Powered KAFO for Mobility Impairments

Overseen By Arun Jayaraman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Severe spasticity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the Nomad powered KAFO (a type of brace) assists individuals with walking difficulties due to past injuries. It will compare the Nomad's effects on mobility, balance, and quality of life against participants' current braces over a three-month period. Participants will use both their own brace and the Nomad to determine which works better for them. The trial suits those who regularly use a brace, can follow instructions, and are comfortable wearing an activity monitor at home. As an unphased trial, it offers participants the chance to directly compare a new brace with their current one, potentially enhancing their mobility and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mobility aids rather than medication use.

What prior data suggests that the Nomad powered KAFO is safe for individuals with mobility impairments?

Research has shown that specific safety information for the Nomad powered KAFO (knee-ankle-foot brace) is not yet available. However, similar devices, such as the locked knee-ankle-foot brace, have been used for a long time without major safety issues. These types of braces are generally well-tolerated, meaning most people do not experience serious problems when using them. Although the Nomad is a newer device, its design resembles those that have been safely used before. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Indego Nomad® Powered Knee-Ankle-Foot Orthosis (KAFO) because it offers a new way to assist people with mobility impairments. Unlike traditional assistive devices, which often require manual effort and provide limited support, the Nomad KAFO is a powered device that uses advanced technology to help users walk more naturally and with less strain. This innovative approach allows for dynamic, personalized adjustments to movement, potentially improving user comfort and independence. By offering enhanced mobility support through a powered mechanism, the Nomad KAFO could significantly enhance quality of life for individuals with mobility challenges.

What evidence suggests that the Nomad powered KAFO is effective for improving mobility in individuals with lower-extremity impairments?

Research has shown that the Indego Nomad powered KAFO (Knee-Ankle-Foot Orthosis), which participants in this trial may receive, can improve mobility for those with walking difficulties due to muscle or nerve injuries. Early studies suggest that powered KAFOs like the Nomad may enhance balance, reduce fall risk, and improve overall quality of life. While researchers continue to gather specific data on the Nomad, it provides powered support to the legs, helping users walk more steadily and confidently. Designed for daily use, these devices can lead to noticeable improvements over time. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like paralysis, muscular dystrophy, or spinal cord injury that affect walking. Participants must regularly use a leg brace due to their condition, be able to follow the study's instructions, and consent to wearing an activity monitor for three months.

Inclusion Criteria

I understand the study details and agree to participate.

I regularly use a leg brace due to a neurological, muscle, or bone condition.

I am willing to wear and charge an activity monitor for three months.

Exclusion Criteria

I cannot keep my body stable, even with support like crutches.

My knee or hip cannot fully straighten, bending more than 15 degrees.

My knee is bent inward/outward more than 15 degrees and can't be fixed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Training and Fitting

Participants receive training and fitting for the Nomad powered KAFO or their own Traditional Assistive Device

1-2 weeks

2 visits (in-person)

Home Trial with Device

Participants use the assigned device (Nomad KAFO or Traditional Assistive Device) for a 3-month home trial, followed by outcomes testing

12 weeks

Ongoing monitoring with activity sensor

Crossover and Second Home Trial

Participants switch devices and undergo a second 3-month home trial with outcomes testing

12 weeks

Ongoing monitoring with activity sensor

Follow-up

Participants are monitored for safety and effectiveness after the completion of both home trials

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Indego Nomad® Powered Knee-Ankle-Foot Orthosis

Trial Overview The Nomad P-KAFO is being tested for its effectiveness in improving mobility and quality of life over three months compared to participants' usual braces. It involves recording daily activities with a sensor and assessing mobility using both the participant's own brace and the Nomad P-KAFO.

How Is the Trial Designed?

Group I: Group A Experimental Treatment 1 Intervention

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 II: Group B Active Control 1 Intervention

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.

Indego Nomad® Powered Knee-Ankle-Foot Orthosis is already approved in United States, European Union for the following indications:

Approved in United States as Indego Nomad Powered KAFO for:

• Musculoskeletal injuries affecting lower extremities
• Neurological injuries affecting lower extremities

Approved in European Union as Nomad P-KAFO for:

• Lower-extremity impairments due to neurological or neuromuscular diseases
• Lower-extremity impairments due to orthopedic diseases or trauma

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Knee-ankle-foot orthoses (KAFOs) are categorized into three types: passive, stance control (SC), and dynamic, each with different mechanisms for assisting ambulation, with dynamic KAFOs being the most advanced in controlling knee motion during walking.

Dynamic KAFOs using linear springs and torsional rods can mimic the natural stiffness of the knee during walking, showing promise for better functional outcomes, but further research is needed to improve designs that replicate normal knee function throughout the entire gait cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the art review of knee-ankle-foot orthoses. Tian, F., Hefzy, MS., Elahinia, M.[2015]

In a review of 14 articles involving 15 cases, knee-ankle-foot orthosis (KAFO) showed clinically meaningful improvements in functional mobility for 10 out of 15 stroke patients, as measured by various mobility scales.

The review also indicated improvements in activities of daily living (ADL) for 9 out of 15 cases, but the overall methodological quality of the studies was low, highlighting the need for better reporting on limitations and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Knee-Ankle-Foot Orthosis on Functional Mobility and Activities of Daily Living in Patients with Stroke: A Systematic Review of Case Reports. Kobayashi, E., Hiratsuka, K., Haruna, H., et al.[2022]

Long-term use of locked knee ankle foot orthoses (L-KAFO) can lead to various negative health effects, including musculoskeletal changes, gait asymmetry, and increased energy expenditure, which may result in low back pain and osteoarthritis.

The article suggests that recent advancements in rehabilitation engineering could provide better alternatives to improve daily activities and independence for individuals who require lower limb support, reducing the risks associated with L-KAFO use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term locked knee ankle foot orthosis use: A perspective overview of iatrogenic biomechanical and physiological perils. Ghoseiri, K., Zucker-Levin, A.[2023]

Novice users of the Dynamic Knee Brace System (DKBS) showed significant improvements in walking speed and cadence compared to traditional locked knee-ankle-foot orthoses (KAFOs), indicating enhanced mobility with the new stance control design.

Experienced KAFO users did not experience the same benefits and showed reduced walking speed and cadence, suggesting that their established gait patterns may hinder their ability to adapt to the new orthosis effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait of stance control orthosis users: the dynamic knee brace system. Irby, SE., Bernhardt, KA., Kaufman, KR.[2017]

Families of children with Duchenne muscular dystrophy (DMD) generally had a positive attitude towards the use of knee ankle foot orthoses (KAFOs), with over two-thirds expressing satisfaction, despite initial feelings of illness deterioration upon their introduction.

Mental distress was notably high among primary caregivers, with 41% showing high psychiatric risk, highlighting the need for comprehensive support and preparation for families using KAFOs in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knee-ankle-foot orthosis in children with duchenne muscular dystrophy: user views and adjustment. Garralda, ME., Muntoni, F., Cunniff, A., et al.[2015]

In a study of 381 hospitalized patients with subacute stroke, those using ankle-foot orthoses (AFOs) showed significantly greater improvements in mobility compared to those using knee-ankle-foot orthoses (KAFOs) from admission to discharge.

Factors such as age, the Brunnstrom stage of the paretic limb, and initial functional independence scores were found to significantly influence mobility gains, highlighting the need for tailored interventions based on individual characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difference in independent mobility improvement from admission to discharge between subacute stroke patients using knee-ankle-foot and those using ankle-foot orthoses. Ota, T., Hashidate, H., Shimizu, N., et al.[2020]

The study involving nine adults with poliomyelitis showed that using heel-to-toe rocker-soled footwear with knee-ankle-foot orthoses (KAFOs) significantly increased maximum hip joint extension and stride length, suggesting improved gait mechanics.

While the rocker sole adaptation did not significantly increase walking speed or cadence, it reduced hip abduction and adduction, indicating potential benefits for ambulation in patients using KAFOs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of footwear adapted with a multi-curved rocker sole in conjunction with knee-ankle-foot orthoses on walking in poliomyelitis subjects: a pilot study. Mojaver, A., Arazpour, M., Aminian, G., et al.[2018]

The use of a stance control KAFO (SCKAFO) with an electromagnetically controlled knee joint significantly improved gait parameters such as velocity, step length, and stride length in a 54-year-old man with poliomyelitis after rehabilitation.

Rehabilitation therapy, including muscle re-education and balance training over 4 months, was essential in conjunction with the SCKAFO to achieve a more normal gait pattern, highlighting the importance of combined interventions for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Experience on Stance Control Knee-Ankle-Foot Orthosis With Electromagnetically Controlled Knee Joint System in Poliomyelitis. Kim, JH., Ji, SG., Jung, KJ., et al.[2020]

The clinical evaluation of a new knee-ankle-foot-orthosis (KAFO) was conducted on 120 hemiplegic patients over a six-year period, demonstrating its practical application in improving mobility.

The KAFO features a genucentric knee joint and a specially designed ankle joint, which may enhance the functional outcomes for patients with hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical study of a knee-ankle-foot-orthosis for hemiplegic patients. Morinaka, Y., Matsuo, Y., Nojima, M., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05644522

Study Details | NCT05644522 | Nomad P-KAFO Study 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 ...

2. withpower.com withpower.com/trial/phase-cerebrovascular-accident-2023-a3127

Powered KAFO for Mobility Impairments This trial is testing a special powered leg brace called the Nomad powered KAFO. It aims to help people who have trouble walking due to injuries.

3. ctv.veeva.com ctv.veeva.com/study/nomad-p-kafo-study

Nomad P-KAFO Study - ClinicalTrials.Veeva The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and ...

4. sralab.org sralab.org/clinical-trials/power-forward-study-cross-sector-multisite-clinical-trial-powered-knee-ankle-foot-orthosis

A Cross-Sector, Multisite Clinical Trial of a Powered Knee ... 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9285852/

EFFICACY OF KNEE–ANKLE–FOOT ORTHOSIS ON ... This systematic review of case reports found a low level of evidence of the efficacy of KAFO in terms of improvement in functional mobility and ADL.