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

Primary Purpose

Pareses, Lower Extremity

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

C-Brace

KAFO/SCO

About this trial

This is an interventional treatment trial for Pareses, Lower Extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hanger Clinic
Scheck & Siress
Hanger Clinic
Hanger Clinic
Orthopädisches Spital Speising Speisingerstraße 109
BeMoveD - Berlin Movement Diagnostics
Katholisches Klinikum Koblenz-Montabaur
Johannesbad Raupennest GmbH & Co. KG
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin
Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
Pohlig GmbH
Adelante Kenniscentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

KAFO/SCO

C-Brace

Arm Description

Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)

Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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.

6-minute walk test

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

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.

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.

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.

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).

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).

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.

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.

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.

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.

Full Information

NCT ID

NCT03906656

First Posted

April 5, 2019

Last Updated

September 6, 2022

Sponsor

Otto Bock Healthcare Products GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03906656

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 11, 2019 (Actual)

Primary Completion Date

August 23, 2022 (Actual)

Study Completion Date

August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otto Bock Healthcare Products GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pareses, Lower Extremity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Prospective international multi-center, open-labeled randomized, controlled cross-over trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KAFO/SCO

Arm Type

Active Comparator

Arm Description

Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)

Arm Title

C-Brace

Arm Type

Experimental

Arm Description

Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.

Intervention Type

Device

Intervention Name(s)

C-Brace

Other Intervention Name(s)

Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

KAFO/SCO

Other Intervention Name(s)

Locked KAFO, Posterior offset KAFO, Stance Control Orthosis

Intervention Description

Current knee ankle foot orthosis that the subject was wearing at baseline

Primary Outcome Measure Information:

Title

Primary Efficacy: Berg Balance Scale (BBS)

Description

Time Frame