Pareses, Lower Extremity
Conditions
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.
Interventions
DEVICEC-Brace
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.
DEVICEKAFO/SCO
Current knee ankle foot orthosis that the subject was wearing at baseline
Sponsors
Otto Bock Healthcare Products GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective international multi-center, open-labeled randomized, controlled cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy: Berg Balance Scale (BBS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | 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. |
| 6-minute Walk Test | 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. |
| Stair Assessment Index (SAI) - Down | 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. |
| Frequency of Falling | 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 |
| Fear of Falling | 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. |
| Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO | 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 |
| Activity-specific Balance Confidence (ABC) Scale | 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. |
| EQ-5D-5L | 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). |
| Work Limitations Questionnaires WLQ-25 | 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). |
| Orthotics & Prosthetics User Survey (OPUS) | 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. |
| Medical Outcomes Study Short Form (SF-36) | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 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) | Baseline, 3 months after initial home use period, and 3 months after cross-over home use period | 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 | 3 months after cross-over home use period | 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. |
| Reintegration to Normal Living (RNL) Index Questionnaire | 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. |
Countries
Austria, Germany, Netherlands, United States
Participant flow
Recruitment details
Potential participants were pre-screened based on their medical and/or orthotic records. After signing a written informed consent, participants were screened for inclusion and exclusion criteria. The screening process comprised a thorough patient evaluation and a test with the functional C-Brace trial tool to check whether the potential study participant was able to initiate swing and utilize controlled knee flexion during weight bearing.
Pre-assignment details
149 subjects were enrolled, and 41 failed screening (27 due to BBS score above 44, 11 failed the C-Brace trial tool assessment, 1 had a contraindication for the C-Brace, 1 had a history of vertigo, and 1 was geographically inaccessible). In addition, another 6 subjects dropped out after screening, but prior to randomization. Reasons for these early dropouts were lack of time (2) and personal problems (1) resulting in 102 patients randomized.
Participants by arm
| Arm | Count |
|---|---|
| KAFO/SCO, Then C-Brace Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely. | 52 |
| C-Brace, Then KAFO/SCO Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: 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.
Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period. | 50 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Fitting/Assessment Prior to Home Use 1 | Adverse Event | 0 | 1 |
| Fitting/Assessment Prior to Home Use 1 | Lack of access to site during COVID | 0 | 1 |
| Fitting/Assessment Prior to Home Use 1 | Lack of Efficacy | 0 | 1 |
| Fitting/Assessment Prior to Home Use 1 | Lost to Follow-up | 1 | 0 |
| Fitting/Assessment Prior to Home Use 1 | Withdrawal by Subject | 1 | 0 |
| Fitting/Assessment Prior to Home Use 2 | Adverse Event | 2 | 0 |
| Fitting/Assessment Prior to Home Use 2 | Lack of access to site during COVID | 1 | 0 |
| Fitting/Assessment Prior to Home Use 2 | Lack of Efficacy | 1 | 0 |
| Fitting/Assessment Prior to Home Use 2 | Lost to Follow-up | 1 | 0 |
| Fitting/Assessment Prior to Home Use 2 | Personal problems | 0 | 1 |
| Fitting/Assessment Prior to Home Use 2 | Withdrawal by Subject | 1 | 0 |
| Home Use 1 (3 Months) | Adverse Event | 1 | 2 |
| Home Use 1 (3 Months) | Lack of Efficacy | 0 | 1 |
| Home Use 1 (3 Months) | Protocol Violation | 1 | 0 |
| Home Use 1 (3 Months) | Withdrawal by Subject | 1 | 0 |
| Home Use 2 (3 Months) | Adverse Event | 1 | 1 |
| Home Use 2 (3 Months) | Could not cope with KAFO after C-Brace | 0 | 1 |
| Home Use 2 (3 Months) | Death | 2 | 0 |
| Home Use 2 (3 Months) | Lack of Efficacy | 1 | 0 |
| Home Use 2 (3 Months) | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | C-Brace, Then KAFO/SCO | Total | KAFO/SCO, Then C-Brace |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 12.4 | 55.8 years STANDARD_DEVIATION 13.8 | 56.1 years STANDARD_DEVIATION 15.2 |
| Body Weight | 82.8 kg STANDARD_DEVIATION 16.3 | 80.1 kg STANDARD_DEVIATION 16.2 | 77.5 kg STANDARD_DEVIATION 15.8 |
| Height | 170.3 cm STANDARD_DEVIATION 11.3 | 170.2 cm STANDARD_DEVIATION 11.2 | 170.1 cm STANDARD_DEVIATION 11.3 |
| Race/Ethnicity, Customized Asian | 6 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 38 Participants | 78 Participants | 40 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment Austria | 1 participants | 1 participants | 0 participants |
| Region of Enrollment Germany | 24 participants | 52 participants | 28 participants |
| Region of Enrollment Netherlands | 3 participants | 7 participants | 4 participants |
| Region of Enrollment United States | 22 participants | 42 participants | 20 participants |
| Sex: Female, Male Female | 19 Participants | 45 Participants | 26 Participants |
| Sex: Female, Male Male | 31 Participants | 57 Participants | 26 Participants |
| Side/bilateral orthosis Bilateral | 6 Participants | 14 Participants | 8 Participants |
| Side/bilateral orthosis Left | 21 Participants | 47 Participants | 26 Participants |
| Side/bilateral orthosis Right | 23 Participants | 41 Participants | 18 Participants |
| Type of orthosis used before study and as control Locked KAFO | 23 participants | 45 participants | 22 participants |
| Type of orthosis used before study and as control Other | 1 participants | 2 participants | 1 participants |
| Type of orthosis used before study and as control Posterior-offset KAFO | 14 participants | 29 participants | 15 participants |
| Type of orthosis used before study and as control SCO (electrical) | 5 participants | 14 participants | 9 participants |
| Type of orthosis used before study and as control SCO (mechanical) | 13 participants | 24 participants | 11 participants |
| Use of walking aids inside No | 20 Participants | 40 Participants | 20 Participants |
| Use of walking aids inside Yes | 30 Participants | 61 Participants | 31 Participants |
| Use of walking aids outside No | 8 Participants | 15 Participants | 7 Participants |
| Use of walking aids outside Yes | 42 Participants | 86 Participants | 44 Participants |
| Work/employment status Employed | 25 Participants | 42 Participants | 17 Participants |
| Work/employment status Retired | 21 Participants | 43 Participants | 22 Participants |
| Work/employment status Unemployed | 4 Participants | 17 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 2 / 88 |
| other Total, other adverse events | 66 / 102 | 57 / 88 |
| serious Total, serious adverse events | 10 / 102 | 6 / 88 |
Outcome results
Primary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Primary Efficacy: Berg Balance Scale (BBS) | 33.6 score on a scale | Standard Deviation 11 |
| KAFO | Primary Efficacy: Berg Balance Scale (BBS) | 37.3 score on a scale | Standard Deviation 10.5 |
| C-Brace | Primary Efficacy: Berg Balance Scale (BBS) | 42.0 score on a scale | Standard Deviation 9.1 |
Comparison: H0: the mean difference (C-Brace - KAFO) \<= 0.p-value: 0.0002t-test, 2 sided
Comparison: H0: the mean difference (C-Brace - Baseline) \<= 0.p-value: <0.00001t-test, 2 sided
Comparison: KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.p-value: <0.00001t-test, 2 sided
Secondary
6-minute Walk Test
Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | 6-minute Walk Test | 204.9 meters | Standard Deviation 73.9 |
| KAFO | 6-minute Walk Test | 213.7 meters | Standard Deviation 80.9 |
| C-Brace | 6-minute Walk Test | 226.0 meters | Standard Deviation 84.3 |
Comparison: H0: the median of the population differences (C-Brace - KAFO) \<= 0.p-value: 0.583Wilcoxon Signed Rank Test
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Activity-specific Balance Confidence (ABC) Scale | 53.1 score on a scale | Standard Deviation 19.2 |
| KAFO | Activity-specific Balance Confidence (ABC) Scale | 51.0 score on a scale | Standard Deviation 18.3 |
| C-Brace | Activity-specific Balance Confidence (ABC) Scale | 62.3 score on a scale | Standard Deviation 19.5 |
Comparison: H0: the mean difference (C-Brace - KAFO) \<= 0p-value: 0.005t-test, 2 sided
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Dynamic Gait Index (DGI) | 12.3 score on a scale | Standard Deviation 3.3 |
| KAFO | Dynamic Gait Index (DGI) | 13.4 score on a scale | Standard Deviation 3.2 |
| C-Brace | Dynamic Gait Index (DGI) | 15.7 score on a scale | Standard Deviation 3.3 |
Comparison: H0: the mean difference (C-Brace - KAFO) \<= 0.p-value: 0.005t-test, 2 sided
Secondary
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).
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | EQ-5D-5L | 0.71 score on a scale | Standard Deviation 0.19 |
| KAFO | EQ-5D-5L | 0.72 score on a scale | Standard Deviation 0.19 |
| C-Brace | EQ-5D-5L | 0.74 score on a scale | Standard Deviation 0.18 |
Comparison: H0: the median of the population differences (C-Brace - KAFO) \<= 0p-value: 0.151Wilcoxon Signed Rank Test
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Fear of Falling | Fear of falling indoors | 3.3 score on a scale | Standard Deviation 2.9 |
| Baseline | Fear of Falling | Fear of falling outdoors | 5.5 score on a scale | Standard Deviation 3 |
| KAFO | Fear of Falling | Fear of falling indoors | 3.3 score on a scale | Standard Deviation 2.8 |
| KAFO | Fear of Falling | Fear of falling outdoors | 5.2 score on a scale | Standard Deviation 2.9 |
| C-Brace | Fear of Falling | Fear of falling indoors | 2.2 score on a scale | Standard Deviation 2.6 |
| C-Brace | Fear of Falling | Fear of falling outdoors | 4.4 score on a scale | Standard Deviation 3 |
Comparison: H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)p-value: 0.0023Wilcoxon Signed Rank Test
p-value: 0.0066Wilcoxon Signed Rank Test
Secondary
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
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Frequency of Falling | 4.9 number of falls in a three month period | Standard Deviation 20.1 |
| KAFO | Frequency of Falling | 4.0 number of falls in a three month period | Standard Deviation 16.8 |
| C-Brace | Frequency of Falling | 1.1 number of falls in a three month period | Standard Deviation 3.3 |
p-value: 0.002Wilcoxon Signed Rank Test
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Medical Outcomes Study Short Form (SF-36) | Health Change | 47.4 score on a scale | Standard Deviation 24.2 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Social Functioning | 74.2 score on a scale | Standard Deviation 23 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Physical Functioning | 29.7 score on a scale | Standard Deviation 22.6 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Pain | 55.6 score on a scale | Standard Deviation 25.3 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Emotional Wellbeing | 76.2 score on a scale | Standard Deviation 16.4 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Role limitations due to physical health | 36.5 score on a scale | Standard Deviation 39.7 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | General Health | 54.1 score on a scale | Standard Deviation 22.2 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Energy/Fatigue | 52.2 score on a scale | Standard Deviation 21.3 |
| Baseline | Medical Outcomes Study Short Form (SF-36) | Role limitations due to emotional problems | 78.1 score on a scale | Standard Deviation 36.9 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Pain | 57.4 score on a scale | Standard Deviation 24.9 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Emotional Wellbeing | 75.5 score on a scale | Standard Deviation 16.3 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Energy/Fatigue | 52.3 score on a scale | Standard Deviation 20.3 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | General Health | 54.2 score on a scale | Standard Deviation 23.8 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Health Change | 48.0 score on a scale | Standard Deviation 26 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Physical Functioning | 31.1 score on a scale | Standard Deviation 23.8 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Role limitations due to emotional problems | 82.2 score on a scale | Standard Deviation 34.3 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Role limitations due to physical health | 44.9 score on a scale | Standard Deviation 43.2 |
| KAFO | Medical Outcomes Study Short Form (SF-36) | Social Functioning | 75.1 score on a scale | Standard Deviation 25 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | General Health | 58.2 score on a scale | Standard Deviation 23.8 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Emotional Wellbeing | 79.2 score on a scale | Standard Deviation 15.16 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Role limitations due to emotional problems | 86.1 score on a scale | Standard Deviation 28.8 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Energy/Fatigue | 56.8 score on a scale | Standard Deviation 20.1 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Social Functioning | 77.3 score on a scale | Standard Deviation 24.4 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Pain | 59.5 score on a scale | Standard Deviation 26.7 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Health Change | 56.5 score on a scale | Standard Deviation 26.4 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Role limitations due to physical health | 51.0 score on a scale | Standard Deviation 41.2 |
| C-Brace | Medical Outcomes Study Short Form (SF-36) | Physical Functioning | 44.3 score on a scale | Standard Deviation 23.3 |
Comparison: Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.p-value: 0.0226t-test, 2 sided
Comparison: Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.p-value: 0.002t-test, 2 sided
Comparison: Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.p-value: 0.0049Wilcoxon Signed Rank Test
Comparison: Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0p-value: 0.0000647t-test, 2 sided
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Orthotics & Prosthetics User Survey (OPUS) | Lower Extremity Functional Status | 45.3 score on a scale | Standard Deviation 6.2 |
| Baseline | Orthotics & Prosthetics User Survey (OPUS) | Quality of Life | 56.6 score on a scale | Standard Deviation 7.3 |
| Baseline | Orthotics & Prosthetics User Survey (OPUS) | Satisfaction with Device | 49.8 score on a scale | Standard Deviation 10.5 |
| KAFO | Orthotics & Prosthetics User Survey (OPUS) | Lower Extremity Functional Status | 46.6 score on a scale | Standard Deviation 6.3 |
| KAFO | Orthotics & Prosthetics User Survey (OPUS) | Quality of Life | 56.9 score on a scale | Standard Deviation 6.9 |
| KAFO | Orthotics & Prosthetics User Survey (OPUS) | Satisfaction with Device | 50.6 score on a scale | Standard Deviation 9.7 |
| C-Brace | Orthotics & Prosthetics User Survey (OPUS) | Quality of Life | 58.0 score on a scale | Standard Deviation 8 |
| C-Brace | Orthotics & Prosthetics User Survey (OPUS) | Satisfaction with Device | 51.3 score on a scale | Standard Deviation 13.7 |
| C-Brace | Orthotics & Prosthetics User Survey (OPUS) | Lower Extremity Functional Status | 48.8 score on a scale | Standard Deviation 6.3 |
Comparison: OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0p-value: 0.00019t-test, 2 sided
Secondary
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.
Time frame: 3 months after cross-over home use period
Population: Subjects that answered the patient-reported outcome questions after having completed home-use periods with both KAFO/SCO and C-Brace (at Visit 2). 75 subjects provided answers to these questions.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline | Patient-Related Outcome Questions | To what extent has the C-Brace enabled you to engage in the activities that you enjoy? | 4 units on a scale |
| Baseline | Patient-Related Outcome Questions | To what extent has the C-Brace impacted your quality of life? | 4 units on a scale |
| KAFO | Patient-Related Outcome Questions | To what extent has the C-Brace enabled you to engage in the activities that you enjoy? | 4 units on a scale |
| KAFO | Patient-Related Outcome Questions | To what extent has the C-Brace impacted your quality of life? | 4 units on a scale |
Secondary
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
Time frame: 3 months after initial home use period, and 3 months after cross-over home use period
Population: Paired data including subjects with fall history after both KAFO and C-Brace home use periods
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline | Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO | 25 Participants |
| KAFO | Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO | 12 Participants |
Comparison: Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.p-value: 0.006McNemar
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Service | 4.60 score on a scale | Standard Deviation 0.64 |
| Baseline | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Device | 4.05 score on a scale | Standard Deviation 0.67 |
| Baseline | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Total | 4.23 score on a scale | Standard Deviation 0.59 |
| KAFO | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Service | 4.66 score on a scale | Standard Deviation 0.7 |
| KAFO | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Device | 4.05 score on a scale | Standard Deviation 0.72 |
| KAFO | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Total | 4.27 score on a scale | Standard Deviation 0.64 |
| C-Brace | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Device | 4.00 score on a scale | Standard Deviation 0.63 |
| C-Brace | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Total | 4.27 score on a scale | Standard Deviation 0.49 |
| C-Brace | Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST) | Service | 4.79 score on a scale | Standard Deviation 0.42 |
Comparison: Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0p-value: 0.301Wilcoxon Signed Rank Test
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Reintegration to Normal Living (RNL) Index Questionnaire | 71.5 score on a scale | Standard Deviation 19.8 |
| KAFO | Reintegration to Normal Living (RNL) Index Questionnaire | 71.7 score on a scale | Standard Deviation 17.6 |
| C-Brace | Reintegration to Normal Living (RNL) Index Questionnaire | 74.0 score on a scale | Standard Deviation 19.8 |
Comparison: H0: the median of the population differences (C-Brace - KAFO) \<= 0.p-value: 0.08Wilcoxon Signed Rank Test
Secondary
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.
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Stair Assessment Index (SAI) - Down | 4 score on a scale | Standard Deviation 3.3 |
| KAFO | Stair Assessment Index (SAI) - Down | 4.5 score on a scale | Standard Deviation 3.5 |
| C-Brace | Stair Assessment Index (SAI) - Down | 6 score on a scale | Standard Deviation 4.2 |
Comparison: H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)p-value: 0.0078Wilcoxon Signed Rank Test
Secondary
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).
Time frame: Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Population: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Work Limitations Questionnaires WLQ-25 | Mental/Interpersonal | 86.1 score on a scale | Standard Deviation 13.3 |
| Baseline | Work Limitations Questionnaires WLQ-25 | Output | 82.0 score on a scale | Standard Deviation 17.9 |
| Baseline | Work Limitations Questionnaires WLQ-25 | Physical | 37.5 score on a scale | Standard Deviation 24.8 |
| Baseline | Work Limitations Questionnaires WLQ-25 | Time | 79.2 score on a scale | Standard Deviation 20.1 |
| KAFO | Work Limitations Questionnaires WLQ-25 | Time | 78.3 score on a scale | Standard Deviation 24.6 |
| KAFO | Work Limitations Questionnaires WLQ-25 | Mental/Interpersonal | 88.4 score on a scale | Standard Deviation 11.5 |
| KAFO | Work Limitations Questionnaires WLQ-25 | Physical | 34.5 score on a scale | Standard Deviation 23.3 |
| KAFO | Work Limitations Questionnaires WLQ-25 | Output | 81.9 score on a scale | Standard Deviation 17 |
| C-Brace | Work Limitations Questionnaires WLQ-25 | Time | 79.8 score on a scale | Standard Deviation 19.8 |
| C-Brace | Work Limitations Questionnaires WLQ-25 | Output | 84.6 score on a scale | Standard Deviation 17.3 |
| C-Brace | Work Limitations Questionnaires WLQ-25 | Physical | 24.3 score on a scale | Standard Deviation 18.8 |
| C-Brace | Work Limitations Questionnaires WLQ-25 | Mental/Interpersonal | 91.0 score on a scale | Standard Deviation 13.7 |
Comparison: WLQ-25 - Physicalp-value: 0.281t-test, 2 sided