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

Trial Summary

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 data supports the effectiveness of the treatment Indego Nomad® Powered Knee-Ankle-Foot Orthosis for mobility impairments?

Research shows that knee-ankle-foot orthoses (KAFOs) can improve walking speed and step length in people with conditions like stroke and poliomyelitis. New designs, such as those with stance control, help users walk more naturally by allowing the knee to move during walking, which may suggest potential benefits for the Indego Nomad® Powered KAFO. ^{1 2 3 4 5}

Is the Powered KAFO generally safe for human use?

There is no specific safety data available for the Powered KAFO, but long-term use of similar devices like the locked knee ankle foot orthosis (L-KAFO) has been associated with risks such as low back pain, osteoarthritis, skin issues, and increased energy use, which can affect quality of life. ^{1 2 3 6 7}

How does the Indego Nomad® Powered KAFO treatment differ from other treatments for mobility impairments?

The Indego Nomad® Powered KAFO is unique because it is a powered orthosis that assists with both knee and ankle movement, potentially offering more dynamic support compared to traditional KAFOs, which often have locked joints and can lead to increased energy expenditure and other complications over time. ^{2 3 6 8 9}

What is the purpose of this trial?

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. The brace provides extra support and power to make walking easier and safer.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Sweden 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. [2022]

2. England 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. [2018]

3. France pubmed.ncbi.nlm.nih.gov

Gait of stance control orthosis users: the dynamic knee brace system. [2017]

4. Japan 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. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Therapeutic Experience on Stance Control Knee-Ankle-Foot Orthosis With Electromagnetically Controlled Knee Joint System in Poliomyelitis. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

State of the art review of knee-ankle-foot orthoses. [2015]

8. France pubmed.ncbi.nlm.nih.gov

Biomechanical study of a knee-ankle-foot-orthosis for hemiplegic patients. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Knee-ankle-foot orthosis in children with duchenne muscular dystrophy: user views and adjustment. [2015]