C-brace for Arthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Arthritis+4 MoreC-brace - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare how well the C-Brace improves mobility for people with leg problems due to disease or injury, compared to a standard leg brace.

Eligible Conditions
  • Arthritis
  • Post-polio Syndrome
  • Polio
  • Spinal Cord Injury
  • Lower Motor Neuron Lesion

Treatment Effectiveness

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.

Week 16
5 times sit to stand test
Week 16
Six minute walk test (6MWT)
Week 16
Berg Balance Scale
Week 16
Functional Gait Assessment
Week 16
Modified Falls Efficacy Scale
Week 16
Orthotics and Prosthetics User Survey
Week 16
World Health Organization Quality of Life, brief form (WHOQOL-BREF)
Week 16
GAITRite Data Capture
Week 16
10 meter walk test
Week 16
Hill Assessment Index
Week 16
Muscle strength
Week 16
Passive and active range of motion
Week 16
Stair Assessment Index
Week 16
Cross Walk Blinking Signal Test
Week 16
Actigraph
Global Positioning System (GPS)
Metria Sensor A wireless wearable sensor used in conjunction with the Actigraph to measure activity and monitor vitals and energy use during functional activities.

Trial Safety

Trial Design

2 Treatment Groups

C-brace then stance control orthosis
1 of 2
Stance control orthosis then C-brace
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: C-brace · No Placebo Group · N/A

C-brace then stance control orthosisExperimental Group · 2 Interventions: C-brace, Stance control orthosis · Intervention Types: Device, Device
Stance control orthosis then C-braceExperimental Group · 2 Interventions: C-brace, Stance control orthosis · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline measurement after device 1 training at 8 weeks and after device 2 training at 16 weeks.

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,678 Total Patients Enrolled
Otto Bock Healthcare Products GmbHIndustry Sponsor
14 Previous Clinical Trials
588 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

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