Clinical trial NCT03906656: Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pareses, Lower Extremity
Lead sponsor: Otto Bock Healthcare Products GmbH
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective international multi-center, open-labeled randomized, controlled cross-over trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

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

Primary outcomes:
measure: Primary Efficacy: Berg Balance Scale (BBS)
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Secondary outcomes:
measure: Activity-specific Balance Confidence (ABC) Scale
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Dynamic Gait Index (DGI)
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: 6-minute Walk Test
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Stair Assessment Index (SAI) - Down
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Frequency of Falling
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Fear of Falling
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO
timeFrame: 3 months after initial home use period, and 3 months after cross-over home use period
measure: Reintegration to Normal Living (RNL) Index Questionnaire
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: EQ-5D-5L
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Work Limitations Questionnaires WLQ-25
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Orthotics & Prosthetics User Survey (OPUS)
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Medical Outcomes Study Short Form (SF-36)
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)
timeFrame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
measure: Patient-Related Outcome Questions
timeFrame: 3 months after cross-over home use period
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Hanger Clinic
state: Florida
city: Chicago
country: United States
facility: Scheck & Siress
state: Illinois
city: Houston
country: United States
facility: Hanger Clinic
state: Texas
city: Seattle
country: United States
facility: Hanger Clinic
state: Washington
city: Wien
country: Austria
facility: Orthopädisches Spital Speising Speisingerstraße 109
city: Berlin
country: Germany
facility: BeMoveD - Berlin Movement Diagnostics
state: Deutschland
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz-Montabaur
state: Rhineland-Palatinate
city: Altenberg
country: Germany
facility: Johannesbad Raupennest GmbH & Co. KG
city: Göttingen
country: Germany
facility: Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
city: Hamburg
country: Germany
facility: BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
city: Traunstein
country: Germany
facility: Pohlig GmbH
city: Hoensbroek
country: Netherlands
facility: Adelante Kenniscentrum
state: Limburg
Study officials:
affiliation: Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
name: Frank Braatz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: