post 3-month home trials with each device
measure: Timed Up and Go
timeFrame: Baseline, Post 3-month home trials with each device
measure: Activities Specific Balance Confidence Scale
timeFrame: Baseline, Post 3-month home trials with each device
measure: Modified Falls Efficacy Scale
timeFrame: Baseline, Post 3-month home trials with each device
measure: Orthotics and Prosthetics User Survey
timeFrame: Baseline, Post 3-month home trials with each device
measure: World Health Organization Quality of Life
timeFrame: Baseline, Post 3-month home trials with each device
measure: EQ5D-5L
timeFrame: Baseline, Post 3-month home trials with each device
measure: Numeric Pain Rating Scale
timeFrame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.
measure: Borg Rate of Perceived Exertion
timeFrame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study
measure: Manual Muscle Test
timeFrame: Screening, Baseline, Post 3-month home trials with each device
measure: Range of Motion (both passive and active)
timeFrame: Screening, Baseline, Post 3-month home trials with each device
measure: Six Minute Push Test
timeFrame: Baseline, Post 3-month home trials with each device
Other outcomes:
measure: Cross Walk Blinking Signal Test
timeFrame: Baseline, Post 3-month home trials with each device
measure: Community Mobility
timeFrame: During each 3 month home trial with each device.
measure: Self Reported Goals
timeFrame: Baseline, Post 3-month home trials with each device
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: