Pareses, Lower ExtremityNCT03906656
Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
A study testing C-Brace and KAFO/SCO in people with Pareses, Lower Extremity, run by Otto Bock Healthcare Products GmbH at 13 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pareses, Lower Extremity
- What is being tested?
- C-Brace and KAFO/SCO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 11 Mar 2019to 23 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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°
Show all 16Show fewer
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
Germany7 sites
Johannesbad Raupennest GmbH & Co. KG
Altenberg, 01773
BeMoveD - Berlin Movement Diagnostics
Berlin, Deutschland, 10117
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
Göttingen, 37073
BG Klinikum Hamburg gGmbH Zentrum für Rehabilitationsmedizin
Hamburg, 21033
Universitätsklinikum Heidelberg, Zentrum für Orthopädie, Unfallchirurgie und Paraplegiologie
Heidelberg, 69118
Katholisches Klinikum Koblenz-Montabaur
Koblenz, Rhineland-Palatinate, 56073
Pohlig GmbH
Traunstein, 83278
United States4 sites
Scheck & Siress
Chicago, Illinois, 60657
Hanger Clinic
Houston, Texas, 77025
Hanger Clinic
Sarasota, Florida, 34233
Hanger Clinic
Seattle, Washington, 98116
About this study
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
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
Read the 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.
- Conditions
- Pareses, Lower Extremity
- Being tested
- C-Brace, KAFO/SCO
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-BraceDevice
Also called Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)
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.
KAFO/SCODevice
Also called Locked KAFO, Posterior offset KAFO, Stance Control Orthosis
Current knee ankle foot orthosis that the subject was wearing at baseline
| Study group | Role | What they receive |
|---|---|---|
| KAFO/SCO | Active comparator | Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) Receives: Device: KAFO/SCO |
| C-Brace | Experimental | Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. Receives: Device: C-Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Measured: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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
Measured: 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.
Measured: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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
Measured: 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.
Measured: 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). 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 1=much worse and 5=much better.
Measured: 3 months after cross-over home use period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start11 Mar 2019
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pareses, Lower ExtremityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective international multi-center, open-labeled randomized, controlled cross-over trial
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock Healthcare Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Braatz, Dr. med., Principal investigator, Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906656
- Sponsor's protocol ID
- PS00120016A-001
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37752724
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03906656
- Acronym / sponsor ID
- PS00120016A-001
- Conditions
- Pareses, Lower Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Otto Bock Healthcare Products GmbHIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective international multi-center, open-labeled randomized, controlled cross-over trial
| Arm | Type | Receives |
|---|---|---|
| KAFO/SCO | Active comparator | Device: KAFO/SCOHome use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO) |
| C-Brace | Experimental | Device: C-BraceHome use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-BraceAlso: Microprocessor-controlled Stance and Swing Orthosis (MP-SSCO)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. | Device | C-Brace |
| KAFO/SCOAlso: Locked KAFO, Posterior offset KAFO, Stance Control OrthosisCurrent knee ankle foot orthosis that the subject was wearing at baseline | Device | KAFO/SCO |
Primary outcome
Primary Efficacy: Berg Balance Scale (BBS)
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
14 secondary outcomes
Activity-specific Balance Confidence (ABC) Scale
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Dynamic Gait Index (DGI)
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
6-minute Walk Test
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Stair Assessment Index (SAI) - Down
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Frequency of Falling
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Fear of Falling
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO
Time frame: 3 months after initial home use period, and 3 months after cross-over home use period
Reintegration to Normal Living (RNL) Index Questionnaire
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
EQ-5D-5L
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Work Limitations Questionnaires WLQ-25
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Orthotics & Prosthetics User Survey (OPUS)
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Medical Outcomes Study Short Form (SF-36)
Time frame: 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)
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Patient-Related Outcome Questions
Time frame: 3 months after cross-over home use period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37752724Ruetz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Braatz, Dr. med. principal investigator
Zentrum für Healthcare Technology der Privaten Hochschule Göttingen
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Brace and KAFO/SCO in people with Pareses, Lower Extremity, run by Otto Bock Healthcare Products GmbH at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, United States, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy: Berg Balance Scale (BBS) (time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03906656, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.