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C-Brace II for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Spinal Cord InjuryC-Brace II - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial compares two types of knee-ankle-foot braces to see which is more effective following discharge from inpatient rehab.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Change from baseline in score after using device at 3, 6, and 12 month follow-up.

Month 12
Six Minute Walk Test (6MWT)
Month 12
Berg Balance Scale (BBS)
Month 12
Functional Gait Assessment (FGA)
Month 12
Timed Up and Go test (TUG)
Month 12
Gaitrite data capture
Month 12
10 Meter Walk Test (10MWT)
Month 12
Muscle Strength (manual muscle test)
Month 12
Modified Ashworth Scale
Month 12
Passive and Active Range of Motion of Lower Extremity joints
Month 12
Walking Index for Spinal Cord Injury (WISCI II)
Month 12
Activities Specific Balance Confidence Scale (ABC)
EQ5D-5L
International Spinal Cord Injury Bowel Function Data Set
International Spinal Cord Injury Lower urinary Tract Basic Data Set
Modified Falls Efficacy Scale (mFES)
Orthotics and Prosthetics User Survey (OPUS)
Spinal Cord Injury Bowel and Bladder Treatment Index Short Form (SCI-BBTI-SF)
Spinal Cord Injury Quality of Life (SCI-QOL)
World Health Organization Quality of Life (WHOQOL-BREF)
Month 12
Actigraph

Trial Safety

Safety Progress

1 of 3

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2
Lactobacillus RhamnosusGG
2
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Trial Design

2 Treatment Groups

Traditional Group
1 of 2
C-Brace II Group
1 of 2

Active Control

Experimental Treatment

30 Total Participants · 2 Treatment Groups

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

C-Brace II Group
Device
Experimental Group · 1 Intervention: C-Brace II · Intervention Types: Device
Traditional Group
Device
ActiveComparator Group · 1 Intervention: Traditional Care KAFO intervention · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline in score after using device at 3, 6, and 12 month follow-up.

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
173 Previous Clinical Trials
13,672 Total Patients Enrolled
Otto Bock Healthcare Products GmbHIndustry Sponsor
14 Previous Clinical Trials
582 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to demonstrate the ability to charge assigned sensors during 3-month home trial period on and off and sufficient memory ability to wear the devices each day during use of the orthoses.
References

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