Clinical Trial Comparing C-Brace to Knee Ankle Foot Ortho... | NCT03906656

NCT03906656

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KAFO/SCO	Active Comparator	Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)	Device: KAFO/SCO
C-Brace	Experimental	Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.	Device: C-Brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-Brace	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Module

Eligibility Criteria

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

Contacts/Locations Module

Name	Affiliation	Role
Frank Braatz, Dr. med.	Zentrum für Healthcare Technology der Privaten Hochschule Göttingen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hanger Clinic		Sarasota	Florida	34233	United States
Scheck & Siress

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37752724	Derived	Ruetz A, DiBello T, Toelle C, Hemmen B, Wening J, Weber E, Braatz F, Winkler T, Steinfeldt F, Umari M, Rupp R, Kluge S, Krebs A, Wurdeman SR. 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. Disabil Rehabil. 2024 Aug;46(17):4019-4032. doi: 10.1080/09638288.2023.2258342. Epub 2023 Sep 26.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	KAFO/SCO, Then C-Brace	Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 16, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG00052 subjects
FG00150 subjects

Intention to Treat Group

Arm/Group Information

ID	Title	Description
BG000	KAFO/SCO, Then C-Brace	Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.
BG001	C-Brace, Then KAFO/SCO	Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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. Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00033.6± 11.0 OG00137.3± 10.5 OG00242.0± 9.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	H0: the mean difference (C-Brace - KAFO) <= 0.	t-test, 2 sided		0.0002	Adjusted p-values based on Holm-Bonferroni method. P-values < 0.05 used as threshold for statistical significance.	Mean Difference (Final Values)	3.5	Standard Deviation	8.1	2-Sided						Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).		Superiority

Secondary

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.

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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.

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

6-minute Walk Test

Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.

Intention to Treat Group

Posted

Mean

Standard Deviation

meters

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

Stair Assessment Index (SAI) - Down

A 14-point ordinal scale (0 - 13) used to assess different gait patterns during 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.

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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

Intention to Treat Group

Posted

Mean

Standard Deviation

number of falls in a three month period

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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.

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO

Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods

Paired data including subjects with fall history after both KAFO and C-Brace home use periods

Posted

Count of Participants

Participants

3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO).
OG001	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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.

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).

Intention to Treat Group

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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).

Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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.

Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace

Secondary

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.

Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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.

Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 months after initial home use period, and 3 months after cross-over home use period

ID	Title	Description
OG000	Baseline	Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
OG001	KAFO	Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
OG002	C-Brace	Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.

Secondary

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 1=much worse and 5=much better.

Subjects that answered the patient-reported outcome questions after having completed home-use periods with both KAFO/SCO and C-Brace (at Visit 2). 75 subjects provided answers to these questions.

Posted

Median

Inter-Quartile Range

units on a scale

3 months after cross-over home use period

ID	Title	Description
OG000	KAFO/SCO, Then C-Brace	Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.
OG001	C-Brace, Then KAFO/SCO	Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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. Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	KAFO/SCO	Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO). May also include a period of time when the C-Brace was being fabricated prior to the C-Brace home use of 3 months. KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline	0	102	10	102	66	102
EG001	C-Brace	Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. C-Brace: 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.	2	88	6	88	57	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Chest Pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0011 events1 affected88 at risk
Cholecystolithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
COVID-19	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events1 affected102 at risk EG0010 events0 affected88 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Prostate cancer	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected46 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Systemic scleroderma	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Hand operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0011 events1 affected88 at risk
Stroke	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Food poisoning	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Indigestion	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected88 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Increased fall frequency	General disorders	Sponsor	Systematic Assessment	A significant increase in falls when comparing one home use period to another	EG0007 events6 affected102 at risk EG0011 events1 affected88 at risk
Swelling of legs	General disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Cystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected88 at risk
Immunodeficiency syndromes	Immune system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Multiple sclerosis aggravated	Immune system disorders	MedDRA	Systematic Assessment		EG0002 events2 affected102 at risk EG0011 events1 affected88 at risk
Psoriasis	Immune system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
COVID-19	Infections and infestations	MedDRA	Systematic Assessment		EG0002 events2 affected102 at risk EG0015 events4 affected88 at risk
Candida infection	Infections and infestations	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Cold symptoms	Infections and infestations	MedDRA	Systematic Assessment		EG0005 events5 affected102 at risk EG0013 events3 affected88 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Flu	Infections and infestations	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Klebsiella Infection	Infections and infestations	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Stomach Virus	Infections and infestations	MedDRA	Systematic Assessment		EG0003 events3 affected102 at risk EG0011 events1 affected88 at risk
Injurious Fall	Injury, poisoning and procedural complications	Sponsor	Systematic Assessment	A complete fall, all the way to the ground, that resulted in an injury	EG00037 events21 affected102 at risk EG00115 events10 affected88 at risk
Open Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected88 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Ankle sprain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0008 events8 affected102 at risk EG0017 events7 affected88 at risk
Fibula Fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Foot Fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0012 events2 affected88 at risk
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0012 events1 affected88 at risk
Leg Cramps	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected88 at risk
Muscle Pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected88 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Pain in foot	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0003 events3 affected102 at risk EG0017 events6 affected88 at risk
Pain in hip	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0013 events3 affected88 at risk
Pain in leg	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0008 events8 affected102 at risk EG0019 events8 affected88 at risk
Pain in toe	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected88 at risk
Patella Fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Post polio syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Shoulder Pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0012 events2 affected88 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Dysaesthesia	Nervous system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected88 at risk
Lumbar spinal stenosis	Nervous system disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected88 at risk
Neuralgia	Nervous system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Additional strap necessary	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Alignment Issue	Product Issues	Sponsor	Systematic Assessment	A mismatch between the alignment of the orthosis and the subject's physiologic limb	EG0000 events0 affected102 at risk EG0012 events2 affected88 at risk
Battery holder defect	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected2 at risk EG0010 events0 affected0 at risk
Beeping	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected2 at risk EG0013 events3 affected88 at risk
Bluetooth Malfunction	Product Issues	Sponsor	Systematic Assessment	Connectivity issues to the orthosis via the phone app	EG0000 events0 affected2 at risk EG0013 events3 affected88 at risk
Broken Spring	Product Issues	Sponsor	Systematic Assessment		EG0004 events4 affected102 at risk EG0010 events0 affected88 at risk
Broken Strap	Product Issues	Sponsor	Systematic Assessment		EG0003 events3 affected102 at risk EG0014 events3 affected88 at risk
Broken foot stirrup	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Charging Malfunction	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected2 at risk EG0014 events4 affected88 at risk
Clicking/cracking noises	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected88 at risk
Delamination	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Foot plate fracture	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected102 at risk EG0012 events2 affected88 at risk
Insufficient Padding	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Joint Malfunction	Product Issues	Sponsor	Systematic Assessment		EG0007 events7 affected102 at risk EG0013 events2 affected88 at risk
Loose Screw	Product Issues	Sponsor	Systematic Assessment		EG0005 events4 affected102 at risk EG0011 events1 affected88 at risk
Loss of oil	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected2 at risk EG0011 events1 affected88 at risk
Modified foot plate	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Poor Fit	Product Issues	Sponsor	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Service Light	Product Issues	Sponsor	Systematic Assessment		EG0000 events0 affected2 at risk EG0013 events3 affected88 at risk
Unexpected mode switch	Product Issues	MedDRA	Systematic Assessment	Either switching to a freeze/safety mode, or free swing unexpectedly	EG0001 events1 affected7 at risk EG0014 events4 affected88 at risk
Vaginal bleeding	Reproductive system and breast disorders	MedDRA	Systematic Assessment		EG0001 events1 affected45 at risk EG0010 events0 affected42 at risk
Sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0016 events5 affected88 at risk
Nail bed inflammation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected88 at risk
Skin Abrasion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment		EG0003 events3 affected102 at risk EG0019 events8 affected88 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events1 affected88 at risk
Epistaxis	Vascular disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk
Syncope	Vascular disorders	MedDRA	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected88 at risk

The study was affected by the COVID pandemic. Home-use periods interrupted by the pandemic were restarted, and the study was re-opened for enrollment of another 59 subjects. Neither the subjects nor investigators were blinded for interventions. Only subjects with impaired balance (BBS<45) were included. It is unclear whether the amount of device training was sufficient.

Certain Agreements

ID	Term
D010291	Paresis

Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.

C-Brace: 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.

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms