36 Participants Needed

Powered KAFO for Mobility Impairments

AJ
Overseen ByArun Jayaraman, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Shirley Ryan AbilityLab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12367

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.23689

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.
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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
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 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 BActive Control1 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

Find a Clinic Near You

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

References

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]
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]
Gait of stance control orthosis users: the dynamic knee brace system. [2017]
Difference in independent mobility improvement from admission to discharge between subacute stroke patients using knee-ankle-foot and those using ankle-foot orthoses. [2020]
Therapeutic Experience on Stance Control Knee-Ankle-Foot Orthosis With Electromagnetically Controlled Knee Joint System in Poliomyelitis. [2020]
Long-term locked knee ankle foot orthosis use: A perspective overview of iatrogenic biomechanical and physiological perils. [2023]
State of the art review of knee-ankle-foot orthoses. [2015]
Biomechanical study of a knee-ankle-foot-orthosis for hemiplegic patients. [2017]
Knee-ankle-foot orthosis in children with duchenne muscular dystrophy: user views and adjustment. [2015]
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