C-brace and Stance Control Orthosis for Mobility Impairment

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.

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 data supports the effectiveness of the treatment C-brace and Stance Control Orthosis for Mobility Impairment?

Research shows that users of stance control orthoses, like the C-Brace, experience improvements in walking speed, stride length, and balance, which can enhance mobility and quality of life for individuals with lower limb impairments. ^{1 2 3 4 5}

Is the C-Brace and Stance Control Orthosis safe for humans?

Research indicates that the C-Brace, a type of stance control orthosis, is generally safe for humans and offers benefits over traditional orthoses, although it may not fully replicate the function of a healthy leg. ^{1 3 4 6 7}

How does the C-brace and Stance Control Orthosis treatment differ from other treatments for mobility impairment?

The C-brace and Stance Control Orthosis treatment is unique because it uses a microprocessor to control both the stance and swing phases of walking, allowing for dampened knee flexion and speed-adapted movement. This technology provides more natural and adaptive movement compared to traditional knee-ankle-foot orthoses, which often have safety and functional limitations. ^{1 2 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

A microprocessor stance and swing control orthosis improves balance, risk of falling, mobility, function, and quality of life of individuals dependent on a knee-ankle-foot orthosis for ambulation. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Gait changes over time in stance control orthosis users. [2008]

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

Safety and walking ability of KAFO users with the C-Brace® Orthotronic Mobility System, a new microprocessor stance and swing control orthosis. [2018]

4. France pubmed.ncbi.nlm.nih.gov

Consumer opinions of a stance control knee orthosis. [2019]

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

Microprocessor Controlled Knee Ankle Foot Orthosis (KAFO) vs Stance Control vs Locked KAFO: A Randomized Controlled Trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Treatment of bracing for adolescent idiopathic scoliosis patients: a meta-analysis. [2020]

7. France pubmed.ncbi.nlm.nih.gov

A functional comparison of conventional knee-ankle-foot orthoses and a microprocessor-controlled leg orthosis system based on biomechanical parameters. [2016]

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

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO. [2023]

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

Preliminary kinematic evaluation of a new stance-control knee-ankle-foot orthosis. [2013]