C-brace and Stance Control Orthosis for Mobility Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Unstable neurological, cardiovascular, cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of leg braces, the C-Brace and the stance control orthosis, can assist those with walking difficulties due to nerve or muscle problems, bone issues, or injuries. The researchers aim to determine which brace better enhances movement and overall quality of life. Participants will use both braces to compare their effects. This trial suits individuals who already use a leg brace on one side and have conditions like nerve or muscle disease, orthopedic issues, or trauma affecting walking. As an unphased trial, it allows participants to directly compare innovative brace technologies and potentially improve 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.

What prior data suggests that these devices are safe for improving mobility in individuals with lower extremity impairments?

Research has shown that the C-Brace is generally easy to use and well-received. It aids individuals with walking difficulties by enhancing safety, mobility, and quality of life. The C-Brace supports those with partial paralysis, easing walking by reducing strain.

Studies confirm that the stance control orthosis is safe and effective. It stabilizes the knee by locking it when standing and allows it to bend while walking. Users report improved walking ability and satisfaction with this device.

Both devices have demonstrated safety and effectiveness in improving mobility and quality of life without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer advanced mobility solutions for people with mobility impairments. The C-brace is unique because it uses microprocessor technology to adapt in real-time to the user's movements, providing personalized support and stability. The Stance Control Orthosis, on the other hand, allows for a more natural gait by locking and unlocking the knee joint during walking, something traditional braces don't typically offer. These innovations could significantly enhance the quality of life for individuals with mobility challenges compared to standard rigid braces.

What evidence suggests that this trial's treatments could be effective for mobility impairment?

This trial will compare the effectiveness of the C-Brace and the stance control orthosis for mobility impairment. Research has shown that the C-Brace, which participants in this trial may receive, significantly enhances mobility and daily living for individuals with lower leg issues. Studies indicate that the C-Brace can reduce falls by 80% and improve balance and walking speed, making everyday movements safer and easier.

In contrast, the stance control orthosis, another treatment option in this trial, helps individuals walk faster and take longer steps, promoting a more balanced and natural gait. However, users of this device have reported more frequent falls.

Overall, both devices aim to improve movement, but the C-Brace has stronger evidence for reducing fall risks and enhancing quality of life. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with lower limb impairments due to neurological, neuromuscular, orthopedic diseases or trauma. Participants must have used a knee-ankle-foot orthosis (KAFO) or stance control orthosis (SCO), be able to operate GPS and Actigraph units, and walk reciprocally using SCO and C-Brace tools. Exclusions include severe ankle motion limitations, weight over 275 pounds, unstable health conditions, inability to use the braces effectively, or recent physical therapy specific to gait training.

Inclusion Criteria

Cognitive ability to understand and the willingness to sign a written informed consent

Ability to turn the global positioning sensor (GPS) and Actigraph units on and off and wear the devices each day during use of the orthoses

You have trouble using or moving your legs because of a nerve or muscle condition, bone or joint issues, or a previous injury.

Exclusion Criteria

You can move your ankle less than 2 degrees without using a special brace.

You weigh more than 275 pounds.

You have unstable neurological, heart, lung, or cancer-related health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Training and Treatment

Participants receive training and use the first orthosis device for functional mobility improvement

8 weeks

Regular visits for assessment and training

Crossover and Second Device Training

Participants switch to the second orthosis device and continue training and assessment

8 weeks

Regular visits for assessment and training

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• C-brace
• Stance control orthosis

Trial Overview The study compares two leg braces: the C-Brace which is microprocessor-controlled and the traditional Stance Control Orthosis (SCO). It aims to see if the C-Brace can better improve mobility and quality of life for those with lower extremity disabilities from various causes compared to SCO.

How Is the Trial Designed?

Group I: Stance control orthosis then C-brace Experimental Treatment 2 Interventions

Group II: C-brace then stance control orthosis Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Otto Bock Healthcare Products GmbH

Industry Sponsor

Trials

16

Recruited

880+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316271/

The C-Brace® microprocessor controlled stance and swing ... The C-Brace microprocessor-controlled stance and swing control orthosis has been shown to improve function, mobility, and quality of life.

2. corporate.ottobock.com corporate.ottobock.com/en/media/newsroom/Study-confirms-80-percent-fewer-falls-with-the-C-Brace

Study confirms: 80 per cent fewer falls with the C-Brace The C-Brace reduces falls by 80%, improves balance, mobility, and quality of life, and facilitates everyday movements compared to conventional ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03906656

Clinical Trial Comparing C-Brace to Knee Ankle Foot ... This trial compares the C-Brace to KAFO/SCO for lower limb impairment, using a randomized, controlled, cross-over design, with a 3-month home use period.

4. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2023.2258342

A microprocessor stance and swing control orthosis ... Outcomes for function, mobility, and quality of life showed significant improvements with the C-Brace. Discussion. The improvements in fall risk and mobility ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20556683241269539

The C-Brace® microprocessor controlled stance and swing ... The C-Brace improves safety, mobility, and quality of life, with increased walking speed, reduced falls, and improved balance.

6. ottobock.com ottobock.com/en-us/c-brace

C-Brace is changing lives one step at a time. The C-Brace offers a mobility solution for incomplete paraplegia & poliomyelitis. This leg brace reduces tension and makes it easier to walk.

7. anthem.com anthem.com/medpolicies/abc/active/gl_pw_e002530.html

CG-OR-PR-09 Microprocessor Controlled Knee-Ankle-Foot ... The C-Brace® microprocessor controlled stance and swing orthosis improves safety, mobility, and quality of life at one year: interim results ...