Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)

Study Overview
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Brief Summary
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Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses

Detailed Description
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After obtaining informed consent, patients will be screened. For subjects fulfilling inclusion/exclusion criteria, a first baseline assessment will be conducted. Within one to two days, a second set of baseline data will be collected for performance measures. Subjects will then be randomly assigned to be fitted with C-Brace or to continue wearing the current KAFO/SCO. After fitting, an accommodation period follows that will last up to 14 days prior to the initial home use. The first follow-up data collection will occur after three months of the initial home use period. Afterwards, the patients will cross over to KAFO/SCO or C-Brace, respectively. The participants who were fitted with C-Brace will cross over to KAFO/SCO and vice versa. Another accommodation phase will be offered for both C-Brace and KAFO/SCO wearers to ensure that subjects can properly use both devices before the cross-over home use period. The second follow-up data collection will occur after 3-months of the cross-over home use period. At the end of the study, the patients can choose to keep the C-Brace for up to 24 months until reimbursement or to return to their original KAFO/SCO.

Official Title
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Multinational Randomized Controlled Cross-over Trial Comparing C -Brace to Conventional Knee Ankle Foot Orthoses With Respect to Balance, Fall Risk and Activities of Daily Living

Conditions
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Pareses, Lower Extremity

Intervention / Treatment
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* Device: C-Brace
* Device: KAFO/SCO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully Patient has a BBS score < 45 Lower limb functional impairment according to CE label wording Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study Patient meets minimum physical requirements to be fitted with a C-Brace, such as muscle status, joint mobility, leg axis and proper control of the orthosis must be guaranteed. The User must fulfill the physical and mental requirements for perceiving optical/acoustic signals and/or mechanical vibrations The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the limb (compensation using the hip is possible). Patient´s commitment to use C-Brace 2 at least 1-2 hours per day 5 days per week- Patient is ≥ 18 years old Patient is willing and able to independently provide informed consent. Person is willing to comply with study procedures Exclusion Criteria: Patient who is not able to follow the entire study visits or is unwilling/unable to follow the instructions Patient was not able to use DTO Patient who is not using an orthosis at least 1 to 2 hours/ day for 5 days per week Patient with body weight > 125 kg (includes body weight and heaviest object (weight) carried) Patient with Orthoprosthesis Patient with flexion contracture in the knee and/or hip joint in excess of 10° Patient with uncontrolled moderate to severe spasticity (relative contraindication moderate spasticity) Leg length discrepancy in excess of 15 cm Patient with unstable neurological or cardiovascular/pulmonary disease, cancer Pregnancy Patient using a C-Brace Patient with known vertigo or with history of falls unrelated to orthosis use or unrelated to motor disability Patient who has never been fitted an orthosis before Patient is not able to answer the self-administered questionnaires independently; for patients with upper extremity impairment is it allowed to verbally answer the questions. Patient participating already in a study during this study´s duration Patient participated in earlier C-Brace studies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective international multi-center, open-labeled randomized, controlled cross-over trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KAFO/SCO<br>Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) | Device: KAFO/SCO<br>* Current knee ankle foot orthosis that the subject was wearing at baseline<br>* Other names: Locked KAFO, Posterior offset KAFO, Stance Control Orthosis;|
| Experimental: C-Brace<br>Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. | Device: C-Brace<br>* The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.<br>* Other names: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy: Berg Balance Scale (BBS) | The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Primary Safety: Frequency of Falling | Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity-specific balance confidence (ABC) Scale | Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Dynamic gait index (DGI) | An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| 6-minute walk test | Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Stair Assessment Index (SAI) | A 14-point ordinal scale (0 - 13) used to assess different gait patterns during both ascent and descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Fear of falling | Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Reintegration to Normal Living (RNL) Index questionnaire | 11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| EQ-5D-5L | Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Work limitations questionnaires WLQ-25 | 25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time). | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Orthotics & Prosthetics User Survey (OPUS) | A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Medical Outcomes Study Short Form (SF-36) | 36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Quebec User Evaluation on Satisfaction with Assistive Technology (QUEST) | 12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction. | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 
| Patient-Related Outcome Questions | Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 0=much worse and 4=much better. | 3 months after cross-over home use period |