post-polio syndroom, trauma, neurologische aandoeningen zoals multiple sclerose en polyneuropathieen damage to the spinal cord incomplete spinal cord injury
Conditions
Interventions
A computer-controlled knee-ankle-foot orthosis called a C-Brace,
knee-ankle-foot orthosis, dynamic long leg brace.
Sponsors
Otto Bock BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patiënt with an unilateral paresis/paralysis of the lower extremity • Patient is >= 18 years old • Prior active and compliant use of unilateral or bilateral KAFO or SCO in the past 3 months prior to enrollment in the study • Patient has been tested with the Trial Tool (DTO) and demonstrated the potential to utilize the C-Brace successfully • Patient has a BBS score
Exclusion criteria
Exclusion criteria: • 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 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 mm Patient with unstable neurological or cardiovascular/pulmonary disease, cancer • Patient is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Berg Balance Scale. This is a validated and widely used 14-item scale developed to measure balance in adults. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical tests: Dynamic Gait Index (DGI) Stair Assessment Index (SAI) 6-minute walk test Questionnaires: Activity-specific balance confidence (ABC) Scale EQ-5D-5L Medical Outcomes Study Short Form (SF-36) Orthotics & Prosthetics User Survey (OPUS) Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) Reintegration to Normal Living (RNL) Index questionnaire Work limitations questionnaires WLQ-25 | — |
Countries
Netherlands
Outcome results
None listed