18 and older, any sex, with Pareses, Lower Extremity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Primary Efficacy: Berg Balance Scale (BBS)Primary· 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.
Group
Value
95% CI
Baseline
33.6
± 11.0
KAFO
37.3
± 10.5
C-Brace
42.0
± 9.1
Activity-specific Balance Confidence (ABC) ScaleSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Group
Value
95% CI
Baseline
53.1
± 19.2
KAFO
51.0
± 18.3
C-Brace
62.3
± 19.5
Dynamic Gait Index (DGI)Secondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Group
Value
95% CI
Baseline
12.3
± 3.3
KAFO
13.4
± 3.2
C-Brace
15.7
± 3.3
6-minute Walk TestSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.
Group
Value
95% CI
Baseline
204.9
± 73.9
KAFO
213.7
± 80.9
C-Brace
226.0
± 84.3
Stair Assessment Index (SAI) - DownSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Group
Value
95% CI
Baseline
4
± 3.3
KAFO
4.5
± 3.5
C-Brace
6
± 4.2
Frequency of FallingSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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
Group
Value
95% CI
Baseline
4.9
± 20.1
KAFO
4.0
± 16.8
C-Brace
1.1
± 3.3
Fear of FallingSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Fear of falling indoors
Group
Value
95% CI
Baseline
3.3
± 2.9
KAFO
3.3
± 2.8
C-Brace
2.2
± 2.6
Fear of falling outdoors
Group
Value
95% CI
Baseline
5.5
± 3.0
KAFO
5.2
± 2.9
C-Brace
4.4
± 3.0
Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCOSecondary· 3 months after initial home use period, and 3 months after cross-over home use period
Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods
Group
Value
95% CI
KAFO
25
C-Brace
12
Reintegration to Normal Living (RNL) Index QuestionnaireSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Group
Value
95% CI
Baseline
71.5
± 19.8
KAFO
71.7
± 17.6
C-Brace
74.0
± 19.8
EQ-5D-5LSecondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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).
Group
Value
95% CI
Baseline
0.71
± 0.19
KAFO
0.72
± 0.19
C-Brace
0.74
± 0.18
Work Limitations Questionnaires WLQ-25Secondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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).
Mental/Interpersonal
Group
Value
95% CI
Baseline
86.1
± 13.3
KAFO
88.4
± 11.5
C-Brace
91.0
± 13.7
Output
Group
Value
95% CI
Baseline
82.0
± 17.9
KAFO
81.9
± 17.0
C-Brace
84.6
± 17.3
Physical
Group
Value
95% CI
Baseline
37.5
± 24.8
KAFO
34.5
± 23.3
C-Brace
24.3
± 18.8
Time
Group
Value
95% CI
Baseline
79.2
± 20.1
KAFO
78.3
± 24.6
C-Brace
79.8
± 19.8
Orthotics & Prosthetics User Survey (OPUS)Secondary· Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
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.
Quality of Life
Group
Value
95% CI
Baseline
56.6
± 7.3
KAFO
56.9
± 6.9
C-Brace
58.0
± 8.0
Lower Extremity Functional Status
Group
Value
95% CI
Baseline
45.3
± 6.2
KAFO
46.6
± 6.3
C-Brace
48.8
± 6.3
Satisfaction with Device
Group
Value
95% CI
Baseline
49.8
± 10.5
KAFO
50.6
± 9.7
C-Brace
51.3
± 13.7
Adverse events — posted to ClinicalTrials.gov
Time frame: For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otto Bock Healthcare Products GmbH
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03906656.