N/A
Completed N=102
Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)
Pareses, Lower Extremity
Source: ClinicalTrials.gov NCT03906656 ↗
Enrolled (actual)
102
Serious AEs
8.4%
Results posted
Sep 2024
Primary outcomePrimary: Primary Efficacy: Berg Balance Scale (BBS) — 33.6; 37.3; 42.0 score on a scale — p=0.0002
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy: Berg Balance Scale (BBS) |
33.6; 37.3; 42.0 | 0.0002 sig |
| SECONDARY Activity-specific Balance Confidence (ABC) Scale |
53.1; 51.0; 62.3 | 0.005 sig |
| SECONDARY Dynamic Gait Index (DGI) |
12.3; 13.4; 15.7 | 0.005 sig |
| SECONDARY 6-minute Walk Test |
204.9; 213.7; 226.0 | 0.583 |
| SECONDARY Stair Assessment Index (SAI) - Down |
4; 4.5; 6 | 0.0078 sig |
| SECONDARY Frequency of Falling |
4.9; 4.0; 1.1 | 0.0020 sig |
| SECONDARY Fear of Falling |
3.3; 3.3; 2.2; 5.5; 5.2; 4.4 | 0.0023 sig |
| SECONDARY Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO |
25; 12 | 0.006 sig |
| SECONDARY Reintegration to Normal Living (RNL) Index Questionnaire |
71.5; 71.7; 74.0 | 0.08 |
| SECONDARY EQ-5D-5L |
0.71; 0.72; 0.74 | 0.151 |
| SECONDARY Work Limitations Questionnaires WLQ-25 |
86.1; 88.4; 91.0; 82.0; 81.9; 84.6 | 0.281 |
| SECONDARY Orthotics & Prosthetics User Survey (OPUS) |
56.6; 56.9; 58.0; 45.3; 46.6; 48.8 | 0.00019 sig |
| SECONDARY Medical Outcomes Study Short Form (SF-36) |
76.2; 75.5; 79.2; 52.2; 52.3; 56.8 | 0.0226 sig |
| SECONDARY Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) |
4.05; 4.05; 4.00; 4.60; 4.66; 4.79 | 0.301 |
| SECONDARY Patient-Related Outcome Questions |
4; 4; 4; 4 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03906656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.